CLINICAL PROJECT MANAGER SKILLS, EXPERIENCE, AND JOB REQUIREMENTS

Updated: Nov 22, 2024 - The Clinical Project Manager possesses direct project management experience in medical device trials, with a focus on cardiovascular therapeutic areas for both pre-market and post-market stages. Skilled in verbal and written communications, the manager excels in hosting large project meetings, drafting professional communications without oversight, and understanding clinical trial regulations across US and international settings. Demonstrated leadership in driving company goals within highly matrixed and geographically diverse business environments showcases the manager's ability to effectively manage complex projects with meticulous attention to detail.

Essential Hard and Soft Skills for a Standout Clinical Project Manager Resume
  • Clinical Trial Management
  • Regulatory Compliance
  • Data Analysis
  • Budget Management
  • Risk Management
  • Biostatistics
  • Medical Writing
  • Pharmacovigilance
  • Protocol Development
  • Project Scheduling
  • Leadership
  • Communication
  • Problem Solving
  • Adaptability
  • Team Collaboration
  • Attention to Detail
  • Conflict Resolution
  • Time Management
  • Empathy
  • Decision Making

Summary of Clinical Project Manager Knowledge and Qualifications on Resume

1. BA in Biomedical Science with 7 years of Experience

  • Prior relevant experience including project management experience or equivalent combination of education, training and experience.
  • Good understanding of project financials including experience managing, contractual obligations and implications. 
  • Knowledge of clinical trials and broad protocol
  • Strong written and verbal communication skills including good command of English language.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients 
  • Experience in managing clinical studies or equivalent product development programs. 
  • Experience in in vitro diagnostic/medical device-related studies
  • Knowledge of Good Clinical Practice and regulations governing in vitro diagnostics/medical devices
  • Advanced skills in project planning and management, judgment, decision-making, and problem-solving.
  • Working knowledge of new product development methodologies

2. BA in Clinical Research with 8 years of Experience

  • Experience in clinical research with experience in study management.
  • Experience in management of CROs, vendors and consultants.
  • Documented training, knowledge and application of current FDA Regulations, and ICH-GCP guidelines for clinical trials
  • Proficient written and verbal communication skills.
  • Strong problem-solving, leadership and organizational skills
  • Ability to collaborate effectively with the study team, cross-functional team members and external partners (including investigator and site staff) using collaborative negotiation skills.
  • Therapeutic (oncology) or medical knowledge
  • Ability to be creative in achieving objectives while ensuring compliance with regulatory requirements and policies
  • Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Projects.

3. BA in Public Health with 5 years of Experience

  • Work experience in clinical research and/or clinical trial management.
  • Strong background in scientific and clinical methods.
  • Must have CCRP® or CCRA® credential
  • Evidence of training in ICH GCP and ISO 14155.
  • Excellent written, verbal, computer, and organizational skills.
  • Able to consistently present a professional and personable demeanor in phone, written, and face-to-face communications.
  • Proven ability to manage multiple projects and meet deadlines.
  • Proven ability to communicate and work constructively with colleagues to establish and achieve mutual goals.
  • Must be able to perform the essential functions of the job, with or without reasonable accommodations
  • Limited exposure to hazardous chemicals used in the manufacture of the product.

4. BA in Nursing with 9 years of Experience

  • Strong background in medical or biological sciences or a discipline associated with clinical research.
  • An advanced degree in Science or Engineering, and PMP certification
  • Extensive experience in the biotechnology or pharmaceutical industry (or where relevant a biomedical research organization).
  • In-depth knowledge of drug research, development, and manufacturing processes of pharmaceuticals (CMC, non-clinical, clinical, and regulatory).
  • Broad experience as a project manager leading cross-functional project teams in a matrixed, global environment, including those with complex technical, geographic, and/or regulatory elements.
  • Demonstrated experience in leading cross-functional teams and delivering projects to meet business objectives on time, within budget and with quality.
  • The ability to participate in the learning and development of junior Project Management staff and provide mentoring and coaching.
  • Proficient in the use of Project Management processes and tools (e.g. Microsoft Project).
  • Ability to work effectively, and independently with multi-level teams
  • The ability to manage multiple projects and work in a fast-paced and changing environment.

5. BA in Pharmacology with 10 years of Experience

  • Experience working in human clinical research
  • Experience/Knowledge in IVD products, and Clinical Laboratory processes
  • Experience in Microbiology, Virology, Immunology, Biochemistry, Molecular Biology, Hematology, Chemistry, or any other aspect of clinical laboratory medicine, In Vitro Diagnostics, Specimen collection, and processing
  • Clinical laboratory or clinical research experience, experience in a medical device/lVD company
  • Familiarity with CLSI guidelines and other standards
  • Background in Infectious Diseases and/or Cancer
  • Biospecimen acquisition and prospective sample collection protocols
  • Project management experience using MS Project and/or recent proven success within a BD product development core/extended team (with PMP Certification)
  • Knowledge of clinical trial concepts and practices, including international clinical research guidelines.
  • The ability to work effectively in a virtual environment.

6. BA in Pharmacy with 7 years of Experience

  • Experience in managing international clinical trials
  • Extensive knowledge of GCP guidelines, MDR, and ISO 14155
  • Fluent in English (and/or French practice)
  • Strong work ethic and daily act with integrity, honesty and fairness
  • A thoughtful team player, looking to make your colleagues successful
  • Experience in the literature review, and scientific publication
  • Experience in software as a medical device
  • On-site monitoring working experience
  • Self-driven, able to work independently as well as on cross-functional teams
  • Excellent planning and organizing skills
  • Pro-active and problem-solving attitude with strong prioritization skills
  • Excellent communication, interpersonal, and networking skills
  • A good working knowledge of IT agile (Notions, Slack, DropBox, etc. as daily tools)

7. BA in Health Science with 6 years of Experience

  • Good Time Management and organizational skills
  • A team player with the ability to work independently and autonomously
  • Excellent leadership and team management skills with Confidentiality
  • Profound knowledge of Microsoft Office (Word, Excel, PowerPoint and Outlook) and Internet use
  • Knowledge of good clinical practices and standard operating procedures
  • Relevant experience in project management within the Pharmaceutical Clinical Trial sector
  • Working experience in monitoring sites. 
  • Experience in overseeing CRAs including reviewing monitoring visit reports, training CRAs and co-monitoring
  • Ability to use judgment to effectively solve problems
  • High degree of initiative and self-motivation with a strong sense of accountability
  • Excellent communication skills in English both oral and written.

8. BA in Biochemistry with 9 years of Experience

  • Proven clinical trial working experience with clinical project management experience
  • Ophthalmology working experience 
  • Understanding of multi-center drug and/or device trials.
  • Experience with Veeva TMF and CTMS systems.
  • Demonstrated expertise in applicable regulatory requirements and GCP.
  • Ability to establish and maintain effective professional relationships with co-workers, managers and clients.
  • Highly effective organizational and communication skills.
  • Ability to plan, identify risks, anticipate issues and outcomes and respond strategically, tactically and operationally while balancing short-term and long-term company objectives.
  • Demonstrated leadership skills and the ability to multitask and solve problems proactively.
  • Proficiency with Excel, PowerPoint and vendor management.
  • Multi-lingual communication 

9. BA in Biotechnology with 5 years of Experience

  • Pharmaceutical, Academic Research Organization or Clinical Research Organization research and project management experience
  • Technical/medical writing experience (protocol, IND, ICF, etc.)
  • Regulatory documentation, IND preparation and filing experience
  • Demonstrated project management skills, meeting project timelines and budgets.
  • Assisted in trial design, planning, and implementation - initiation through completion start
  • Solid understanding of the drug development process including GCP and FDA Code of Federal Regulations.
  • Excellent organizational, leadership, and problem-solving skills
  • Excellent written and verbal communication skills
  • Ability to successfully work both within a team and independently
  • Must have solid computer skills

10. BA in Microbiology with 10 years of Experience

  • Project management, product development and/or relevant experience
  • Experience in research and development
  • Working experience in clinical operations preferred
  • Previous experience with standard project management process (PMI)
  • Diagnostic, Medical Device, Pharmaceutical industry and/or relevant diagnostic area knowledge
  • Understanding of relevant Design Control and/or Phased Development processes
  • Successful problem-solving skills and ability to coordinate project activities
  • Excellent written and oral communication skills
  • Advanced stakeholder management, facilitation and negotiation skills
  • Proficient in MS Project and/or Project and Portfolio Management Tool
  • Ability to manage projects with ambitious milestones in high-pressure circumstances
  • Ability to manage projects with activity/milestone achievement to launch the product
  • Ability to escalate and drive management decisions about project execution and resource needs

11. BA in Molecular Biology with 9 years of Experience

  • Direct clinical research experience and must be in clinical research monitoring (on-site monitoring of nutritional, investigational drug or device trials) and a Senior CRA role, or equivalent.
  • Proven track record of successful management of all activities from pre-study activities to study completion for a multi-center domestic or international study or multiple smaller studies of less complexity (delivered on time, within budget, and with high quality).
  • Experience in managing studies involving countries with diverse regulatory requirements.
  • Demonstrated competence in the application of standard operating procedures, ICH GCPs, and local/global regulations.
  • Excellent team leadership skills. 
  • Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
  • Good written and verbal communication skills, acute observational skills, and analytical and conceptual capabilities.
  • Competence in the use of personal computers, including experience with word processing, spreadsheets, email and web-browser applications, electronic data capture systems, clinical trial management systems, and Sharepoint.

12. BA in Health Administration with 8 years of Experience

  • Experience in a clinical research environment, including experience working across multiple protocols
  • Fluent in English and French (and/or additional languages)
  • Experience with the development of key clinical trial documents (e.g., CRFs, ICFs, recruitment materials)
  • Tech-savvy with the skills and ability to apply new systems to her/his everyday tasks
  • Understand the importance of adaptability and eagerness to learn and adapt to technology changes over time
  • Ability to multitask proficiently across projects
  • Excellent oral and medical/technical writing skills
  • Ability to communicate effectively with sponsors/clients and team members
  • Strong interpersonal, leadership, and analytical skills
  • Ability to lead through influence without direct authority
  • Ability to demonstrate good judgment and decision-making, attention to detail, and personal accountability

13. BA in Life Sciences with 9 years of Experience

  • Prior experience in the pharmaceutical industry and/or related managed care or consulting environment
  • Adept in data analysis using statistical packages (e.g. SAS, R, Stata) and advanced analytical approaches
  • The ability to combine technical and business knowledge with analytical strength and creative problem-solving abilities.
  • Ability to independently execute HEOR projects including prospective and retrospective RWE, economic modeling, patient-centered outcomes research, posthoc analysis of clinical trials, and meta-analyses
  • Self-driven and highly motivated to tackle new challenges to demonstrate outcomes of innovative assets and ensure patient access through evidence-generation
  • Excellent oral and written communication skills
  • Demonstrate strategic mindset and ability to prioritize multiple projects according to dynamic business needs
  • Ability to work in a matrix organization with global cross-functional partners to align evidence-generation activities with global and affiliate priorities
  • Proficiency in Microsoft Word, Excel, and PowerPoint
  • Strong interpersonal skills, detailed-oriented and meticulous

14. BA in Health Informatics with 10 years of Experience

  • Direct project management work experience
  • Medical device (or related) trial work experience
  • Strong verbal communication and interpersonal skills with experience hosting large project meetings and driving engagement.
  • Effective written communication skills and ability to write professional/technical internal and external communications without oversight.
  • Experience in cardiovascular therapeutic areas for both pre-market and post-market clinical trials.
  • Applicable knowledge of clinical trial regulations for both the US and OUS.
  • Demonstrated leadership/management skills concerning the achievement of company goals and objectives.
  • Experience working in a broader enterprise/cross-division business unit model
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • The ability to leverage and/or engage others to accomplish projects.
  • Strong organizational and follow-up skills, as well as attention to detail.
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