Senior Clinical Team Manager - Neuroscience

About the role

Thermo Fisher Scientific is looking for an experienced Clinical Team Manager (CTM) to join its Neuroscience team. The Senior CTM is accountable for delivering the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the contractual time period, while keeping clinical activity within the contract scope to maintain profitability. The role covers projects of low to moderate complexity and works as part of a team of CTMs.

Key responsibilities

• Manage all clinical operational and quality aspects of allocated studies in compliance with ICH GCP, and may take on Clinical Study Manager responsibilities on smaller or less complex projects.
• Develop clinical tools such as Monitoring Plans and Monitoring Guidelines together with the Data Quality Plan, and contribute to the Master Action Plan for clinical documents.
• Ensure the Trial Master File (local and central) is set up, organized and kept up to date; may help design CRFs, CRF guidelines and patient informed consent templates.
• Collaborate with the project manager on client meetings, including bid defense and hand-off meetings, and lead team meetings to keep timelines, resources, interactions and quality on track.
• Implement and train standardized clinical monitoring processes, and archive documents and study materials.
• Monitor clinical trials continuously, review monitoring visit reports, manage CRF collection and query resolution, and implement recovery actions.
• In smaller regions, may conduct Accompanied Field Visits (AFVs), be accountable for project financials, and coordinate start-up activities including ethics committee and regulatory submissions.
• Manage clinical resources, delegate responsibilities and identify additional resource needs.

Required profile

• Bachelor's degree or equivalent, and relevant formal academic or vocational qualification.
• Previous experience comparable to 8+ years; equivalency through education, training and/or related experience may be considered.
• Extensive experience in ophthalmology (general, diabetic macular edema, geographic atrophy), rare diseases (myasthenia gravis, Huntington's, ALS, DMD, CIDP, DM1, FSHD - CAR-T experience a plus), and sleep, epilepsy and/or psychiatry (depression and schizophrenia).

Required skills

• Familiarity with clinical monitoring practices, processes and requirements.
• Good leadership, mentoring and communication skills, including English proficiency.
• Knowledge of ICH/GCP and FDA guidelines, and sound financial acumen with budgeting and forecasting.
• Computer skills with Outlook, Excel and Word.