Contract Clinical Study Management Associate

A biopharmaceutical company that focuses on developing cancer treatments is currently recruiting for an experienced Contract Clinical Study Management Associate to join their expanding team in the UK. This is an exciting time to join this company who operate across the United States, Europe, and other international markets and have an extensive pipeline of products under development.

Job Responsibilities:

• Managing all aspects of clinical trials to ensure that studies are completed on time, within budget, and in compliance with SOPs, FDA/EMA regulations, and ICH/GCP guidelines.
• Assisting with the management of key study parameters (e.g. start-up activities, enrolment, site management, data collection, data reviews, site feasibility, database lock, etc.), and proactively identifying solutions within the clinical team when issues arise.
• Assisting with the development and review of informed consent forms, case report forms, study manuals, and other supporting clinical trial materials.
• Assisting with evaluating, selecting, and managing clinical study sites.
• Assisting in the evaluation, oversight, and management of CROs, other vendors, and systems.
• Assisting with negotiation and co-management of contracts/budgets with CROs and other vendors.
• Providing input to and co-manage project objectives to meet timelines and deliverables.
• Tracking/maintaining study metrics/progress and providing routine study updates via the Clinical Operations Manager, to the project team/sub-team.
• Assisting with the analysis and development of action plans to address issues with investigational sites and/or CROs.
• Assisting with creation of study specific tools and manuals to ensure timeliness, standardization and control of data quality.
• Assisting in training/mentoring new team members on specific study processes, as required/appropriate.
• Serving as a primary contact for Investigator sites.
• Reviewing and providing input to regulatory documents (Clinical Trial Application documents/CEC application documents/ IRAS/R&D forms).
• Participating in the analysis and reporting of safety issues, patient care issues, study design, and/or study conduct issues.
• Reviewing and negotiating clinical site study contracts and budgets.
• Assisting with the planning, coordination, and presentations at Investigator Meetings and CRA Training meetings as requested.

Skills and Requirements:

• Bachelor's degree.
• 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.

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 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.

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