Overview
Real World Evidence Coordinator – Location: Maidenhead (hybrid working available). Duration: 6 months initial (Temporary). Rate: up to £18 per hour (PAYE or Umbrella).
Responsibilities
- Serve as a subject matter expert for investigator-initiated study setup processes.
- Provide input into feasibility and management of clinical research involving Investigational Medicinal Products.
- Collaborate with global and local teams to monitor study progress and ensure timely drug supply delivery.
- Manage eTMF record keeping and maintain Trial Master File for essential study documents.
- Track milestones and maintain accurate records of investigational drug shipments.
- Ensure compliance with country regulations, GCP, ICH Guidelines, and company SOPs.
- Support audit and inspection readiness and participate in pre-audit activities.
- Manage budgets, invoices, and financial records for affiliate research studies.
- Prepare and execute study contracts and statements of work.
- Utilize feedback to improve processes, systems, and solutions.
Skills/Experience Required
- Life Sciences Degree (e.g. Pharmacy) or equivalent experience.
- Experience in a similar role within pharmaceutical or clinical research.
- Knowledge of ICH/GCP Guidelines and applicable local regulations.
- Extensive experience in Trial Master File record keeping and investigational drug shipment coordination.
- Experience in managing contracts and finance is desirable.
- Strong planning and organisational skills with ability to manage multiple projects.
- Proactive and positive team player with strong attention to detail.
- Fluency in English and local language (if not English).
- Proficiency in standard IT office tools and advanced Excel skills.
- Experience in audits and inspections.
To Apply
If you are interested and want