(Senior/Principal) Clinical Team Manager - General Medicine

at  Thermo Fisher Scientific

(SENIOR/PRINCIPAL) CLINICAL TEAM MANAGER - GENERAL MEDICINE

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD Clinical Research Services — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.
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.
Currently, we are looking for an experienced Clinical Team Manager to join our team. This exciting and unique role could take you the next step of your career within Clinical Research. As a Senior 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. We require experienced CTM’s with Cell & Gene Therapy experience ideally in CAR-T Autoimmune.

The role coordinates all aspects of clinical activities on an international basis, including:

• Day to day management and leadership of a team of Clinical Operations members who are allocated to a project on a Country basis
• Responsibility for the achievement of the project clinical deliverables within the contractual timelines and budget
• Development of clinical tools (e.g. Monitoring Plan and Guidelines) and set up of the required training, tracking and quality systems
• Work in partnership with the Project Manager to prepare, organize, and present at client meetings, including bid defense and kick off meetings
• Clinical Resource Management – provide input into preparation of forecast estimates of clinical deliverables, assignments and identification of additional resource requirements
• Acting as a contact and support to the Sponsor for all clinical-related aspects of the project

KNOWLEDGE, SKILLS AND ABILITIES:

• Superior organizational skills
• Critical thinking skills
• Demonstrated performance management abilities
• Excellent judgment and decision-making skills
• Highly effective verbal and written communication and presentation skills
• Experienced knowledge of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.

• Day to day management and leadership of a team of Clinical Operations members who are allocated to a project on a Country basis
• Responsibility for the achievement of the project clinical deliverables within the contractual timelines and budget
• Development of clinical tools (e.g. Monitoring Plan and Guidelines) and set up of the required training, tracking and quality systems
• Work in partnership with the Project Manager to prepare, organize, and present at client meetings, including bid defense and kick off meetings
• Clinical Resource Management – provide input into preparation of forecast estimates of clinical deliverables, assignments and identification of additional resource requirements
• Acting as a contact and support to the Sponsor for all clinical-related aspects of the projec