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Senior Clinical Team Manager – Neurology
Thermo Fisher ScientificClinical Team Manager overseeing clinical deliverables and quality in global clinical trials. Ensuring compliance with study protocols while managing clinical operations and team performance.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Accountable for achieving the final clinical deliverable (usually clean data from valuable patients as specified in the study protocol) within the time period specified in the contract with the customer
- Interprets data on project issues and makes good business decisions with support from expert team members or line manager
- Manages all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP
- Develops clinical tools (e.g. Supervising Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan
- Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents
- Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central)
- Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings
- Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained
- Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies
- Responsible for the timely archiving of documents and study materials for the department
Requirements
What you’ll need- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides knowledge, skills, and abilities to perform the job (comparable to 8+ years)
- PREFERRED therapeutic indication experience: Ophthalmology (General ophthalmology, Diabetic Macular Edema & Geographic Atrophy), Rare Disease (Myasthenia Gravis, Huntington's, ALS, DMD, CIDP, DM1 (myotonic dystrophy) and FSHD - CAR-T experience a plus), Sleep, Epilepsy, and/or Psychiatry
- PREFERRED experience level: 3+ years of CTM experience (North America) + global gCTM experience +/- biotech experience
- Knowledge, Skills and Abilities: Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams
- 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 sophisticated/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 digital literacy to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
Benefits
Comp & perks- Competitive remuneration
- Annual incentive plan bonus
- Healthcare
- Range of employee benefits
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical monitoringdata interpretationclinical operational managementquality assuranceclinical tools developmentTrial Master File managementbudgetingforecastingfiscal managementdata quality planning
Soft Skills
leadershipmentoringteam integrationplanningorganizational skillsinterpersonal skillsproblem-solvingjudgmentdecision-makingcommunication
Certifications
Bachelor's degreeICH GCP compliance