Proclinical is seeking a Project Management Associate P2 to join a dynamic team in Wrexham, UK. This role offers a hybrid working model, with 2-3 days per week in the office and the remainder from home. You will play a key role in supporting clinical trials, scientific documentation, and compliance activities in a fast-paced environment. Strong technical writing skills and digital literacy are essential for success in this position.
Responsibilities:
1. Provide trial support by maintaining organization, records, and reports.
2. Ensure compliance with regulatory requirements and company policies, with a focus on accurate documentation.
3. Coordinate communications with external clients and partners.
4. Manage travel arrangements and schedule meetings.
5. Assist senior managers with clerical and administrative tasks.
6. Draft, review, and coordinate study documents, protocols, and reports.
7. Support the submission of scientific publications, including posters and peer-reviewed articles.
8. Facilitate engagement with regulatory agencies (e.g., EMA, FDA) regarding novel eCOA and digital biomarkers.
9. Create presentations, figures, and visuals for internal and external use.
10. Conduct literature searches on therapeutic areas, digital health technologies, and regulatory updates, sharing insights with the team.
11. Stay informed on regulatory guidance related to electronic data collection, digital biomarkers, and decentralized clinical trials.
Key Skills and Requirements:
12. Background in life sciences with experience in research or project management.
13. Interest in digital health technologies, drug development, and regulatory affairs.
14. Proactive problem-solving skills with a vision for process improvement.
15. Strong digital proficiency and technical writing abilities.
16. Excellent organizational, time-management, and communication skills.
17. Effective presentation and public-speaking capabilities.
18. Ability to collaborate effectively within a team.
19. Relevant experience in a similar role is highly desirable.