Ref #: 39550

Employment type: Permanent - Full-Time

Location: France

Posted: 11-Oct-2022

Description

• Builds and manages site relationships
• Oversees site-level study start-up, conduct, and close-out activities outsourced to a CRO for global programs across different Therapeutic Areas, including without being limited to
o Supports Site Agreement negotiations, including stand-alone and Master Site Agreements
o Identifies trends, issues and risks across sites, and works with external vendors as well as the with the Clinical Trial Team to resolve/mitigate those
o Ensures, in collaboration with external vendors as well as internal Clinical Trial Team that the sites under his/her area of responsibility are activated in a timely manner and according to
company’s agreed timelines
o Ensures, in collaboration with external vendors as well as internal Clinical Trial Team that the sites under his/her area of responsibility deliver on expected recruitment targets, including
identifying reasons for non-recruitment, and identification of non-performing sites that require actions
• Develops and implements a plan in collaboration with the global and local organization to raise the profile of the company and its global clinical development projects with current and potential
investigators
• Independently perform activities associated with the evaluation of investigational sites to build company network
• Ensures ICH/GCP/local regulatory requirements are observed
• Proactively works with Medical/Patient/Industry Associations to build company network and to promote company clinical trials

Bachelor's Degree in Medical or Life Science required

1. Ability to work independently on assigned tasks or projects of increasing complexity
2. Expert knowledge of clinical operations (principles and concepts as well as regulatory environment)
3. Aptitude to interpret and to integrate site performance data in prioritization of oversight activities
4. Solid clinical knowledge and experience in clinical development/ operations with the capacity to oversee site conduct including pharmacy, labs and other support departments for clinical trials
5. Experience in clinical development/operations (minimum of 8 years)
6. Capability to perform self-training incl. on therapeutic area, and synthesize the key take-away points for studies under remit
7. Strong communication skills -verbal, written and listening, both in native language and English
8. Record of having worked in multiple therapeutic areas relevant to company portfolio
9. Normally receives no instruction on routine work and only general instruction on new assignments
10. Sound negotiation skills and adapting to a variety of parties
11. Record of vendor interactions
12. Detailed understanding of all aspects of clinical protocol design and implementation, clinical site monitoring as well as overall global drug development required
13. Proven understanding of FDA, EMA, ICH and GCP guidelines and applicable local regulations
14. Sound critical thinking skills and ability to understand complex patient histories, medical terminology and specific therapeutic area treatment landscapes
15. Detail-oriented, organized and committed to quality and consistency
16. Results driven and capable of managing competing high-priority assignments
17. Proven track record of achieving deliverables within specified timelines
18. Ability to work in a dynamic environment with a high degree of flexibility
19. Ability to communicate effectively with Key Opinion Leaders, site staff, and internal team members
20. Experience and proven proficiency in CTMS and eTMF systems preferred

Icon DOCS offers competitive salary and benefits!