CTM/Sr CTM - EMEA - FSP
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Our global Clinical Operations colleagues within our clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.
The FSP Solution:
PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success. Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.
Discover Impactful Work:
To lead local study teams at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with international guidelines such as ICH-GCP as well as relevant local regulations. In addition may perform site monitoring as needed to support the flexible capacity model. The position is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.
A Day in the Life:
- Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
- Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies
- Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations.
- Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
- Coordinates the site selection process by identifyin