We are currently looking for a Clinical & Quality Project Manager to join a leading Biopharmaceutical company working remotely. As the Clinical & Quality Project Manager, you will be responsible for managing the delivery of revisions to clinical research policies, SOPs, templates and forms (the clinical Quality Management System).
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Clinical & Quality Project Manager will be varied however the key duties and responsibilities are as follows:
1. You will be managing and tracking the work of external QA vendor(s) in the development of clinical research-related SOPs, to agreed time-lines and budget.
2. As the Clinical & Quality Project Manager you will be Co-ordinating and tracking the work of internal subject matter experts in the development of clinical research-related policies.
3. You will be reviewing SOPs developed by external QA vendor(s) and internal staff in compliance with ICH GCP, regional regulations, practicability and consistency.
4. As the Clinical & Quality Project Manager you will be identifying opportunities to maximize efficiencies and cost-savings within the outsourced QMS project work.
To be successful in your application to this exciting opportunity as the Clinical & Quality Project Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in Science or equivalent.
2. Proven industry experience working as a Clinical Project Manager.
3. A working knowledge and practical experience with GCP Quality Management Systems.