We are looking for executives to work on clinical trial & regulatory affairs projects across their lifecycle, across recent project acquisition, strategy & planning, medical writing, regulatory affairs & clinical operations. The role suits professionals who enjoy working across functions and taking ownership in a lean, fast-paced team.
1. Coordinating clinical trial & regulatory affairs projects execution from site selection and study initiation through monitoring and close-out, across multiple sites and projects.
2. Managing relationships with investigators, site staff, ethics committees, vendors & partners.
3. Preparing and coordinating EC/IRB and regulatory submissions, and managing the interface with regulatory authorities.
4. Contributing to development and review of protocols, eCRF, study documents & reports.
5. Contributing to the evolution of SOPs, document templates & quality systems based on regulatory updates and evolving industry practices.
6. Maintaining TMF & other project documents
7. Supporting new project strategy & planning,
including operational plans and budgets.
8. Planning & tracking project timelines, key milestones & deliverables.
9. Managing client interface, including regular progress reports and alignment with their requirements & expectations.
Preferred candidate profile
1. 3-6 years of experience in clinical research, in clinical operations, regulatory affairs and/or project coordination, preferably in global clinical trials. Hands-on experience across more than one area will be preferred.
2. In-depth understanding of GCP, clinical trial regulations, industry standards and contemporary practices.
3. A degree in pharmacy, medicine or life sciences.
4. Proficiency in MS Office, particularly MS Word & MS Excel.
5. Excellent verbal and written communication skills.
6. Willingness to work across functions and adapt to evolving project needs.
7. Ability to organize and prioritize workload & take initiative.