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Clinical Team Manager – Neuro
Thermo Fisher ScientificClinical Team Manager overseeing clinical operational and quality aspects of studies for Thermo Fisher Scientific. Ensuring compliance with ICH GCP and achieving project deliverables.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical operations and quality for studies, ensuring compliance with ICH GCP, while effectively coordinating timelines and resources. Proficient in developing clinical tools and facilitating communication with stakeholders to achieve clinical deliverables.
Highest-signal resume keywords
Clinical Operations ManagementEnd-To-End Study ManagementICH GCP ComplianceTherapeutic Experience (Neurology, Ophthalmology)Team Leadership and Communication
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Tool DevelopmentMonitoring Plan CreationClinical Activity Timeline ManagementRegulatory Submission CoordinationData Quality Plan Development
Soft Skills
Effective CommunicationTeam CollaborationMeeting Facilitation
Certifications & Qualifications
Bachelor's Degree or Equivalent
Industry Keywords
Early Phase StudiesStart-Up ExperiencePatient ParticipationCase Report Form CompletionEthics Committee Submissions
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- 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.
- Ensure achievement of the final clinical deliverable within the contractual time period by preparing and monitoring clinical activity timelines and metrics.
- Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained.
- Ensure timely archiving of documents and study materials for the department.
- May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
- Coordinate all start-up activities and ensure that timely ethics committee and regulatory submissions are addressed.
Requirements
What you’ll need- 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).
- Looking for CTMs with experience in end-to-end study management of studies.
- Early Phase and Start-up experience preferred.
- Therapeutic experience (Neurology) preferred: 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 (Depression & Schizophrenia)
Benefits
Comp & perks- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options