Clinical Team Manager – Senior
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Job Description
Senior Clinical Team Manager managing clinical operational and quality aspects of studies. Working at Thermo Fisher Scientific to ensure clinical deliverables meet quality and timelines.
Responsibilities:
- Manage all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP.
- Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan.
- Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
- Collaborate with the clinical team and other departments as needed to meet deliverables of the project.
- Responsible for the implementation and training of standardized clinical monitoring processes within the study.
- Ensure achievement of the final clinical deliverable within the contractual time period specified.
- Communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
- May coordinate all start-up activities, and ensure that essential document quality meets the expectation of Regulatory Compliance Review.
Requirements:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
- Preferred experience: experience in STM role and/or previous experience in non-interventional / Phase IV studies / RWE studies.
- Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams.
- Strong planning and organizational skills to enable effective prioritization of workload and workload of team members.
- Strong interpersonal and problem solving skills to enable working in a multicultural matrix organization.
- Solid understanding of change management principles.
- Comprehensive understanding of the practices, processes, and requirements of clinical monitoring.
- Strong judgment, decision making, escalation, and risk management skills.
- Effective oral and written communication skills, including English language proficiency.
- Capable of evaluating own and team members workload against project budget and adjust resources accordingly.
- Strong financial acumen and knowledge of budgeting, forecasting and fiscal management.
- Strong attention to detail.
- In-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
- Strong computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
- Capable of independently managing clinical only studies.
Benefits:
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
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