Clinical Trial Manager

Key Responsibilities

• Manages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Lead CTM responsibilities on a regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities.
• Develops clinical tools (e.g. Supervising Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Ensures timely setup, 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 as the need arises. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
• Collaborates with the clinical team and other departments as needed to meet the deliverables of the project. 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 standard 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.
• Ensures achievement of the final clinical deliverable within the contractual period specified by preparing and supervising clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing supervising visit reports, and managing CRF collection and query resolution. Continuously supervises clinical trials to assess performance and ensure contractual obligations are met. May routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
• Communicates with study sites regarding issues such as protocol, patient participation, case report form completion, and other study-related issues.
• May coordinate all start-up activities, and ensure that crucial document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions (if appropriate) are addressed. Reviews and follows up on all questions raised by ethics committees. Responsibilities may vary based on project timelines.
• Provides input into the preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities, and identification of additional resource requirements.
• Coordinates feasibility activities.

Education And Experience

Bachelor's degree or equivalent and relevant formal academic qualification.

Previous experience that provides the knowledge, skills, and abilities to perform the job.

Knowledge, Skills And Abilities

• Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams.
• Strong planning and organizational skills to enable effective prioritization of workload and workload of team members.
• Strong interpersonal and problem-solving skills to enable working in a multicultural matrix organization
• Solid understanding of change management principles.
• Comprehensive understanding of the practices, processes, and requirements of clinical monitoring
• Strong judgment, decision-making, escalation, and risk leadership skills.
• Effective oral and written communication skills, including English language proficiency.
• Capable of evaluating own and team members' workload against project budget and adjusting resources accordingly.
• Strong financial acumen and knowledge of budgeting, forecasting, and fiscal management.
• Strong attention to detail.
• In-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
• Strong digital literacy to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
• Capable of independently managing clinical studies.