Clinical Study Manager Resume Samples

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Clinical Study Managers coordinate operations related to clinical studies and complete tasks such as planning clinical trials, reviewing study documents, supervising clinical teams, collaborating with other departments, allocating resources, and recruiting staff. Based on our most successful example resumes for Clinical Study Managers, the ideal candidate demonstrates clinical trials expertise, leadership, project management skills, time management, teamwork, and analytical thinking. Employers select resumes displaying a degree in natural sciences and experience in the pharmaceutical or biotechnology industry.

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1

Clinical Study Manager

Directed or personally executed study conduct and close-out activities for 22 site, US phase II trial as key member of small internal team and consultants for young biotechnology company.

  • Identified, oversaw and collaborated with various vendors that delivered site management and monitoring, central image reading, recruitment and public relations for phase III trial to ensure compliance to protocol and GCP guidelines.
  • Compiled and communicated various study metric and summary reports to senior management and company board of directors.
  • Key contributor or developer of all study documents including protocol, ICD template, CRFs and data collection tools, CRO oversight plan, site training materials.
  • Oversaw site management and monitoring vendor to complete feasibility and selection and start-up of over 90 study sites for US based phase III trial.
  • Developed study level recruitment materials and reviewed all site specific materials to align with trial and company messaging.
Candidate Info
14
years in
workforce
4
years
at this job
BS
Health Care Administration
BS
Nursing
2

Clinical Study Manager / Consultant

Reviewed protocols and advised Clinical Research Scientist regarding logistics involved in the conduct of the study for pain management trials in 15 centers within US.

  • Developed informed consent, case report forms with completion guidelines, source documents and monitoring plan for reference ensuring study trial procedures and processes were followed.
  • Supported regional CRAs in successfully monitoring clinical trials by reviewing and approving site reports, co-monitoring, conducting weekly meetings, resolving individual and site issues and maintaining training records.
  • Conducted study start- up for two pain management trials to include recruitment of 30 investigational sites for each trial.
  • Coordinated two investigator meetings in 8-month period.
Candidate Info
9
years in
workforce
1
year
at this job
BA
Biological Science
3

Clinical Study Manager

Managed up to 4 clinical studies simultaneously. Accountable for Study Start up, Conduct, and Study Closure. Organized and presented Investigator meetings. Participated in Global studies as an USA affiliate.

  • Provided leadership for clinical research studies, ensuring timelines and deliverables met or exceeded standards.
  • Assisted with protocol and amendment review, reducing corrections.
  • Conducted 2 phase 1 investigator meetings. Participated in 1 phase IV investigator meeting, which included vendors and global personnel.
  • Developed good rapport with PIs and SCs and ensured 24-hour response time. Kept enrollment open during plant closures, allowing for continuous communication. Delivered exceptional customer service, especially with phase 1 studies.
  • Selected to pilot 4 new programs and processes in the U.S. Identified obstacles, contributed to solutions, shared findings for global rollout and revisited issues as needed.
  • Managed financials for each study including: budget negotiations, forecasting, assumptions, invoices and reconciliation. Selected vendor when applicable. Managed CROs in phase IV studies.
  • Streamlined supported studies by closing 49 out of 84, decreasing costs and resources. Received overpayments from 4 sites.
  • Orchestrated an Oncology department site selection database. Team members entered the site's area of expertise, past study information and future study interests. This information decreased study start up timelines
  • Received Employee Recognition Award for contributions in 2008 and 2012: 2008 Team Work Recognition Award. Worked on Nephrology Studies. Helped DM, MD and Clinical Operations resolve issues, allowing for DBL 1 day early.
Candidate Info
24
years in
workforce
5
years
at this job
HS
Graduate
4

Clinical Study Manager, US Clinical Field Operations

Managed daily operational activities associated with 19 Phase 1-4 clinical studies, including study start-up, interim conduct and closeout activities

  • Ensured high performance and efficiency of the study team by providing ongoing study-specific training of the Regional CRAs and other study staff
  • Interacted with and built professional and collaborative relationships with all study personnel (investigators, study coordinators, pharmacists, etc)
  • Developed timelines for site initiation, interim monitoring, and closeout visits. Monitored progress and worked with Regional Managers to ensure adherence to timelines
Candidate Info
11
years in
workforce
2
years
at this job
BS
Medical Technology
5

Clinical Study Manager/manager, Clinical Research

Manages Clinical Operations, including 3 direct reports. Oversees clinical trials from development to closeout, with a focus on surgical and wound care applications of a Section 361 tissue product. Responsible for providing guidance to all sites on study administration. Maintains regulatory filing and reporting. Creates and manages all study documents (protocol, ICF, contracts) and data tools including CRFs and study database. Manager of clinical trials for industry-sponsored trials reporting directly to Chief Medical Officer.

  • Promoted to department manager in 2015.
  • Organizes and oversees internal Clinical Events Committee
  • Grew clinical department from running 3 studies at 3 sites to 10 studies at 50+ sites in 2 years, wrote and managed all clinical documents for these studies
  • Builds departmental infrastructure with the goal of FDA compliance, including writing SOPs
Candidate Info
13
years in
workforce
4
years
at this job
BSN
Nursing
BS
Studio Art, Social Science
MA
Forensic Anthropoloogy
6

Clinical Study Manager

Acted as the primary contact between [company name] and pharmaceutical company representatives in order to conduct all aspects of a successful Phase I clinical trial (end to end project management).

  • Obtained study protocol from the pharmaceutical company and broke it down to its key aspects.
  • Partnered with departments across the company to implement study protocol key aspects internally.
  • Ensured conduct of the clinical trial was 100% accurate and in compliance with strict Food and Drug Administration guidelines.
  • Collaborated with physicians and nurses in order to make sound decisions quickly regarding aspects of patient health.
Candidate Info
10
years in
workforce
1
year
at this job
BA
Sociology
7

Clinical Study Manager

Managed and executed clinical trials in oral care, microbiology and dermatology for major pharmaceutical companies according to both company and client driven protocols, ensuring compliance to both GCP and ICH-GCP guidelines.

  • Directly supervised clinical study coordinators and laboratory technicians implementing clinical trials, microbiology validation tests, and conducted site initiation meetings with clients and monitors.
  • Implemented clinical SOPs, GCPs, as well as design of GLP guidelines.
  • Proficient in protocol design and writing as well as design of source documents and case report forms.
  • Experienced in preparation and review of clinical summary reports and final reports.
  • Excellent knowledge of the IRB process and regulatory compliance issues.
  • Assisted business development in creation of proposals for clients and in formulation of study budgets streamlined to maximize profitability.
Candidate Info
12
years in
workforce
1
year
at this job
BA
Biology
PhD
Microbiology
Microbiology
8

Senior Clinical Study Manager

Wrote clinical portion of Product Development Plan; presented to CEO and Senior VPs

  • Wrote Phase III Dyslipidemia protocols, participated in discussion of protocol design with FDA, updated Investigators Brochures, Safety reports, managed conduct of study, selected sites, prepared and negotiated budgets, CRFs, drug supply, informed consents/HIPAA, created study aids, planned Investigators' Meeting
  • Coordinated Electronic Data Capture for studies
  • Hired, trained and managed 7 direct reports
  • Oversaw 22 regional monitors
Candidate Info
14
years in
workforce
1
month
at this job
C
Marketing
BA
Biological Sciences
Immunology, Pharmacology, Statistics
9

Clinical Study Manager

Managed a clinical research study to identify acute cases of [company name] infection in high risk populations in Abuja, Nigeria

  • Prepared and maintained all study protocols and Institutional Review Board (IRB) regulatory documents
  • Trained study staff on all aspects of the [company name] research protocol including community recruitment for [company name] education and testing, [company name] counseling and testing and enrollment of [company name] positive patients in PEPFAR [company name] treatment programs
  • Monitored and evaluated all study site activities such as study enrollment, data collection, data entry, data management, [company name] counseling, serology and PCR testing
  • Supervised all laboratory activities in [company name] serology and molecular testing (Polymerase Chain Reaction (PCR))
  • Prepared study progress reports, documented implementation barriers and made recommendations for all study areas
  • Analyzed study data for abstracts, manuscripts and grants
Candidate Info
7
years in
workforce
3
years
at this job
PhD
Epidemiology
Microbiology
Epidemiology And Biostatistics
10

Clinical Study Manager for Biocryst Pharmaceuticals

Clinical study manager role with operational responsibilities for early phase studies in the area of hematological oncology and the management of several gout studies in early development. Held a supportive role in the development program, ensured that study timelines were achieved, worked with data monitoring committees and was responsible for all financial aspects related to the ongoing studies.

  • Operational oversight and management of CROs and other selected vendors.
  • Creation of yearly project budgets and ensured completion of studies within budget.
  • Reviewed and approved all pertinent study related materials.
  • Created RFPs, reviewed SOWs, and participated in vendor selection activities.
  • Facilitated the clinical study report process from shell development through publishing.
  • Participated in the development of recruitment strategies to ensure milestones were met.
  • Recommended and successfully transitioned a study from a CRO back in-house for significant operational cost savings.
Candidate Info
20
years in
workforce
5
years
at this job
BS
Bachelor of Science

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