We are looking for an experienced Clinical Study Manager to join an established pharmaceutical company based in the South East, UK.
This is an exciting permanent opportunity for a Clinical Study Manager wishing to develop their expertise.
As Clinical Study Manager, your main responsibilities will include:
- Develop study plans and manage CRO performance and interface. These include the Quality Oversight Plan, Study Monitoring Plan, Clinical Management and Communications Plans and others as necessary.
- Ensure timely and cost-effective implementation of clinical trials.</li><li>Manage GCP compliance issues and assure appropriate communication, issue resolution and adherence to SOPs and guidelines.
- Liaise with colleagues in the other regions (US, Japan and Asia) for International Clinical studies.
- Assist in the preparation of drafts of entire Clinical Trial Protocols, Clinical Trial Reports and sections of Briefing Documents under the supervision of Clinical Study Leader.
- Appropriately contribute and input to the preparation of the Trial Master File, accordingly to company guidelines.
- Assess quality signals through on-site visits and propose revised monitoring strategies where necessary.
- Review and approve site contracts, informed consent forms, study budgets, work orders and invoices prior to final approval by Study Leader or Therapeutic Area Head.
- Participate in multi-disciplinary teams to deliver the Therapy Area strategy for Europe.
- Make presentations at management reviews, investigator and consultant meetings, as needed.
The ideal candidate for this Clinical Study Data Manager position will have the following skills, experience and expertise:
- Bachelor’s Degree in Life Sciences or higher.
- Extensive experience in clinical research in Europe
- Complete understanding of the concepts and applications of clinical research, medical terminology and other disciplines involved in drug development.
- Proficient skills in computer applications such as Word, Excel, and PowerPoint.
- Strong oral and written communication skills.
- Experience in managing third party vendors.
- Comprehensive knowledge of ICH GCP and associated guidelines.
- Ability to interpret data and to present results in a concise and clear manner.
- Management and leadership skills to direct reports and contractors to
- The successful completion of the project.
- Ability to work in a multicultural environment and to lead the interface
- Between development teams and CROs.
- Ability to work independently on technical problems of diverse scope applying novel and creative approaches to resolve complex operational issues and propose improvements to existing processes.
For more information or to apply for this Clinical Study Data Manager position, please contact Susan Murray at CK Clinical on 01438 743 047 or email firstname.lastname@example.org.