Sr. Clinical Team Manager (CTM) - Non Interventional Studies (NIS)

Thermo Fisher Scientific

279d • Remote

About The Position

PPD's (a part of Thermo Fisher Scientific) mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it's you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our dedicated, forward-thinking and energetic teams. Our non-interventional Peri and Post Approval Research Operations group consists of colleagues with institutional knowledge, broad and in-depth therapeutic experience, and robust operational tools to help our clients deliver life-changing therapies to market. You take ownership, anticipate problems, find solutions and deliver results. Together, we help clients define and develop clinical programs, minimize delays and implement high-quality, cost-efficient clinical studies. As a Clinical Team Manager (CTM), you combine deep knowledge, therapeutic expertise, and robust tools to help our clients deliver life-changing therapies to market. You take ownership, anticipate problems, find solutions and deliver results; coordinating the activities of Clinical Management members which are allocated to a project on a Regional or Country basis. You will work in partnership with the Project Manager to ensure the necessary training, tracking and quality systems are in place for the clinical management team and be primarily responsible for the clinical deliverables of the Project within agreed timelines and budget. Clinical Team Managers provide contact and support to the project sponsor for all clinical aspects.

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).
• Global study experience is highly preferred.
• Non Interventional studies and/or Real World Evidence experience is also preferred.
• Strong experience in oncology and gene therapy is a plus.

Nice To Haves

• 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, critical issue, and risk management skills.
• Effective oral and written communication skills, including English language proficiency.
• Strong financial skill 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.

Responsibilities

• Leads all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP.
• Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan.
• Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents.
• Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central).
• Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
• 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 standardized clinical monitoring processes within the study and according to corporate standard policies.
• Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics.
• Continuously monitors clinical trials to assess performance and ensure contractual obligations are met.
• Communicates with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
• Provides input into preparation of forecast estimates for clinical activities.
• Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree