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Clinical Trial Manager Resume Samples
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0-5 years of experience
Managed a Phase IV, randomized clinical trial for the treatment of Degenerative Disc Disease and led study team planning for an IDE study.
- Acted in a lead role in building the clinical operations department, developing SOPs, work practices and implementing EDC and a CTMS.
- Responsible for all aspects of the clinical trial start-up including, identification, evaluation and management of CROs and vendors.
- Developed and manage the budget, timeline, monitoring schedule and all monitoring activities.
- Participated in site selection, qualification, monitoring and ongoing site/investigator support.
- Wrote and maintained Monitoring, Data Management and Communication Plans.
0-5 years of experience
Clinical Trials
- Successfully designed, implemented, managed and analyzed clinical trials for 8 biomarker assays, including assays for cTnI, HFABP and D-Dimer
- Worked as a lead member of a multifunctional team that includes 2 sites (U.S. and China) and 4 departments (regulatory affairs, R&D, QA/QC and manufacture) in applying for CFDA approval: 5 assays approved, and 3 additional pending
- Initiated, established and further developed partnerships with key opinion leaders(KOLs)
- Developed major research projects in collaboration with KOLs
0-5 years of experience
Provided leadership and operational management for a start-up biopharmaceutical company. Responsible for the management of clinical operations, hiring, related business development activities and served as a Project Manager for phase 1 and 2 hepatitis clinical trials.
- Managed and oversaw global clinical programs, CROs, and other selected vendors.
- Requested and reviewed RFPs from various outsourcing vendors and recommend selection to senior management based on cost analysis and capabilities.
- Provided oversight and management of investigator and site management issues.
- Facilitated global contractual and budget negotiations with investigators and vendors.
- Created or assisted in the development of study documents (protocols, case report forms, sample consent forms, study reference materials, etc).
- Supported business development activities that included due diligence meetings with potential partners, organized and represented the company at trade shows.
- Conducted oversight and booster visits to clinical sites (domestically and globally).
0-5 years of experience
Operationalized Phase III & IV clinical trials with responsibility for protocol designs, site and vendor selection, resulting in on-time delivery of clinical study results.
- Developed investigator relationships and initiated sites across 40 locations in US, Dominican Republic, Guatemala, and Panama, enabling rapid recruitment of the study.
- Coordinated, planned and presented at investigator and coordinator training sessions best practices and recruitment strategies.
- Conducted CRO Training.
- Performed investigator pre-study, initiation, and on-going site visits.
0-5 years of experience
Managed second-generation carotid embolic protection system and related stent device studies.
- Managed device startup activities for 510k clearance and associated safety studies including protocols, CRFs and multiple study- related document development.
- Managed PI and site criteria and selection and monitored study conduct.
- Hired and developed new project team.
0-5 years of experience
Lead 5 clinical trial teams (Phase II-V) and served as primary contact for all operational components of worldwide planning and execution.
- Managed all Clinical Trial Team (CTT) deliverables to completion including but not limited to site ready, enrollment, LPLV, and database lock. Worked to proactively identify issues and possible solutions. Worked to resolve and if necessary escalate issues to Clinical Program Operational Team (CPOT) Lead and/or functional area management, to insure awareness, facilitation of resolution to maintain or exceed trial level timelines.
- Communicated operations strategy to ensure clarity of scope for clinical trial team and assured that functional area leadership appropriately understood milestones and accountability.
- For each protocol, developed and ensured execution of the Operations Plan to include clinical trial strategy, risk assessment, mitigation plan, team membership, milestones/timeline, communication flow, and accountability.
- Managed multiple vendors including labs, central readers and IVRS and provided regular feedback to Relationship Management on their performance.
- Develop CTT shared objectives in concert with CTT members and direction from the Clinical Program Operational Team (CPOT) and routinely track progress against these objectives.
- Mentored junior staff and conducted departmental training; served as a Subject Matter Expert on Microsoft Project Scheduler and process development for implementation to cross functional area teams.
0-5 years of experience
Involved in study activities from start-up through NDA submission and successful approval of AFREZZA
- Oversaw clinical sites for the Phase III study in US and Europe; including but not limited to processing drug requests to ensure that all subjects received drug in a timely manner. Prepared protocol and protocol amendments. Obtained IRB approval and resolved site issues
- Oversaw Compassion Use Study in Europe to ensure that all supplies were received in a timely manner to meet the needs of the patients
- Performed Drug accountability at both site and sponsor level including replacement and return of expired/used drug supply
- Successfully implemented and managed subject payment system allowing subjects to receive payment after each completed visit. Subjects received payments via a debit/visa card in real time. Liaised with sites and trained on this system
- Successfully processed and entered all sites’ payments and information into new Clinical Trial Management System (CTMS) without interruption of sites receiving payments
- Reviewed study protocols and informed consent forms and amendments for internal consistency and compliance with ICH and FDA GCP regulations
- Co-monitored site qualification, initiation, interim monitoring visits and close out visits including training of sites at these visits
- Member of multiple Clinical Study Teams
0-5 years of experience
Increased patient enrollment by 50% through referral dinners, presentations, and major meeting involvement (TCT, TVT, Euro PCR, London Valves, Poland Heart Failure)
- Traveled extensively throughout Europe, South America, Canada, and USA providing referral programs, education, expertise, and case support
- Reviewed TEE, TTE, Fluoro, and relevant patient history to determine eligibility for trial requirements
- Involved in sterile procedure field and often used as first-assist in cath lab
- Developed procedural training protocol, echo training protocol, trained heart teams, and KOL’s globally
0-5 years of experience
Supervised the dermatology and photobiology departmental staff (20+ employees) to assure proper planning and timely project completion and controlling the utilization of resources within budgetary constraints.
- Served as direct report for Project Managers and Clinical Research Associates in dermatology and photobiology departments.
- Represented the company at professional and trade association meetings.
- Assessed staffing needs, assigned projects and managed daily operations of the dermatology, photobiology and medical writing departments, including conducting performance and salary reviews and coordinating training programs and associated documentation.
- Coordinated selection and scheduling of off-site Investigators.
- Prepared clinical study protocols and reports, abstracts, manuscripts, poster presentations, Standard Operating Procedures (SOPs), and other clinical documents.
- Performed, interpreted and reported statistical analysis for the determination of significance and/or correlation.
- Created tables, figures, graphs and summaries of study data.
- Advised client representatives of marketing statements supported by study data.
0-5 years of experience
Planned, managed, and executed numerous global adult (Phase 2-3) and pediatric (Phase I) studies in the CV, ID and Neuroscience therapeutic areas. Experience in effectively leading study teams and staying on target.
- Managed country feasibility /site selection and all study start-up activities, created and drove study timelines to achieve major milestones.
- Ensured regulatory compliance and GCP adherence, proactively identified risks to delivery or quality and ensured appropriate risk mitigation plans were in place; implemented corrective actions for major issues.
- Coordinate, facilitate and present at Investigator Meetings, Regional Study Manager (RSM) and Site Manager (SM) meetings.
- Provide training to RSM/CRAs, developed operational tools, and ensured the approved standard processes, tools, and procedures were used globally.
- Obtained input on study management from functional areas and regions regarding startup through database lock.
- Drove development of study database and coordinated with Data Management to assure data capture and cleaning were acceptable with regional study timelines. Coordinated data management activities for an on-time database lock.
- Selected and managed central vendors, facilitated monitoring activities from pre-study to study close-out, and participated in global initiatives to identify efficiencies in the regions start-up process.
- Provided input on financial forecasts, managed study budget including the review/approval of study payments to sites/vendors,
- Created monitoring/recruitment plans, performed trip report review, tracked study enrollment and performed on-going recruitment activities for extremely difficult indication to enroll.
- Complete oversight of central labs and contract research organizations, and provided progress reports to senior management.
0-5 years of experience
- Managed a Phase II, multi-center, vaccine study for advanced stage breast cancer
- Ensured the successful implementation of study-related activities including site management and monitoring.
- Collaborated with other study team members in the completion and delivery of study objectives.
- Managed and mentored CRAs and Project Assistants and provided study specific training.
- Served as primary contact with study partner and provided timely report on study progress.
0-5 years of experience
Managed a new trial duties included: Study Start-up Activities: conducted site feasibility, intricately involved in investigator selection, acquisition of essential documents, negotiated budgets and contracts with sites, chaired and executed team meetings, developed and presented the kick off meeting, managed all aspects but not limited to the vendor contract, scope of work negotiations, and HIPPA agreements).
- Study execution: Managed the CRA team and served as main point of contact for study logistics and related questions including subject eligibility questions.
- Managed study vendors and sites to ensure that key study milestones were met. E.g. Laboratory supplies, reports, drug manufacturing packaging/labeling, supply and distribution, IVRS set up and execution, monitoring time lines, budgets and contracts. By chairing weekly sponsor/project management meetings and teleconferences
- Performed periodic review and revision of departmental policies and SOPs to assure compliance with corporate policies, Good Clinical Practice procedures (GCPs), and ensured compliance with the regulations of local and regional governmental agencies. Maintained professional skills by keeping abreast of literature, attending conferences, courses and meetings/symposia.
- Also responsible for supporting, the Director of Clinical operations on all aspects of clinical trial(s), such as managing interactions with Global Clinical Development Operations, medical monitors, program level activities as assigned.
0-5 years of experience
Monitored and managed multiple, simultaneous studies Phase II, III.
- Oversaw reorganization reducing headcount by half.
- Managed monitor and contract staff during downsizing.
- Led the key corporate program which resulted in an approved drug.
0-5 years of experience
- Audit study files and coordinated directly with the QA department for two women’s Health programs in preparation for FDA Sponsor Inspection
- Organized, coordinated and led cross functional team in mock inspections for same
- Participated in FDA Sponsor inspection assisting in preparing responses to questions from Inspectors
- Act as in-house point person for sites being audited by FDA
- Address and resolve audit findings
- Assist other project teams with trip report review and payments
0-5 years of experience
- Partnered with Medical Directors and clinical team to strategize and create Clinical Development Plans.
- Produced trial cost projections and timelines.
- Prepared and reviewed clinical sections of the Investigator’s Brochure, annual IND, and Clinical Trial Reports.
- Developed and maintained departmental and project budgets to ensure programs complied with prescribed scheduling, staffing, and performance requirements.
- Supervised and provided guidance to junior personnel.
- Participated in the selection of Contract Research Organizations and served as their primary contact.
- Managed and monitored clinical investigative and processing sites.
0-5 years of experience
Clinical project leader responsible for writing clinical protocols and managing clinical trials.
- Coordinated CROs, contracted vendors, and investigational sites for proper study conduct.
- Coordinated and prepare materials for an IND submission and assist with NDA preparation.
- Developed, planned, and managed project budgets, timelines, and clinical plans.
0-5 years of experience
- Provided oversight and management of international cardiovascular trials in the Americas, Asia, Africa, and Eastern and Western Europe to ensure overall study quality and adherence to trial timelines
- Collected, tracked, analyzed, and reported trial information to executive management
- Provided oversight of trial audit/inspection findings/responses, both internal and external
- Provided oversight of and preparation for FDA pre-approval inspections (PAI).
- Selected and managed Contract Research Organizations and vendors
0-5 years of experience
Managed multiple protocols for Phases I, II, and IV
- Provided monthly trial status (budget, timeline, recruitment metrics, vendor performance metrics) presentation to upper management
- Collaborated with Medical Liaisons to ensure timely start up, site and budgetary support of investigator initiated trials.
- Selected and managed vendors to ensure clinical projects are performed effectively and in accordance with GCP and all SOPs
- Responsible for the management of study budget
- Developed and finalized study protocol amendments
- Identified and addressed trends and issues during progress of study
- Assisted with the development of study CRFs
- Ensure payments were made to vendors and investigator sites for the duration of a study, ensure study sites are properly monitored, and ensure adequate drug supplies were available
0-5 years of experience
Coordinate project start-up, project maintenance, and project close-out activities
- Maintain ongoing Sponsor contact for project-specific issues
- Track patient and CRF status, safety issues, and timelines Serve as primary contact for all protocol interpretations and logistical project-related issues
- Provide oversight for CRAs and Project Coordinators on project team
- Interpret contract-related issues and coordinate Medpace activities according to current scope, communicating change in scope to Sponsor Clinical team and Medpace Contract Manager
- Provide input for study protocol, edit check specifications, data analysis plan, MDRGs, data clean-up results and analysis, and final study report, when applicable
0-5 years of experience
- Six-month contract with [company name] International Inc. to accomplish planning activities for a complex multicenter Phase III Pilot study in varicose veins to test key endpoints and procedures thus de-risk phase III for potential partners.
- Co-authored a complicated protocol testing a photographic endpoint and piloting an injectable sham procedure planned for use in phase III device and drug study. Also provided epidemiology expertise in the development of a questionnaire validation trial.
- Assisted with development of a difficult protocol design requiring extensive planning and effort from the project team.
- Assisted with coordination of external contractors to budget negotiations, timelines, and go/no go milestones.
- Coordinated the evaluation and selection of clinical sites and a central IRB.
0-5 years of experience
Monitors and tracks clinical studies (oncology, neurology), provide periodic / regular updates to the team.
- Enter data and tracks study progress in CTMS, monitors clinical trials through IMPACT software.
- Assist with the clinical team in the medical review of reportable event data, ensures that all information needed to support a sound medical case is obtained, including coordination of company causality assessment.
- Generate safety queries to the study sites to resolve gaps and discrepancies in the data related to reportable events.
- Coordinate and/or conduct site selection visits to determine whether a given site is qualified for participation in a clinical trial (including physical plant and staff capabilities) and provide written summary of findings
- Coordinate and/or conduct site initiation visits, interim monitoring visits and close-out visits to ensure quality patient recruitment and site conformance to GCP and study protocols
- Ensure the collection and review of all source documentation and identify and resolve discrepancies in a timely manner
- Assist sites in the compilation and submission of site-specific Ethics Committee (i.e., IRB) documents
0-5 years of experience
- Lead the execution of investigator and sponsor initiated oncology trials for the research team
- Collected, completed, and entered data onto case report forms and electronic data capture systems
- Educated research nurses and study site research staff on protocols, protocol modifications/amendments and specifications
- Reviewed source documentation and queried for missing documentation
- Developed case report forms (CRFs) for investigator initiated trials
- Resolved queries of CRF data with study site personnel
- Initiated improvements to enhance the efficiency and quality of work performed on assigned projects
- Provided preliminary analysis of clinical trial data
- Prepared and processed serious adverse events to study sponsors and IRB
- Expanded knowledge of FDA guidelines and Good Clinical Practices
0-5 years of experience
Responsible for leading program level strategy and execution for COPD study-Global Phase III and IV.
- Manage CRO (Senior CTLs, CTL, CTA, Country Operations and Monitors) as direct reports.
- Responsible for 150+ global sites (PSV, SIV, IRB submission, IMP shipment, Regulatory approval) for 1100 plus subjects enrollment
- Monitor United Kingdom, Italy and France sites from study start-up to closeout activities. Implement and develop plans for efficient and rational decision-making using Monitor Plan, Risk Plan, Patient Recruitment and Retention Plan, Data Management Plan, Safety Plan and Site Validation Plan.
- Track 150 + global sites documentation (lab reports, trial initiation forms, safety reports, monitoring logs and reports, Investigator Meeting participation and clinical documentation.
- Liaise with contracted companies to disseminate protocol information using well-built communication, interpersonal, organizational, and presentation skills.
- Prepare and manage internal/external meetings as needed to ensure that all timelines are met.
- Ensure transparency and open-communication between CROs, Vendor and Sponsor during trial conduct.
- Wrote 6 + CAPAs from Audit reports for Asia-Pacific sites.
0-5 years of experience
- Manage clinical trial activities on 100+ site, 1100 patient, $36 million dollar Phase 3 clinical trial in diabetes with focus on insulin treated type 1 and type 2 diabetes mellitus patients
- Planned and executed trial-level project management activities for assigned studies including trial-level timelines, risk assessment, mitigation plans, budgeting, site start up, and other aspects of trial-level project management
- Lead multifunctional study team and managed relationships while serving as the focal point of communication between internal and external clinical research partners
- Design, develop, and execute clinical trial protocols in a multifunctional/collaborative environment with rapidly shifting priorities
- Lead document reviews and project team input consolidation
- Interact and collaborate with thought leaders on PK analysis, DSMB, statistical considerations, regulatory strategy
- Train investigators, site, and other study personnel on study protocol and procedures
- Partnered with Sourcing groups, Procurement, and study team to review sourcing alternatives, develop sourcing tools, and provide necessary study specifications in order to obtain reliable study costs, staffing strategy, and timeline projections.
- Responsible for CRO oversight and management from project initiation to close out.
0-5 years of experience
Served as primary contact for PD on cross functional teams for protocol execution.
- Oversee forecasting of clinical /non-clinical supplies.
- Ensured accurate tracking and reporting of study metrics.
- Provided vendor management, including negotiation of budgets and issue resolution.
- Ensured trial adherence to ICH/GCP/local regulations.
6-10 years of experience
- Managed vendors
- Tracked and reported enrollment, assisted with the development of accrual plans
- Ensured preparation of study-specific training materials for project team; conducted trainings
- Helped to Create, edit and finalized study related documents
- Monitor study timelines, patient recruitment, retention and data cleaning
- Create and present study information at Investigator Meetings
- Lead and manage functional team meetings
0-5 years of experience
Reported and evaluated data according to NCI and FDA regulations and guidelines.
- Queried sites regarding errors, omissions or inconsistencies in data and adverse events.
- Analyzed toxicity, response, follow-up, and survival data.
- Completed field/configuration edit checks/validation for study build in Medidata RAVE.
0-5 years of experience
Conduct pre-study/qualification, initiation, and interim monitoring visits to ensure quality and timely study data
- Collect, track, maintain and coordinate required regulatory documents in accordance with Standard Operating Procedures (SOP), GCP and ICH Guidelines
- Manage clinical trial activities and resolve site/subject related issues as expeditiously as possible
- Track study progress including start-up activities, patient enrollment, site monitoring, and study closeout activities
- Coordinate study communication and distribute study materials such as CRFs, study protocols and amendments, periodic reports and newsletters
- Supervise work of Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs) and assist in orientation/training of new staff members
- Monitor investigator compliance for the reporting of Adverse Events and Serious Adverse Events to Sponsors and IRBs
0-5 years of experience
- Answered phones
- Scheduled patient appointments
- Contacted Pharmaceutical companies via email/fax
- Handled Budgets and Regulatory Documents
- Assisted physician with patients
- Maintained the Accounting (Bookkeeping and Accounts Payable)
Clinical Trial Manager Duties and Responsibilities
Clinical trial managers’ regular tasks depend on factors such as the size of their employer, the type of trial they are managing, and their position within the company. Despite these factors, most clinical trial managers usually perform the following tasks:
Manage Clinical Trials Managing clinical trials for private physicians, drug companies, government agencies, and academic institutions is a major part of a clinical trial manager’s job. They oversee trials, ensuring they are executed correctly and follow the correct protocol. They might report issues or problems to a physician or director in charge of the trial.
Recruit Participants (Study Subjects) Every clinical trial needs willing participants. Often, for scientific and research purposes, participants must meet certain criteria before they are selected. Clinical trial managers often help screen potential study subjects and provide them with information before the actual trial.
Monitor Trial Progress When conducting a study, it is important to keep track of every development. Clinical trial managers are usually responsible for monitoring the progress of study subjects and the overall trial. They are often given certain diagnostic tools to ensure the trial is progressing as planned.
Contact Supervisors or Scientists Clinical trial managers often have close ties the scientists and physicians responsible for the trial. They are expected to update these individuals and provide them with important details regarding the trials. Clinical trial managers may have regular meetings with scientists, researchers, or physicians.
Collect Data Many clinical trials require interviews with study subjects. The questions asked during these interviews are highly important and can have a major impact on the outcome of the study. Clinical trial managers are often tasked with collecting data from study subjects and presenting it to the appropriate party.
Clinical Trial Manager Skills and Qualifications
Clinical trial managers should have a strong interest in science, pharmaceuticals, or medicine and at least a bachelor’s degree. The certifications and educational requirements to become a clinical trial manager vary from company to company. However, most companies and medical establishments look for the following traits in clinical trial managers:
- Scientific or medical knowledge – clinical trial managers do not have to be actual doctors, pharmacists, or scientists, but they must possess basic knowledge in these fields. They should have a firm understanding of elementary science principles in biochemistry, pharmacology, and chemistry so they can make decisions without direct assistance from researchers
- Research background – conducting clinical trials requires an in-depth knowledge of the research process. Clinical trial managers should know how to set up trials, collect and interpret the data
- Managerial experience – clinical trial managers should be capable of handling large and complex trials, other clinical trial employees, multiple participants, and large amounts of data
- Communication – to actively communicate the requirements and steps of the trial to the participants and the employees they manage
- Analytical skills – to collect and interpret data, noting important patterns or outcomes that should be brought to the attention of those responsible for the trial
Clinical Trial Manager Education and Training
Most companies require clinical trial managers to have at least a bachelor’s degree in a science, engineering, or a mathematical field. To obtain a bachelor’s, most individuals enroll in a four-year college or university and take courses in biology, chemistry, biochemistry, statistics, writing, and genetics. For some clinical trials, a master’s degree and a supervisory background are required. Clinical trial managers usually receive some on-the-job-training from more experienced employees.
Clinical Trial Manager Salary and Outlook
The salaries of clinical trial managers largely depend on their place of employment and years of experience. However, in the United States, clinical trial managers earn an annual median salary of $97,870. Clinical trial managers in the top 10 percent earn more than $130,679 annually, while those in the 10th percentile earn less than $64,866 annually. Individuals in this profession typically have access to employment benefits such as health insurance, retirement, paid time-off, and bonuses based on longevity and performance. The employment rate for clinical trial managers is expected to grow by 17 percent between 2014 and 2024. This rate is much higher than the national average of 7 percent for all professionals, and the increase is attributed to the growth of the pharmaceutical, medical, and private research sectors.
Helpful Resources
Does the prospect of becoming a clinical trial manager sound enticing? Let the following resources help you land your dream job:
Society of Clinical Research Associates (SOCRA) – SOCRA is an organization dedicated to clinical research associates. It offers a variety of educational opportunities, such as certification courses, seminars, and speaking events. Those interested in the field can also apply for membership or look up a local chapter on the organization’s website.
Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators – Anyone looking for a manual geared towards individuals looking to enter the clinical research field should take a look at this book. It provides tips for recruiting patients and coordinating studies, as well as an entire chapter dedicated solely to simplifying government and industry regulations. Written by leading medical researcher Judy Stone, MD, Conducting Clinical Research demystifies the role of a clinical trial manager.
Business Administration for Clinical Trials – As a manager, you will be responsible for handling a variety of administrative duties in addition to coordinating clinical trials. The product of a partnership between R. Jennifer Cavalieri and Mark E. Rupp MD, Business Administration for Clinical Trials explores the business and financial aspects of working in the clinical research industry.
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Last edited by: Gabriela Barcenas, CPRW, Content Writer II -
Gabriela Barcenas
CPRW, Content Writer IIGabriela 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.
