Clinical Study Management Associate

£0.00 - £48000.00 per annum
  1. Permanent
  2. Project/Study Manager (CSM/CPM)
  3. United Kingdom
Cambridge, Cambridgeshire
Posting date: 01 Apr 2019
CR.MP.22472_1554118413

ProClinical is partnering with a biopharmaceutical company to advertise a vacancy for a Clinical Study Management Associate position. The organisation focuses on developing cancer treatments and prides itself on its extensive pipeline of products in development. Based in Cambridge, this is an exciting opportunity to work with an internationally recognised organisation.

The Clinical Study Management Associate will assist in 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/GHP guidelines.

Job Responsibilities:

  • 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 with the evaluation, oversight, and management of CROs and other vendors and systems.
  • Providing input to and co-managing 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 the 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, and study design and/or study conduct issues.
  • Reviewing and negotiating clinical site contracts and budgets.
  • Assisting with the planning, coordination, and presentations at Investigator Meetings and CRA Training meetings as requested.
  • Attending/accompanying the CRO personnel on the various site visits as applicable, sponsoring oversight visits as required/requested.
  • Supporting internal and regulatory audits of clinical trial sites and vendors and assisting with the resolution of audit findings.
  • Assisting with the management of internal trial master files.
  • Assisting and providing input to the creation/revision/review of departmental SOPs.

Skills and Requirements:

  • Demonstrable experience in a similar role.
  • Experience and knowledge of ICH/GCP guidelines.
  • A thorough understanding of compliance protocols.
  • 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.

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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