Clinical Trial Project Manager

Daily Rate ~£400 / day

Greater London - Flexible working on offer

If you're an experience clinical trial manager with a passion for post authorisation and late phase studies, wanting to work with a market leading Global Pharmaceutical business than I would love to hear from you. 

3 exciting contract opportunities have arisen within a large pharma business where you are able to support and provide operational oversight to all areas of the Post Authorisation phase. 

You will serve as the main point of contact for CRO's, participating in CRO/Vendor selection and maintaining project goals are completed at each step. Working cross functionally will be a huge factor of this role and you will need to be able to communicate with a variety of audiences, making sure information is shared accurately. Maintaining all process and protocol documentation will be your responsibility, writing and reviewing the relevant documents (CRF's, Informed consent, Clinical Study Reports).

Working with other project teams you'll be responsible for all regional components of global post-authorisation studies and the entire process of EU post-authorisation studies. You will need to be comfortable to adapt to change and identify issues as quickly as possible. 

Must haves: 

• Previous experience in the management of Phase IV and Non-Interventional studies is essential.
• Knowledge of post-marketing requirements and different types of post-authorisation safety and efficacy studies.
• Clear and adaptable communication skills are essential to help share detailed information with multiple audiences.
• Strong knowledge and understanding of ICH GCP, GVP, FDA and EMEA regulations and guidelines applicable to post-authorization studies.
• you will have a BSc in a relevant scientific discipline and relevant clinical experience in the pharmaceutical or health care industry or equivalent.

If this role aligns with your current experience and is something of interest then I would love to hear from you. 

Please apply here or email me at Lorna@bluepelican.com

Sadly, without the relevant experience, you will not be considered for the vacancy so we ask that you're confident in your application suitability when applying.