Clinical Team Manager / Sr. (CTM) - Neuro

Overview

Clinical Team Manager (Senior) to manage the clinical operations and quality of allocated low to moderate complexity studies, ensuring the final clinical deliverable is achieved within contractual time, quality and cost expectations.

What you'll do

• Manage all clinical operational and quality aspects of allocated studies of low to moderate complexity, in compliance with ICH GCP.
• May assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects in accordance with project-specific requirements.
• Develop clinical tools such as the Monitoring Plan and 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 set up, organization, content and quality of the relevant sections of the Trial Master File (local and central).
• May 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.
• Collaborate with the clinical team and other departments to meet project deliverables and lead team meetings to maintain timelines, resources, interactions and quality.
• Implement and train on standardized clinical monitoring processes within the study according to corporate standard policies.
• Ensure timely archiving of documents and study materials for the department.
• Prepare and monitor clinical activity timelines and metrics, provide status updates to the project manager, and implement recovery actions.
• Review monitoring visit reports and manage CRF collection and query resolution.
• Continuously monitor or co-monitor clinical trials to assess performance and ensure contractual obligations are met.
• In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
• May communicate with study sites regarding protocol, patient participation, case report form completion and other study-related issues.
• May coordinate start-up activities and ensure timely ethics committee and regulatory submissions, and follow up on all ethics committee questions.
• May provide input into forecast estimates for clinical activities.
• Manage clinical resources, including assignment, delegation of clinical responsibilities and identification of additional resource requirements.

What you'll need

• Bachelor's degree or equivalent, and relevant formal academic or vocational qualification.
• 5+ years of relevant experience in clinical research, including clinical trial operations, study management, clinical monitoring, or related clinical research activities.
• Transferable experience in healthcare, nursing, medicine or related disciplines may be considered in combination with clinical trial experience where the candidate demonstrates significant clinical expertise, therapeutic area knowledge and direct patient care responsibilities.
• Experience in end-to-end study management of studies.
• 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 complex or 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 such as ICH/GCP and FDA guidelines.
• Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel and Word.

Nice to have

• Early Phase and Start-up experience.
• Therapeutic experience in Neurology, including Ophthalmology (general ophthalmology, Diabetic Macular Edema and Geographic Atrophy), Rare Disease (Myasthenia Gravis, Huntington's, ALS, DMD, CIDP, DM1 and FSHD), Sleep, Epilepsy and/or Psychiatry (Depression and Schizophrenia), and Migraine.
• CAR-T experience.

Details

• Work schedule: standard, Monday to Friday.
• Work is performed in an office environment with exposure to electrical office equipment.
• Frequently drives to site locations and frequently travels both domestic and international.