Contract Clinical Study Manager
A UK-based biotechnology company is seeking to recruit a Regulatory RIM Consultant. This position will provide Global Regulatory Affairs Operations support for Regulatory Information Management (RIM) system and associated activities.
- Participating in design and authoring clinical study protocols and investigator brochures.
- Leading the selection of and managing CROs.
- Responsible for CRO oversight from trial set up through to close out, including investigator/site identification, ongoing trial management, monitoring, and data collection activities across all regions.
- Ensuring efficient running of clinical trials to time and budget.
- Coordinating clinical study reports.
- Providing senior management with timely updates on the progress, changes in scope and resource requirements for all clinical studies.
- Travelling to national and international sites as required for sponsor-led audits, investigator meetings and relevant conferences.
Skills and Requirements:
- Degree in a relevant discipline
- 5+ years' experience within the pharmaceutical industry in clinical operations, including project management experience, ideally at national and international level
- Strong experience of vendor management and oversight of clinical studies and study teams across all phases of development including, global phase III
- Familiarity with a broad spectrum of clinical operations concepts, practices, and procedures with an understanding of the process and regulations that apply to clinical investigations including knowledge of EMA/FDA regulatory requirements and ICH GCP guidelines
- Strong scientific, operational and regulatory expertise. Demonstrates knowledge of design and operational management of clinical studies globally, including regulatory requirements, CRO capabilities and compliance practices
- Contributes towards development and implementation of process to ensure clinical studies are managed within a robust regulatory and operational framework.
- Collaborates with other key functions to maintain audit and inspection readiness.
- An understanding of the interplay between functional areas in early development.
- Ideally some expertise in the field of rare diseases and of performing phase 1 studies in patients.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 +44 207 440 0639 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
£0.00 - £350 per hour
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