CLINICAL TEAM MANAGER SKILLS, EXPERIENCE, AND JOB REQUIREMENTS

Updated: Nov 26, 2024 - The Clinical Team Manager brings extensive clinical research experience and a solid background in line management, including direct site management and monitoring. This role demands a deep understanding of FDA regulations and GCP/ICH guidelines, complemented by superior interpersonal and communication capabilities. With strong leadership and analytical skills, the manager excels in identifying issues, proposing innovative solutions, and mentoring teams, ensuring both regulatory compliance and operational efficiency.

Essential Hard and Soft Skills for a Standout Clinical Team Manager Resume
  • Clinical Trial Management
  • Regulatory Compliance
  • Data Analysis
  • Budget Management
  • Protocol Development
  • Medical Writing
  • Patient Recruitment Strategies
  • Pharmacovigilance
  • Electronic Data Capture Systems
  • Statistical Analysis Software Proficiency
  • Leadership
  • Communication
  • Problem-Solving
  • Adaptability
  • Team Collaboration
  • Decision-Making
  • Conflict Resolution
  • Attention To Detail
  • Time Management
  • Empathy

Summary of Clinical Team Manager Knowledge and Qualifications on Resume

1. BS in Pharmacy with 3 years of Experience

  • Qualified clinician in Allied Health, Nursing, Social Science, or other related fields
  • Demonstrated expertise in Home or Community Services setting
  • Previous management experience working in an operational fast-paced, service environment
  • Exceptional operational leadership experience
  • Demonstrated abilities in growing and developing people
  • Advanced understanding of service improvement, WHS principles 
  • Previous experience within a regulatory environment
  • Strong ability to manage resources and exceed targets
  • Proven record of accomplishment of successfully implementing change
  • Possess excellent skills in leading through relationships

2. BS in Nursing with 4 years of Experience

  • A licensed healthcare professional (ie, registered nurse) or equivalent work experience, required
  • Proven experience working in clinical research
  • Working experience in clinical trial management
  • Successful monitoring of working experience
  • Experience in managing complex or global trials
  • Working experience leading Oncology cellular therapy trials
  • Experience with oversight of clinical trials using genetically modified or somatic cell adoptive transfer in either autologous and/or allogeneic settings where cellular product logistics management was used.
  • Experience in managing all trial components (start-up to database lock)
  • Experience in coaching/mentoring other CTMs, leading a team of CTMs, participating in departmental initiatives
  • English fluency (the ability to read, write, and speak)

3. BS in Clinical Research with 5 years of Experience

  • Experience in clinical research, 
  • Full-service project management experience or an equivalent combination of education 
  • Experience sufficient to successfully perform the key responsibilities of the job.
  • Excellent leadership skills, promoting motivation and empowerment of others to accomplish individual, team and organizational objectives.
  • Demonstrates an excellent understanding of the clinical study, drug development, sample management and other associated processes and quality requirements.
  • Must have a strong project management mindset 
  • Demonstrate the ability to work and lead in a matrix team environment involving both internal and external partners.
  • Solid understanding of the country's local regulations, ICH-GCP guidelines and company written standards.
  • Flexible and resilient with the ability to evolve in a changing and challenging environment.
  • Demonstrates good English language written and verbal communication skills in addition to proven negotiation skills.

4. BS in Biomedical Science with 4 years of Experience

  • Working experience in a similar role at a CRO or pharma company
  • Experience working in Vaccine clinical trials
  • Strong interpersonal skills, organizational skills with the ability to lead
  • Ability to manage multiple priorities simultaneously
  • Able to work effectively within the local environment and collaborate extensively with geographically distant central team members. 
  • Ability to work effectively in a remote environment.
  • A quality-focused mindset
  • Demonstrated abilities in growing and developing people
  • Advanced understanding of service improvement, WHS principles 
  • Fluency in written and spoken English and Swedish

5. BS in Public Health with 6 years of Experience

  • Equivalent combination of studies, nursing qualifications and/or work experience
  • Relevant clinical research experience, including a CTM or equivalent role
  • Experience in aspects of clinical study management, including the review of visit reports and the development of study-related documents
  • In-depth working knowledge of current ICH-GCP guidelines and applicable regulations
  • Thorough knowledge of the clinical research process
  • Strong communication skills including effective verbal, written and presentation skills (English and/or local language)
  • Demonstrated ability to lead, mentor and provide clinical guidance to team members
  • Intermediate proficiency in Microsoft Word, Excel, Outlook, Internet Explorer and PowerPoint
  • Must have a strong project management mindset 
  • Self-motivated, detail-oriented, and flexible with the ability to prioritize workload effectively.

6. BS in Healthcare Administration with 7 years of Experience

  • Clinical research working experience.
  • Working experience in line management
  • Direct site management experience (monitoring) experience
  • Comprehensive knowledge of FDA regulations and GCP/ICH guidelines.
  • Exceptional interpersonal and communication skills, both written and verbal.
  • Self-motivated, detail-oriented, and flexible with the ability to prioritize workload effectively.
  • Well-developed planning, observation, analytical and problem-solving skills are essential.
  • Must demonstrate independent judgment and decision-making skills concerning functional responsibilities including innovation, originality and creativity
  • The ability to proactively identify issues and risks, analyze root causes, and propose solutions to problems and escalate to management
  • Strong leadership and negotiation skills as well as excellent influencing and training/ mentoring skills
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