Clinical Trial Manager Resume Samples

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Clinical Trial Managers coordinate clinical development programs. Essential duties listed on a Clinical Trial Manager resume sample are monitoring staff performance, reviewing clinical data, making sure study protocols are being followed, allocating budgets, and liaising with study vendors. Based on our collection of example resumes, Clinical Trial Managers should demonstrate the following qualifications: pharmaceutical experience, networking, leadership, the ability to work under pressure, teamwork, and computer competences. Eligible candidates hold at least a Bachelor’s Degree in pharmacy or biotechnologies.

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1

Clinical Trial Manager

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.
Candidate Info
14
years in
workforce
11
months
at this job
BA
Liberal Arts
MA
Master of Arts
2

Clinical Trial Manager

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
Candidate Info
14
years in
workforce
2
years
at this job
BA
Medicine
PhD
Biological & Biomedical Sciences
3

Global Clinical Trial Manager

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).
Candidate Info
13
years in
workforce
1
year
at this job
BS
Bachelor of Science
4

Clinical Trial Manager - R&d

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.
Candidate Info
8
years in
workforce
2
years
at this job
BA
Bachelor of Arts
MA
Master of Arts
5

Clinical Trial Manager

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.
Candidate Info
15
years in
workforce
2
years
at this job
MBA
Master of Business Administration
Bs, Education / Life Sciences
6

Clinical Trial Manager, Senior Project Manager

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.
Candidate Info
15
years in
workforce
2
years
at this job
BA
English
BA
Economics
MA
Education / Teacher Certification
7

Associate Clinical Trial Manager

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
Candidate Info
15
years in
workforce
4
years
at this job
AS
Science
Health Care Administration
8

Global Clinical Trial Manager

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
Candidate Info
5
years in
workforce
6
months
at this job
BS
Health Administration
9

Dermatological Clinical Trial Manager / Director of Medical Writing

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.
Candidate Info
9
years in
workforce
1
year
at this job
MS
Biochemistry And Molecular Biology
10

Senior Clinical Trial Manager

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.
Candidate Info
12
years in
workforce
4
years
at this job
AS
Associate of Science
BS
Nursing
MS
Clinical Research Organization & Management

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