Clinical Project Manager Resume Samples - Page 2

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Clinical Project Managers usually work for pharmaceutical companies where they coordinate assigned clinical trials and complete tasks such as ensuring that projects are completed on time and within budget, creating timelines for each project, preparing documents, reviewing project tasks, handling budgets, and ensuring compliance with industry procedures and regulations. The ideal candidate should highlight in their resume thorough knowledge of clinical trial processes and medical terminology, and general business skills, such as communication, time management, and computer competencies. The most successful sample resumes showcase a Bachelor's or a Master's Degree in life sciences.

11

Clinical Project Manager

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
Candidate Info
4
years in
workforce
2
years
at this job
BA
Business Administration
12

Clinical Project Manager

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
Candidate Info
11
years in
workforce
5
years
at this job
AAS
Associate of Applied Science
13

Clinical Project Manager

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
Candidate Info
9
years in
workforce
1
year
at this job
BA
English
14

Clinical Project Manager

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
Candidate Info
16
years in
workforce
2
years
at this job
BA
English And Biological Studies
15

Assistant Clinical Project Manager

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
Candidate Info
6
years in
workforce
10
months
at this job
BA
Biology
MA
Healthcare Policy
MS
Organizational Leadership
16

Clinical Project Manager

  • 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
Candidate Info
8
years in
workforce
6
months
at this job
BA
Psychology
17

Clinical Project Manager

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
Candidate Info
5
years in
workforce
1
year
at this job
BA
Bachelor of Arts
18

Clinical Project Manager

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.
Candidate Info
7
years in
workforce
1
year
at this job
MA
Sociology
19

Clinical Project Manager

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.
Candidate Info
1
year in
workforce
1
year
at this job
MS
Medical Informatics
Doctor Of Veterinary Medicine
20

Clinical Project Manager - US Army Warrior Transition Command

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.
Candidate Info
12
years in
workforce
2
years
at this job
C
Project Management
BS
Nursing
MS
Nursing

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