Clinical Study Manager
An exciting opportunity has arisen for a Contract Clinical Study Manager in the UK to join a global biotechnology company. This is the perfect opportunity to help develop the face of medicine.
- Manage site budget and contract negotiation, payment, and processing activities in collaboration with the Study Manager, Legal, and Finance
- Participate in the selection of vendors, support Study Manager in oversight of vendors across assigned trials
- Collaborate with medical science liaisons (MSLs) and/or regional medical directors to support sites as appropriate
- Responsible for development of site enrolment plans, start up materials, informed consent document templates (ICD), and other trial related plans
- Participate in the preparation and finalization of protocols, clinical study reports, and interim reports
- Responsible for ensuring all supplies required for trial participation by sites are available
- Communicate with field CRAs and site staff for timely data collection and query resolution
- Oversee site documentation activities (TMF reconciliation, filing, and archiving)
- Responsible for implementation of corrective and preventative actions resulting from a site audit
- Identify potential protocol deviations and escalate per protocol deviation plan
People Management and Development
- Train, mentor and support junior staff supporting assigned trials, if assigned
Skills and Requirements
- Demonstrating willingness and flexibility to achieve a common goal when change occurs
- Taking ownership of, and accountability for, the completion of assigned tasks, while demonstrating professional maturity
- An ability to facilitate small (e.g., activity or country specific) meetings, including developing the agenda and completing follow-up, with oversight
- Being adept at recognizing a breach in GCP/GVP and ability to mitigate compliance risks for a clinical trial
- Understanding the objectives/purpose of each drug development phase
- Demonstrating basic knowledge of relevant therapeutic areas and disease conditions, particularly in rare diseases
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.