Clinical Study Management Associate
Proclinical is excited to announce a contract home-based role for Clinical Study Management Associate within the UK. This biotechnology company would like a talented individual to ensure clinical trials are conducted in accordance to ICH/GCP and delivered on time and on budget.
- Performs oversight activities of the CRO per the Vendor Oversight Plan.
- Conducts co-monitoring in designated region.
- Responsible for the review of clinical trial documents including consent documents, confidentiality agreements, study related plans and Investigator agreements (CTA)s.
- Responsible for oversight of IRB/EC and RA submissions within designated region.
- Take Vendor Lead responsibilities according to business and trial requirements.
- Reviews and approves essential document packages to enable timely site activations.
- Reviews pre-study, study initiation, interim monitoring visit and study closeout visit reports and ensures findings are addressed with the CRO and looped back to the wider study team as required.
- Partners with the CRO to ensure robust ongoing quality monitoring strategies are carried out effectively to deliver high-quality data.
- Oversees investigator performance and adherence to protocol, and proactively addresses conduct issues and enrolment problems, as necessary.
- Responsible for oversight and maintenance of the TMF and completeness at the end of the study.
- Ensures study inspection readiness.
Skills and Requirements
- Typically requires a BSc or BA in a relevant scientific discipline or RN qualification
- Vendor (CRO) oversight experience preferred
- CRA experience preferred
- Acute Indication/Infectious Disease experience preferred
- A good understanding of the drug development process, ICH/GCP guidelines and specifically, each step within the clinical trial process.
- Experience with clinical studies in infectious diseases would be a plus
- Demonstrated ability to work in a fast-paced team environment with high productivity.
- Enjoys building strong working relationships with colleagues and CRO personnel.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Matthew Pike at 0207 440 0639 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.