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0-5 years of experience
Managed five project staff and 25 super user team. Handled project planning, implementation, and support for clinical systems project. Led and managed project development from inception to completion in four hospital, healthcare facility sites. Provided strategic planning and education development of new model of health information interchange and automation in healthcare. Utilized project management and informatics management methodologies in system development life cycle. Assisted staff in utilizing capability of clinical systems and buy in. Provided written and verbal status reports. Managed daily activities of multiple subject matter experts during activation support.
- Created hospital intranet tool to execute major designs and redesign in policies, education, and educational updates for technology projects.
- Delivered high level recommendations to executives for strategies to improve efficiency and quality of health care services.
- Participated in analysis, design, and implementation of barcode medication administration, hospital and ambulatory EMR.
- Provided project planning for multiple informatics projects; developed and updated clinical workflow.
- Developed educational curriculum for new system implementation.
- Participated and administered flu vaccination, and wellness programs for executive and office members.
- Provided informatics guidance on meaningful use and new pipeline system projects.
0-5 years of experience
Coordinated and managed the day-to-day activities associated with the acquisition, processing, read sessions and data output deliverables for the medical imaging component of clinical trials for corporate clients in the Pharmaceutical, Biotechnology and Medical Device industry.
- Held kick-off meeting to assemble project teams, assigned tasks, and delegated responsibilities, identified resources and reviewed detailed timelines, to ensure timely completion of assigned studies.
- Prepared weekly reports for upper management, regarding status of projects.
- Defined staff development goals, and performance metrics.
- Completed revenue for 13 Oncology projects on a monthly basis.
- Traveled locally and internationally to present Imaging requirements at Investigator’s Meeting.
0-5 years of experience
Managed clinical research studies with blood glucose meters, test strips, clinical chemistry, and urine chemistry analyzers for diabetes.
- Managed and monitored clinical research projects at corporate headquarters and CRO’s.
- Completed the clinical section of 510K for FDA application approval.
- Collected, analyzed and summarized clinical data for submission to regulatory agencies for product approvals and marketing purposes.
- Established clinical study objectives, strategy, budget, research, prepare and revise clinical Investigational Plan in regulatory agencies and internal personnel.
- Trained clinical investigators and support staff on clinical protocols.
- Conducted site qualification visits, monitoring visits and closeout visits to ensure completeness and accuracy of collected data and site compliance.
0-5 years of experience
Exhibits sound familiarity from a user perspective for implementation of projects, including planning, managing, and coordinating project activities to ensure timely accomplishments of goals and objectives. Play a pivotal role in defining, developing, and determining funding limitations, time-frame, staffing requirements, procedures, and allotment of resources to various phases of projects. Perform due diligence while working with vendors and customers to develop project deliverables, risks, assumptions, key stakeholders, roles and responsibilities and budget.
- Ensured timely implementation of radiology and cardiology equipment, with stringently calculated cost factors.
- Led project and sales meetings with stakeholders to determine a course of action, and ensure timely completion of projects.
- Tracked actual performance against planned project performance, minutely analyze all variances, and maintains project control.
- Compiled project data, analyzes it, and prepares meaningful reports to be presented to senior management for decision making.
- Strictly adhered to all regulations, procedures, and ensures all Medicare requirements are met.
0-5 years of experience
Provided overall administrative and operational support; to the department and clients.
- Managed clinical research projects, to ensure on time performance.
- Negotiated study budgets and contract agreements for 15 sites.
- Assessed qualifications and capabilities of potential sites and investigators.
- Interviewed and screened 6 new hires.
6-10 years of experience
Supported project management and teams in oversight, administrative and budget process for implementation of National
Cooperative Surveillance Study (NCSS).
- Defined and ensured attainment of project deliverables, created and executed project plans, and facilitated communication between project resources and participants.
- Tracked expenditures, controlled multi-million dollar operating budget, planned and organized project logistics, and assisted in production of printed materials.
- Managed clinical database, monitored expenditures and budget of Rituxan and Herceptin drug worldwide, and attended all
- Involved in the Rituxan
- Led project team through Project Life Cycle to ensure quality implementation according to clearly detailed expectations and customer requirements by utilizing site-wide project management methodology.
- Identified and effectively utilize necessary resources and skill sets required to advance successful and sustainable project
- Communicated and managed relationships with functional and cross-functional team members to promote understanding,
- Developed and used metrics to measure progress and efficiency of team and met project goals, timelines and deliverables.
- Processed improvement that was sensitive to the diverse needs of the corporation, the site, our customers, and our team
0-5 years of experience
Led a matrixed, cross-functional study team; managed contractors, all-study-related data, central laboratories and study enrollment. Directly supervised clinical research associates and conducted training. Generated study documents, including protocol, informed consent forms, case report forms, monitoring guidelines and project specific documents.
- Ensured data quality and compliance by routinely participating in co-monitoring activities and mentoring CRAs and study team members assigned to a specific project.
- Recognized for effectively managing study budget and timeline commitments.
- Presented to investigators and clinical staff at Investigator Meetings to ensure proper training and understanding of the clinical trial process and protocol.
- Built effective physician relationships by representing the company to Key Opinion Leaders (KOL) and clinical investigators
0-5 years of experience
Coordinated implementation of 8 Hospital Patient Portal (web-based patient access) systems
- Managed migration of 50 Ambulatory clinics to a Patient Portal with Secure and Direct messaging
- Implemented MU-Stage 2 Secure message (Direct Message) across the enterprise
- Coordinated Cerner pilot for new healthcare delivery combining Wellness and clinical portals
0-5 years of experience
Therapeutic Areas: Pulmonary-Asthma -Phase III Global Trial; Cardiovascular-Phase III Global Trial; Oncology -Phase III Global Trial
- Coordinated with the Clinical Operations Team and Programmers to insure quality, accuracy, validation, and the timely delivery of the IVRS and Web-based EDC projects to the clients/sponsors
- Assisted the clients with any concerns/questions related to project requirements specification that may occur throughout the clinical trial process, keeping the project team informed of all changes to projects specifications as they occur
- Guided clients to successful use of the IVRS and EDC based and performed sponsor UATs
- Coordinated efforts to ensure project specification testing and validation for quality control on assigned projects adheres to ClinPhone Quality Assurance System and regulatory requirements at all times
- Designed project specification documentation, IVRS user manuals, and worksheets for individual projects in accordance with study protocol and client/sponsor needs
- Traveled to client sites and investigator meetings to present ClinPhone products related to clinical trial
0-5 years of experience
Therapeutic Areas: Neurology; Alzheimer’s Disease: Neuro-psychology; Schizophrenia
- Managed severe Alzheimer’s disease trial
- Reviewed regulatory packages for drug release
- Presented at investigator meetings
- Audited CRO’s monitoring at the sites
- Reviewed and approved CRF’s and source documents
- Wrote departmental SOP’s
0-5 years of experience
Supervised several teams of 6-10 people; multi-tasked the management of 16 to 20 studies involved with clinical trials
- Traveled 20% of the time nationally & internationally to give ECG training presentations for pharmaceutical personnel
- Met client needs by proactively replying to all emails within 24 hours – managed an average of 60 emails daily
- Utilized bilingual communication regularly with clients of numerous backgrounds/cultures to achieve client goals
- Interfaced with multiple departments, regularly placed significant equipment orders, & reviewed monthly invoices
0-5 years of experience
Led key projects successfully which resulted in on time delivery of data to the sponsors
- Monitored multiple databases to keep track of data and provide guidance to operational teams
- Represented project management in sponsors audits and presented
- Centralized all communication for the study team, senior management, and for the sponsor to ensure that all deliverables were accurate and fulfilled contractual obligations
- Managed up to 11 projects while streamlining processes and identifying gaps
- Repaired relationships with key sponsors with communication and effective planning
- Led and coordinated efforts of diverse global study teams, which included representatives from all functions supporting the study in OPS, ENG, IT, RAD, and BDE
- Manage direct and indirect reports including goal setting, training, development and performance management
0-5 years of experience
Managed and coordinated the development and execution of multiple aspects of clinical research studies, including but not limited to; clinical script development and site visit report template writing and review, regulatory document review, investigator and patient recruitment, enrollment and retention projects
- Provided management, training and work direction for projects’ Regional Research Managers
- Participated in business development activities in the pharmaceutical and biotechnology industries through presentations to current and prospective clients, and consulting in bid/proposal development
- Organized projects by assigning necessary responsibilities among members of an appropriately qualified project team and delivered project specific protocol training
- Maintained close control over project costs and provided forecast information to senior management and clients
- Provided timely and accurate project status and metric reports to client and internal team
- Assured compliance with all applicable ICH/GCP, FTC and FDA regulations, IRB/IEC parameters, and SOPS
- Developed and oversaw project matrices, timelines, recruitment/retention efforts and financial deliverables for multiple clinical research studies
0-5 years of experience
Study team leader; assisted in the writing and development of the protocol concept sheet and protocol of a Phase III seasonal allergic rhinitis study; developed Informed Consent template; assisted in the development of pro rata budget; facilitated the projection of key timelines and risks/issues
- Responsible for Investigator/Site Staff and CRA training
- Submission Team member; Project manager of Clinical’s regulatory deliverables for July 2009 sNDA submission; reviewed, contributed and QC’d CTD modules 2.7.4 Summary of Clinical Efficacy and 5.3.5.3 ISS; member of revised label working group as a reviewer/contributor.
- Vendor Management: assisted in preparation of RFO; participated in CRO bid defense meetings; reviewed bid/budget grids and work order agreements; active member during vendor kick-off meeting; primary point of contact for CRO
- Designed Inform screens and paper CRF diaries/pollen logs, regulatory guidelines and eCRF completion guidelines; closely tracked enrollment and sites requesting additional enrollment; corresponded with central IRB; coordinated data review meetings; oversaw data locks and transfers; assisted in the preparation of the Annual Study Report
- As an adjunct member of the SOP Committee for the Clinical Department across all therapy areas, revised and edited clinical SOPs, tested online SOP trainings, contributed to standardized Informed Consent template and checklist
0-5 years of experience
Planed and managed international clinical trials to achieve quality results.
- Supervised and assessed the performance of clinical team members.
- Conducted site visits and/or training, at study initiation, at regular intervals during the study and at study closeout.
- Monitored investigator performance and adherence to protocol; proactively addressed conduct and enrollment issues.
- Attended scientific/professional meetings and training courses as appropriate.
- Assisted in review of interim/final data listings prior to transmission to other groups or inclusion in interim/final reports.
- Conducted database audits according to established SOPs and is familiar with the implementation of GCPs
0-5 years of experience
- Managed all aspects of clinical trials, including trial conduct and staff oversight and training
- Developed and maintained clinical trial timelines and budgets
- Tracked study enrollment goals and developed metric reports for internal and external stakeholders
- Oversaw the contract negotiation process and managed the performance of internal and external consultants and other third parties to ensure study deliverables were met in accordance with the approved budget, federal and state regulations and applicable Standard Operating Procedures (SOPs)
- Oversaw data validation efforts, including plan and report generation
- Participated as a key contributor in strategic service meetings with senior management aimed at optimizing existing services as well as developing new departments and services within RCRI
0-5 years of experience
Project Manager for leading IVRS Services Provider to the Pharmaceutical Industry; responsible for the direct management of a minimum of five (5) studies concurrently
- Developed Project Specification and coordinate timelines for IVRS Platform design for pharmaceutical and biotech companies
- Designed user friendly IVRS Programs (randomization, medication assignment and diary)
- Coordinated client and internal validation (creation of validation plan, testing and reports for IVRS)
- Investigator Meeting presentations
- Oversaw and review data set releases for clients
- Managed studies with complex randomization schedules (multiple stratum), med management, diary calls, diary data collection
- Responsible for knowledge and adherence to 21 CFR PART 11
0-5 years of experience
Managed multiple large-scale Phase III & IV clinical studies budgeted up to $1M at various project development cycles; with responsibility of resources and timely problem resolution. Supervised diverse staff, including remote, domestic and international employees.
- Managed budgets, timelines and project plans ensuring quality and timely deliverables that resulted in improved client relations.
- Responsible for identifying appropriate central labs, data management companies, central IRBs, Key Opinion Leaders (KOL), to meet aggressive program budget & timelines.
- Encouraged collaboration through guidance and mentorship of assigned internal team members through hands on project management including trial planning, implementation, protocol & consent form development including DMPs, IRB submission, site recruitment and development of patient recruitment materials.
- Accountable for site and data management: ensured regulatory compliance, while improving site and patient recruitment goals, meeting aggressive timelines.
- Ensured GCP / ICH regulatory compliance on studies, preventing study deviations and provided swift resolutions to possible violations.
- Supervising and monitoring all work performed by team members and preparing all regulatory documents.
- Oversight of all data management activities to ensure data integrity including designing of electronic case report forms (eCRF’s), validation plan, SAE reporting and query generation/resolution.
- Updated SOP’s of contracted staff with suggested quality improvement and efficiency, thus saving thousands per project.
0-5 years of experience
Performed analysis and quality control of Holter monitor scans and electrocardiograms acquired
digitally from clinical trial patients in 5 concurrent research studies.
- Assisted in the verification of protocol-specific subject information for ECG and Holter studies, and was involved in management of the data query, which led to the resolution of possible
- Participated in clinical protocol development and applied the skills necessary when assistance
- Managed and reviewed technical/device descriptions and the regulatory affairs with regards to operation and service updates, product changes, new product development and regulatory
- Member of hiring team for new study technicians and supervisors and involved in training of new technicians.
0-5 years of experience
Coordinated activities related to deployment of the Army Warrior Care and Transition System (AWCTS) used in support of wounded, ill or injured Soldiers.
- Planned and coordinated system training program for 100 + military and civilian personnel.
- Developed policy and procedure guidelines for system users.
- Conducted data analysis for the Defense Health Program appropriations review process.
0-5 years of experience
Phase I, II, III, IIIB, IV
Therapeutic areas: Oncology, Lymphoma, Solid Tumors, Breast Cancer, Gastroenterology-Irritable Bowel Syndrome (Zelnorm), Infectious Disease-Herpes, Pain Management.
- Acted as a liaison between international and local operations groups, therapeutic areas, and departments for evaluation of new projects for phase I-IV clinical trials.
- Facilitated timely study trial allocation and execution, attended clinical team meetings, and generated study reports using IMPACT.
- Managed CROs study activities. Developed patient recruitment plans. Proactively planned for database locks. Reviewed data quality.
- Overall responsibility for the uneventful operation of clinical trials. Provided input on protocol design, and project milestones. Planned, managed and coordinated study and project team activities to ensure trials met or exceed objectives. Supervised field based CRAs.
- Managed project budget and authorized payments to investigators based on project milestones.
0-5 years of experience
- Prepared clinical project timelines, set milestones and anticipated obstacles
- Forecasted clinical product needs to for assigned protocols
- Managed budgets, negotiated and tracked expenditures with external partners
- Managed assigned Clinical Research Associates and Clinical Project Coordinators
- Organized and conducted Investigator and Safety Monitoring Board meetings
- Actively contributed to the preparation of clinical study reports
0-5 years of experience
- Provided leadership for clinical projects by directing the activities, training and development of clinical research associates and a CRO.
- Created and executed a project schedule and revised as appropriate to meet the changing needs and requirements of each project.
- Tracked project expenses and budget to ensure expectations remained on course.
- Delivered engaging, informative and well-organized presentations and communicated
- Prepared investigational plans consistent with Division goals and managed the final
- Assisted investigators in the preparation of manuscripts for publication and presentations of clinical study results.
- Approved key study documents including the consent form and case report form.
0-5 years of experience
Handled a team of 4 people in clinical research department and assisted/analyzed their work to meet organization’s objectives and goals
- Directed an innovative Growth Hormone program for patients on dialysis suffering from complications related to diabetes
- Worked with DaVita dialysis and large patient vendors to facilitate care and treatment
- Managed budgets, staffing
- Provided training and support to the team members
- Responsible for recruiting for clinical research department
0-5 years of experience
- Managed all clinical trial activities for rate control trials including protocol development, study reports, budgets, and audits, creation of request for proposals, review of vendor contracts, proposals and scope management
- Participated in strategic planning meetings with co-developers of rate and rhythm control compounds internal cross-functional project team meetings
- Reviewed and contributed to development of INDs, End of Phase II Briefing document, Investigator Brochures, and publications
- Implemented data review and study report review guidelines for more efficient review
0-5 years of experience
Managed the investigative sites by discussing and resolving protocol, budget, enrollment and staffing issues
- Ensured that the project status information was collected and distributed to upper management, the regulatory department and all study team members
- Directed, interacted and trained the CRAs and project coordinators to ensure that the project was properly monitored and the data was accurate
- Directed outside vendors including consultants and CROs with respect to the clinical trials
- Prepared and reviewed protocols, CSRs, CRFs and other study information
- Prepared and reviewed SOPs and ensured that procedures were appropriately and consistently applied to all study activities
- Negotiated budgets/contracts with investigators
- Developed monthly newsletters
- Responsible for the timely completion of all studies
- Assisted with the preparation of QA Audits
0-5 years of experience
Implemented risk management measures to keep assigned projects in alignment with original goals in order to avoid delays to patient outcomes.
- Planned, executed and assessed/revision of assigned programs/initiatives in support of MMRC’s fundamental business strategy of bringing new cancer treatments to patients rapidly.
- Tracked and reported MMRC trials to CMO/VP; driving site start up and enrollment plans on assigned trials.
- Provided guidance to industry on the role of MMRC Operations including the importance of setting timelines and mutual expectations during early stage of protocol concept development.
- Interacted with the CMO/VP/AD Ops, external vendors and site personnel i.e. investigators, MMPCs, their supervisors, to ensure MMRC’s goals and objectives are met i.e. resolution of internal and external issues delaying rapid start up and enrollment.
0-5 years of experience
Provided disease management and physician profiling studies to health plans and outcomes studies for pharmaceutical companies.
- Project Manager for new products with revenues ranging from $30,000 to $5 million
- Training liaison for clinical methodology between developers, programmers, and clinicians
- Managed client needs through initiating communications with clients, analysis of product intent and internal team building
- Developed problem/solution database in Microsoft Access that resulted in faster deliverables, reduction of programming errors and system inefficiencies
- Analyzed internal processes and developed solutions to provide efficiency improvements, cost savings, and improved associate knowledge of products
- Provided training for clients on product software and health care analysis reports
- Researched medical industry guidelines, trades and studies used to improve development and clinical validity of products
- Developed company newsletter
- Created and managed documentation for proprietary methodology
0-5 years of experience
- Provided project management and supervision for a professional research staff
- Created and implemented a quality improvement program
- Supervised the Transplant Case Management Department
- Standardized workflows and instituted process improvement guidelines
- Coordinated initiatives to combine evidence-based medicine with provider experience in development of Medical Policies and Utilization Guidelines
0-5 years of experience
- Co-developed and reviewed project budgets and timelines resulting in efficient, cost effective, on-time performance.
- Managed clinical projects during entire life-cycle including recruitment, start-up, study participation, maintenance and closeouts using reporting tools to generate and follow project performance and trend analysis.
- Developed and managed data collection for multiple clinical projects, NIH and other research and performed quality control review of collected data to ensure compliance with protocol requirements, domestic and global regulations to include CFR Part 11.
- Designed and administered MS Access databases for data collection/management.
0-5 years of experience
Served as lead project manager over full suites of clinical software solutions
- Gathered client requirements for new clinical documentation products
- Provided oversight in quality assurance testing
- Managed activation planning and on site activation support
0-5 years of experience
- Established study milestones and ensured accurate tracking and reporting of study metrics
- Performed ongoing vendor management (e.g., CROs, IVRS, imaging), including independent negotiation of scope of work, budgets, performance management, and issue resolution
- Created and managed clinical education, staff and resource plans for more than 80 clinical protocols in Phase II, III and IV
- Provided study-specific direction, generated performance reviews and mentored clinical trial coordinators and Specialist (CTS), provided support and mentored clinical trial regional managers
- Ensured trial adherence to ICH/GCP/local regulations, participated in clinical operations initiatives, time lines and programs as assigned
- Conducted more than 80 trials for (pacemakers, stents, catheters, adhesives, and CAPG) as well as pharmaceuticals (Oncology, Diabetes, Dermatology, Neurology, Transplant and General Practice)
- Responsible for development and analysis of all study close out reports
- Supervised a team of 74 investigators in an international trial for organ transplant registry study
0-5 years of experience
- Managed, monitored and coordinated the effort of clinical trial project teams
- Conducted site assessments, including site recruitment and activation, interim monitoring and close- out visits for cardiac PET perfusion imaging studies
- Performed co-monitoring visits in support of internal audits and project quality assurance activities
- Supported the development of the project budget and scope of work
- Conducted country level allocation including country and study level feasibility and assessments
0-5 years of experience
Ensure that radiology and cardiology equipment are implemented in a timely and efficient cost minded manner according to scope for the clients.
- This is accomplished by holding weekly or even daily team meetings per respective project stakeholders of each project whether it is regional or enterprise based.
- Once all stakeholders are satisfied with project completion then the projects are closed and transitioned to support.
- The projects are started and completed according to the stakeholder’s needs and end of life requirements of equipment in the scope of the projects.
- Meaningful use Medicare requirements are constantly being met in a timely manner.
0-5 years of experience
- Designed and implemented photographic protocols for major pharma clinical trials
- Monitored and managed multiple studies and was the single point of contact for all study-related matters
- Organized monitor reports and prepared PowerPoint presentations for investigator meetings
0-5 years of experience
Conceived and wrote clinical study protocols with an appropriate methodology integrated from the clinical development plan and regulatory strategy
- Quality Assurance Reviews of clinical development regulatory documents (i.e. briefing package, investigator brochure, protocols, etc.)
- Coordinated all clinical and operational activities locally/globally within the planned time frame/budget and in the sought quality according to internal Standard Operating Procedures (SOP) and Good Clinical Practices (GCP)
- Management of external vendors such as CROs and Central labs
- Managed compliance of all submissions to the Clinical Trial Registry
0-5 years of experience
Lead the development, management and implementation of evidence generation strategies and deliverables to support the reimbursement, regulatory and business objectives during drug development
- Developed strong understanding of global health care systems and built relationships with external Health Technology Assessment bodies/payer decision makers to garner insights into drug development
- Managed external partners (CRO) relationships – reviewing proposals, creating SOW, monitoring ongoing activities, project timelines, liaison with internal stakeholders, metrics assessments, budget tracking
- Managed global Health Technology Advisory Councils for payer insights into clinical development plan Worked in partnership with key internal and external stakeholders to ensure alignment of therapeutic area strategies to support internal decision making
- Proactively educated internal matrix partners on evolving global payer/HTA needs to ensure buy in for proposed product development strategies
- Key member of team for R&D portfolio evaluation (>100 indications) using novel multi-criteria decision analysis tool
- Led the development and implementation of strategic action plan template
- Ensured deliverables of high scientific quality, meeting internal and external quality standards
- Spearheaded concept and developed executive project dashboard template for effective execution of project plans, resource allocation and processes refinement
0-5 years of experience
Optimize drug development by providing expert scientific input
- Coordinate the planning and execution of multiple global Phase 3 Oncology trials
- Direct resources, projects, ongoing trials and new trial star-ups
- Manage study budgets and project timelines for global trials
- Selected and managed multiple vendors at the study and corporate levels
- Ensure studies are conducted within regulatory requirements, timeframes and budgets
- Develop clinical protocols and study materials
- Manage clinical operations team members
0-5 years of experience
- Handled a team of 4 people in clinical research department and assisted/analyzed their work to meet organization’s objectives and goals
- Directed an innovative Growth Hormone program for patients on dialysis suffering from complications related to diabetes
- Worked with DaVita dialysis and large patient vendors to facilitate care and treatment
- Managed budgets, staffing
- Provided training and support to the team members
- Responsible for recruiting for clinical research department
0-5 years of experience
- Project Manager for leading IVRS Services Provider to the Pharmaceutical Industry; responsible for the direct management of a minimum of five (5) studies concurrently
- Developed Project Specification and coordinate timelines for IVRS Platform design for pharmaceutical and biotech companies
- Designed user friendly IVRS Programs (randomization, medication assignment and diary)
- Coordinated client and internal validation (creation of validation plan, testing and reports for IVRS)
- Investigator Meeting presentations
- Oversaw and review data set releases for clients
- Managed studies with complex randomization schedules (multiple stratum), med management, diary calls, diary data collection
- Responsible for knowledge and adherence to 21 CFR PART 11
0-5 years of experience
Remotely manage all operations and conduct of global Phase III clinical trial(s) in Respiratory therapeutic area on high priority, large multi-center studies for sponsor company in 13 countries
- Manage team members, regional monitors, vendors and CRO partners to ensure coordination of task delivery and proper resolution or escalation of issues and performance.
- Identify and address all study, site and vendor related issues throughout all phases of trial management from study conception through reporting and submission.
- Develop and maintain study timelines and clinical trial budget and studies financial reconciliations/payments
- Ensure study inspection readiness and team member/partners adherence to protocol, sponsor SOPs and GCP/FDA regulations
- Ensure timeliness, quality and integrity of study data
0-5 years of experience
- Key responsibility of development, implementation and facilitation of clinical, and rater training programs for pharmaceutical clients.
- Provided primary support for coordination of e-learning and on-site training for investigators, clinical team and site personnel.
- Responsible for managing deployments, enhancements, defect resolution, eLearning integration and release management of Plateau LMS.
- Developed and managed project timelines, deliverables, and site communication materials.
- Worked in team environment and cross-functional activities related to patient recruitment and feasibility study projects.
- Evaluated project outcomes and prepare evaluative reports.
0-5 years of experience
- Managed delivery of domestic and international cardiovascular safety monitoring services
- Implemented project management plans and oversaw performance of internal project teams
- Responsible for development and accuracy of project budgets and forecasts
- Accountable for overall project team performance with respect to service delivery, quality and costs
0-5 years of experience
Management responsibilities for all aspects of Eclipsys/Allscripts full cycle delivery of multiple projects, i.e., activities related to the completion of this goal include responsibility for producing, monitoring, and reporting project status against project work plan as well as managing a project budget, resources, timelines, issues, and risks. Accountabilities and Responsibilities (90%+ national travel):
- Manage project scope, implementation plan, and resources requirements for Eclipsys project team and client project team
- Perform financial management, administration, and planning tasks that relate to client implementation projects.
- Manage tasks associated with successfully implementing solutions at the client site (A/R)
- Manage client relationships at the project and management level. Establish and maintain relationships with a diverse set of key clients, such as project office, I/T, clinical, and operational team leaders (A/R)
6-10 years of experience
Perform neurological and genetic assessments on patients coming through the
Muscular Dystrophy and ALS clinics.
- Manage multiple NIH-funded RO1 grants through the collection, compilation,
- Develop and maintain regulatory compliance protocols, databases, forms,
- Cultivate collaborations with investigators, local physicians, and clinics as well as procuring funds from non-profit foundations
- Supervise multiple team members; participated in strategic planning and implementation of policies and community initiatives
6-10 years of experience
Provide clinical and regulatory support for investigational diabetes device trials.
- Oversee monitoring of study conduct, documentation, and protocol compliance
- Oversee development of database, data entry and data verification
- Assist with data analysis and writing of study reports
- Provide primary technical support at study site
- Ensure compliance with ICH GCP Guidelines, state and federal regulations
- Assist with protocol, informed consent, and case report form development
0-5 years of experience
Responsible for the overall conduct of a trial, involved in the writing of protocols and amendments.
- Responsible for managing the regulatory IRB/EC submissions.
- Responsible for tracking patient enrollment.
- Responsible for ensuring sites both domestic and international followed all ICH-GCP/European guidelines.
- Responsible for assisting with the development of patient recruitment strategies and materials.
- Liaison between Sponsor and CRO organizations.
6-10 years of experience
- Current: Global Project Manager for a large Phase 3 study (23 countries and over 1000 subjects)
- Manage cross functional teams through complete project life cycle from Feasibility to Close out (Clinical, Regulatory, DM, Safety, Medical, Third Party Vendors) within scope of work
- Lead problem solving and resolution efforts to include management of risk, contingencies and issues.
- Manage project finances and timelines.
- Develop clinical reports and metrics including enrollment, and compliance metrics.
- Lead and present project summary data at client meetings, medical monitor meetings.
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Clinical Project Manager
Last edited by: Gabriela Barcenas, CONTENT STRATEGIST -
Gabriela Barcenas
CONTENT STRATEGISTGabriela is a Certified Professional Resume Writer (CPRW) and career adviser. With 10 years of digital media experience and five years of resume writing expertise, her publication history includes fashion, education, travel, social justice, equitable design and career advice.
