Clinical Trials Management Associate

A global leading pharmaceutical company is seeking a Clinical Trials Associate to join their team in Uxbridge, UK on a contract basis.

Job Role:

• Plays a vital role in successful implementation and support of important Collaborative (CO) and Investigator-Sponsored Research (ISR) projects.
• Serves as the key operational contact with external investigators and internal stakeholders.

Job Responsibilities:

• Evaluates scientific proposals or protocols to identify logistical, regulatory and safety elements and implications.
• Proactively identifies operational challenges and in collaboration with senior team members provides and implements solutions to ensure studies remain on track.
• Maintains efficient collaboration with companys Clinical Contracts and Finance (CCF) team and external investigator/study representative to ensure contracts are executed in a timely manner.
• Supports study drug planning and shipping activities with Materials & Logistics.
• Communicates and collaborates with other functional groups including but not limited to Medical Affairs, Regulatory Affairs, CCF, Materials and Logistics (M&L), and Drug Safety and Public Health (DSPH) to ensure efficient management of study activities.
• Forecasts, tracks and reports CO and ISR milestones, as well as verifies completeness of the study milestones prior to invoice payment.
• Provides monthly study updates to the appropriate internal stakeholders.
• Ensures all budget or drug supply modifications are appropriately approved, documented and tracked.
• Implements working processes to promote high quality, efficient, and compliant systems for Late Phase research management.
• Supports and implements Clinical Operations Quality Initiatives.
• Maintains internal Clinical Operations and Medical Affairs databases and clinical study data and document repositories.
• Performs administrative duties in a timely manner as assigned.
• Provides administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
• May monitors fairly routine study sites, performing routine data collection, source data verification, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
• Under supervision may assist in development and review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports.

Knowledge, Skills and Experience

• Typically requires a BSc in a relevant scientific discipline and relevant clinical experience in the pharmaceutical or health care industry or equivalent.
• Excellent planning, time management, organizational, and administrative skills.
• Demonstrates core values of strong teamwork and accountability with ability to prioritize competing timelines and deliver excellent results.
• Good knowledge and understanding of ICH GCP, FDA and EMEA regulations and guidelines applicable to post-authorization studies.
• Must be proficient with MS Word, PowerPoint, Outlook, and Excel.
• Must be familiar with routine medical/scientific terminology.
• Must be able to participate in departmental or interdepartmental strategic initiative under general supervision.
• Must be able to contribute to SOP development.

To Apply:

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 call Jack O'Neill on +44 203 846 0646 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.

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