Clinical Team Manager / Sr. Clinical Team Manager (CTM) - NIS

About the role

The Senior Clinical Team (Trial) Manager is accountable for achieving the final clinical deliverable within the time period specified in the contract with the customer. Interprets data on complex issues and makes good business decisions with support from line management. The role involves working to ensure that all clinical deliverables meet the customer's time/quality/cost expectations, and maintaining profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team.

Responsibilities

• Manage all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP.
• 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 providing clinical related documents.
• Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central).
• 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 as needed to meet deliverables of the project.
• Regularly communicate with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained.
• Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies.
• Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution.
• Continuously monitor clinical trials to assess performance and ensure contractual obligations are met.
• Communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.

Requirements

• 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 8+ years).
• Preferred experience: experience in STM role and/or previous experience in non-interventional / Phase IV studies / RWE studies.

Skills

• 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 management skills
• Effective oral and written communication skills, including English language proficiency
• Capable of evaluating own and team members workload against project budget and adjust 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 computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.

Working Conditions and Environment

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.