Senior Clinical Trial Management Associate

Proclinical are recruiting a Senior Clinical Trial Management Associate for a biotech corporation. This role is on a contract basis and is located in Uxbridge with flexible working available. The client is focused on engineering novel remedies for life-threatening illnesses.

Responsibilities:

• You serve as the main operational contact with external investigators and internal stakeholders.
• Assess scientific proposals or protocols to classify logistical, regulatory and safety elements and inferences.
• Handle allotted studies by establishing strong partnerships with external investigators and collaborators to ensure CO and ISR Agreements for financial or the company's product support are managed in a timely manner and to a high quality.
• Proactively recognise operational challenges and in partnership with senior team members offering and applying solutions to guarantee studies remain on track.
• Sustain effectual association with the company's Clinical Pricing and Finance teams and external investigator/study representative to ensure contracts are implemented in a timely manner.
• Responsible for supporting study drug preparations and shipping activities with the company's Clinical Supply Chain Management (CSCM) teams.
• Correspond and working alongside other functional groups within the company, involving but not limited to; Medical Affairs, Regulatory Affairs, Clinical Pricing - Development Business Operations, (DBO), Clinical Supply Chain Management (CSCM), and Global Patient Safety (GLPS) to certify effective management of study activities.
• Accountable for forecasting, tracking and reporting CO and ISR milestones within the company's Clinical Trial Management Systems (CTMS) systems, as well as authenticate completeness of the study milestones prior to invoice payment.
• Deliver monthly study updates to the suitable internal stakeholders.
• Guarantee all budget or drug supply modifications are aptly permitted, documented and tracked.
• Execute working processes to promote high quality, efficient, and compliant systems for Late Phase research management.
• The ideal candidate will support and apply Clinical Operations Quality Initiatives.
• Uphold internal Clinical Operations and Medical Affairs databases, tracking systems and clinical study data and document repositories.
• Conduct administrative duties in a timely manner as allocated.

Skills & Requirements:

• Must be eligible to work in the UK.
• This role characteristically necessitates a BSc in an applicable scientific subject and pertinent clinical experience in the pharmaceutical or health care industry or similar.
• Exceptional planning, time management, organisational, and administrative skills.
• You can exhibit the core values of strong teamwork and responsibility with ability to prioritise competing timelines and deliver excellent results.
• Learning ability with proven flexibility essential to maintain a fast pace.
• Brilliant verbal, written, interpersonal and presentation skills are required for this role.
• Tenacity and perseverance to ensure a high level of customer service.
• Strong capacity to maintain internal/external networking and cross-functional collaboration.
• Display a high sense of urgency and commitment to brilliance in the successful implementation of deliverables.
• Must be able to prioritise multiple tasks, and accomplish goals using well-defined instructions and procedures.
• Good knowledge and understanding of ICH GCP, FDA and EMEA regulations.
• Familiar with MS Word, PowerPoint, Outlook, and Excel.
• Proficient with routine medical/scientific terminology.
• Capable of partaking in departmental or interdepartmental strategic initiative under general supervision.
• Can contribute to SOP development as required.

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 Matthew Pike on +44 207 4400 639.

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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