Clinical Team Manager/Sr. (CTM) - Neuro

Join us as a Clinical Trial Manager and make an impact at the forefront of innovation. You will be accountable for achieving the final clinical deliverable—typically clean data from evaluable patients as specified in the study protocol—within the contractual timeframe. Your role ensures all clinical deliverables meet the customer’s expectations for time, quality, and cost while maintaining profitability through efficient management of the clinical team. This position involves working on projects of low to moderate complexity as part of a team of Clinical Trial Managers.

Responsibilities

• Manage all clinical operational and quality aspects of allocated studies (low to moderate complexity) in compliance with ICH GCP.
• Assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects, as required.
• Develop clinical tools (e.g., Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan.
• Contribute to the development of the Master Action Plan (MAP) for clinical-related documents.
• Ensure timely setup, organization, content, and quality of relevant sections of the Trial Master File (local and central).
• Participate in the design and development of CRFs, CRF guidelines, patient informed consent templates, and other protocol-specific documents.
• Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
• Work with the clinical team and other departments to meet project deliverables.
• Lead team meetings to ensure timelines, resources, interactions, and quality are maintained.
• Implement and train on standardized clinical monitoring processes within the study and according to corporate policies.
• Ensure timely archiving of documents and study materials for the department.
• Achieve the final clinical deliverable within the contractual timeframe by preparing and monitoring clinical activity timelines, providing status updates, reviewing projects using tracking tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution.
• Continuously monitor or co-monitor clinical trials to assess performance and ensure contractual obligations are met.
• In smaller regions, conduct Accompanied Field Visits (AFVs) and manage project financials.
• Communicate with study sites regarding protocol, patient participation, case report form completion, and other study-related issues.
• Coordinate start-up activities, including timely ethics committee and regulatory submissions (if applicable).
• Ensure essential document quality meets Regulatory Compliance Review expectations.
• Review and follow up on questions raised by ethics committees.
• Provide input into preparation of forecast estimates for clinical activities.
• Manage clinical resources, including assignment, delegation, and identification of additional resource requirements.

Requirements

• Bachelor’s degree or equivalent and relevant formal academic/vocational qualification.
• 5+ years of relevant experience in clinical research, including clinical trial operations, study management, clinical monitoring, or related activities.
• Transferable experience in healthcare, nursing, medicine, or related disciplines may be considered in combination with clinical trial experience where significant clinical expertise, therapeutic area knowledge, and direct patient care responsibilities are demonstrated.
• Experience in end-to-end study management of studies; Early Phase and Start-up experience preferred.
• Therapeutic experience preferred in:
  • Neurology (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)
  • Migraine

Skills

• Good leadership skills, effective at mentoring, training, and motivating teams.
• Strong planning and organizational skills to prioritize workload effectively.
• Solid interpersonal and problem-solving skills for working in a multicultural matrix organization.
• Ability to work effectively in a changing environment with complex or ambiguous situations.
• Familiarity with clinical monitoring practices, processes, and requirements.
• Good judgment and decision-making skills.
• Effective oral and written communication skills, including English language proficiency.
• Ability to evaluate workload against project budget and adjust 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).
• Proficiency in using automated systems and computerized applications (e.g., Outlook, Excel, Word).

Schedule

• Standard work schedule: Monday to Friday.

Environmental Conditions

• Work is performed in an office environment with exposure to electrical office equipment.
• Frequent driving to site locations and domestic/international travel required.