Senior Clinical Team Manager – Clinical Lead, Non Interventional, Observational Studies
Thermo Fisher Scientific
full-time
Posted on:
Location Type: Remote
Location: Poland
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Job Level
Tech Stack
About the role
- Manage all clinical operational and quality aspects of allocated studies, of low to moderate 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.
- Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained.
- Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager.
- May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
- May provide input into preparation of forecast estimates for clinical activities.
- Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.
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 5+ years and a minimum of 2 years experience as a CTM).
- Experience in Non Interventional/Observational studies is required
- Experience in managing Global studies is preferable
- Experience in managing start up activities
- Good planning and organizational skills to enable effective prioritization of workload
- Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization
- Capable of working effectively in a changing environment with complex/ambiguous situations
- Familiarity with the practices, processes, and requirements of clinical monitoring
- Good judgment and decision making skills
- Effective oral and written communication skills, including English language proficiency
- Capable of evaluating workload against project budget and adjusting resources accordingly
- Sound financial acumen and knowledge of budgeting, forecasting and fiscal management
- Strong attention to detail
- Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
- Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
Benefits
- Competitive salary
- Flexible working hours
- Professional development budget
- Home office setup allowance
- Global team events
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical operational managementquality managementclinical monitoringresource managementbudgetingforecastingdata quality planningclinical deliverable managementstart-up activities managementnon-interventional studies
Soft Skills
planning skillsorganizational skillsinterpersonal skillsproblem solving skillsjudgment skillsdecision making skillscommunication skillsattention to detailadaptabilityprioritization skills
Certifications
Bachelor's degreeICH GCP certification