(Sr) CTM - Non-Interventional Studies

Work Schedule

Environmental Conditions

Job Description

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

Does this sound like you? If so, you need to have:

• 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

Knowledge, Skills and Abilities:

• 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
  

If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!