Senior Clinical Team Manager - HemOnc

Senior Clinical Team Manager position

Become a valued member of the distinguished team at Thermo Fisher Scientific Inc.! We are in search of a Senior Clinical Team Manager with proven Global CTM experience to elevate our research pursuits to greater heights. This role provides a chance to engage in innovative projects that will profoundly shape global healthcare.

Our Project Delivery team directs, coordinates and leads the technical and operational aspects of projects, securing the successful completion of clinical trials. The team is therapeutically aligned to respond better to our customer needs. The therapeutic scope includes the following therapeutic areas/indications: Ovarian, Sickle Cell, Non-Hodgkins Lymphoma, Multiple Myeloma, Glioma, Head and Neck, Pancreas, Prostate, Non-Small Cell Lung, Breast, Colorectal, Radiopharmaceutical, Cell and Gene Therapy, and/or CART-T.

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. 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.

Summarized Purpose

Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) 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. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically works independently on projects of moderate to high complexity and may assume regional lead or Clinical Study Manager responsibilities.

Essential Functions

Leads 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 regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; e.g. process improvements, lead complex programs, have wider management or project coordination responsibilities.

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). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.