Are you an experienced Clinical Operations Leader looking for an exciting job opportunity?
We are currently looking for a Clinical Operations Leader to join a leading biopharmaceutical company based in the Cambridgeshire area on a 12 month fixed term contract to cover maternity leave.
As the Clinical Operations Leader you will lead the set-up, management and reporting of the company's sponsored clinical trials in accordance with ICH GCP and applicable regulatory guidelines.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Clinical Operations Leader will be varied however the key duties and responsibilities are as follows:
1. You will be responsible for leading the day to day management of the clinical trial programme as well as management of junior members of the department.
2. You will lead the clinical programme budget discussions and forecasting activities as well as lead the clinical trial outsourcing activities and selection of vendors.
3. As well as contribute to the content and writing of trial documentation, you will also support the regulatory activities in the department such as CTA application and scientific advice procedures.
4. As the Clinical Operations Leader, you will also act as a senior point of contact for clinical trial vendors including clinical research organisations, consultants and clinical sites.
To be successful in your application to this exciting opportunity as the Clinical Operations Leader we are looking to identify the following on your profile and past history:
1. Relevant degree in a Biomedical discipline and knowledge of the ICH GCP and regulatory guidelines relevant to sponsor oversight of clinical trials is essential for this role.
2. Proven industry experience working in a commercial pharmaceutical setting and experience in clinical trial management and delivery are also essential.
3. Additionally, you must have experience in early phase clinical studies. Any experience in diabetes studies is high advantageous.
Key Words: Clinical Trials | Clinical Operations Leader | ICH GCP | Regulatory | Pharmaceutical | Life Science | Biopharmaceutical
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.