Pharmaceutical Development Coordinator - Project Manager

Pharmaceutical Development Coordinator - Project Management

This is a chance to join a global business who operate across multiple sectors. This role will be North West, UK based and will be providing oversight to 3rd party CRO''s and support to a Project Manager at a sister organisation.

The Role:

As the Pharmaceutical Development Coordinator, your main responsibilities consist of the following:

Oversight of projects and activities related to pharmaceutical developments in the area of rare metabolic diseases.
Liaise with the Project Manager to track all clinical developments that require oversight by the business and appropriate reporting of pre-clinical/clinical safety findings and SAEs.
Reporting developments to the Leadership Team in relation to Pre-clinical, CMC, Clinical Operations and Regulatory Affairs.
Tracking and reviewing all documentation necessary to meet responsibility for oversight of clinical trial conduct as sponsors and appropriate maintenance of IND and other applications, including maintenance of appropriate SOPs that ensure the conduct of all mandatory activities related to clinical trial/IND sponsorship, training of appropriate personnel on those SOPs.
Liaising with the Project Manager, Regulatory Affairs Manager and US Agent to track and ensure oversight over all IND amendments, reports and communications to FDA and other regulatory authorities as required.
Preparation of a monthly Oversight Committee meeting with the Leadership team.
Training of relevant personnel involved in Clinical Development, Clinical Operations and any third party CRO to which clinical responsibilities are delegated.

Ideal Candidate:

Educated to degree level or equivalent in Life Sciences
Experience within the pharmaceutical industry and a working knowledge of the conduct of clinical trials to GCP is essential
Working knowledge of the drug development process and the Regulatory environment
Experience of working within multi-disciplinary teams, preferably in a team leader or project management role
Excellent communication that reflects the ability to build relationships with all stakeholders

For more info get in touch with Dan at Core Talent