Freelance Associate Director of Clinical Operations
An amazing job opportunity has become available for a Freelance Associate Director of Clinical Operations to join a biotechnology organisation. This Belgium based organisation is renowned for its work on high-quality medicine to help people live longer, healthier and more active lives. This is an exciting opportunity to bring expertise and skills to an established and in-demand company.
- Is responsible for the overall coordination of the clinical team and monitoring of daily
activities to ensure the successful completion of clinical trials.
- S/he participates in the planning, implementation, monitoring and management of clinical trials in compliancewith applicable regulations.
- Interacts with applicable vendors to ensure that contractual obligations related to clinical
activities are met.
- Provide support to, the CSM and CRA to ensure the timely initiation and completion of clinical trials.
- Conducts daily, ongoing communication responding to inquiries from clinical team members and clinical sites; as applicable.
- Ensures clinical study team resources are continuously adequate; participates in the interview and selection of clinical personnel for studies.
- Participates in the coordination and conduct of study specific training, as appropriate; ensures standards for monitoring and reporting are met.
- Participates in the analysis and development of the Clinical Operations department budget.
- Participates in audits as required; oversees follow-up activities and ensures timely implementation andcompletion of corrective action plans in close cooperation with QA, as appropriate.
- Performs other duties as assigned by upper management;
Skills and Requirements
- Bachelor's degree in a life science or related field of study or equivalent combination of studies
- 10+ year's relevant experience in clinical operations.
- Considerable depth of experience in clinical study management, monitoring, and in developing study-related documents.
- In-depth knowledge of ICH-GCP guidelines and applicable regulations.
- Intermediate proficiency in Microsoft Word, Excel, Outlook, Internet Explorer, Power Point and MS Project
- Effective verbal and writing skills
- Fluent in English
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 Lewis Davis at +44 203 078-9569 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.