(Sr) CTM - Non-Interventional Studies

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.

We are seeking a (Sr) Clinical Team Manager for our Non-Interventional Studies Team in the EMEA region.

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.

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
  
  

• Bachelor's degree or licensed certified health care training or equivalent combination of education and experience
• 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. The team would also consider strong experience in oncology and gene therapy.
• Other preferred experience is PCRA or Lead CRA level experience handling CTM tasks, 3+ years of onsite monitoring, and experience working with partnerships (pharma/biotech companies).
• Clinical research experience in all phases of study life cycle, including start up, interim and close out
• Study finance management experience
• Ability and willingness to cross-region and in region travel according to the project needs
• Valid Passport and Driving License
• Be proficient in use of written and oral English language
  
  

• Outstanding organizational skills
• Critical thinking skills
• Proven 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.
• Capable of independently leading clinical only studies