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Senior Clinical Trial Management Associate

Employer
Planet Pharma Staffing Limited
Location
Uxbridge, London (Greater) (GB)
Salary
Day Rate
Start date
8 Aug 2022
Closing date
7 Sep 2022

Job Details

Senior Clinical Trial Management Associate

The Clinical Operations team is responsible for the execution of all Phase 1-4 clinical trials, across all therapeutic areas, around the world.

In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Clinical Operations ensures that all clinical trial activities are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialisation of clients products. There are now looking for an experienced Senior Clinical Trial Management Associate to join the team based in Uxbridge.

Essential Duties and Job Functions:
• Assist global trial managers with set-up of central labs and study vendors as required, including liaising with study management CRO to ensure site training and timely initiation.
• Performs accompanied visits (PSSVs, SIVs, RMVs) with CRO CRAs to ensure correct study procedures according to Gilead SOPs and protocol procedures, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
• Under supervision may assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports. May assist in compilation of investigator brochures under close supervision.
• Review of trip reports generated by CRO CRAs.
• Communicates and collaborates with other functional groups including but not limited to Clinical Research, Regulatory Affairs, CCF, Materials and Logistics (M&L), and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities.
• Assists in the Management of the CROs and vendor’s as required.
• Assists with the preparation and organization of international investigator meetings.
• Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.
• Performs administrative duties in a timely manner as assigned.
• Travel is required up to 20-30%.

Experience, knowledge and skills:
• Educated to degree level or equivalent in a scientific discipline
• Previous experience of pharmaceutical clinical trial experience
• CRA experience is highly desired
• Oncology experience is desirable
• Excellent verbal, written, interpersonal and presentation skills are required
• Must be familiar with routine medical/scientific terminology
• Must be proficient with Word, PowerPoint, and Excel
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable
• Must be able to participate in departmental or interdepartmental strategic initiative under general supervision

Company

Planet Pharma was founded by a dedicated team of professionals with extensive experience supporting the pharmaceutical, biotechnology, and device industries.

Our goal is to create an organization that strengthens the employer-employee dynamic by connecting clients with talent. This results in making staffing more personal and creating enduring, valuable relationships. We value communication with our clients and make it our priority to have the hiring process be as fast and successful as possible.

We leverage cutting-edge technology and flexible service delivery models that provide efficient, personalized solutions for your business.

Our global headquarters is in Northbrook, IL and branch offices are based across the United States and Europe.

Company info
Website
Telephone
+44 203 868 1000
Location
10 Greycoat Place
London
England
SW1P 1SB
United Kingdom

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