Senior Clinical Study Management Associate

Highly Competitive
  1. Contract
  2. Project/Study Manager (CSM/CPM)
  3. United Kingdom
England
Posting date: 13 Nov 2020
34154

An attractive job opportunity has arisen for a Clinical Study Management Associate to temporarily join a large pharmaceutical company. This role will include assisting with Study start up, Data Management and completion of clinical trials within expected timelines.

Job Responsibilities

  • 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/GCP guidelines.
  • Assist with the management of key study parameters (e.g. start-up activities, enrollment, site management, data collection, data reviews, site feasibility, database lock, etc.) and proactively identify solutions within the clinical team when issues arise.
  • Assist with the development and review of informed consent forms, case report forms, study manuals, and other supporting clinical trial materials.
  • Assist with evaluating, selecting, and managing clinical study sites.
  • Assist in the evaluation, oversight and management of CROs and other vendors and systems.
  • Assist with negotiation and co-management of contracts/budgets with CROs and other vendors.
  • Provide input to and co-manage project objectives to meet timelines and deliverables.
  • Responsible for tracking/maintaining study metrics/progress and providing routine study updates via the Clinical Operations Manager, to the project team/sub-team.
  • Assist with the analysis and development of action plans to address issues with investigational sites and/or CROs.
  • Assist with creation of study specific tools and manuals to ensure timeliness, standardization and control of data quality.
    * Assist in training/mentoring new team members on specific study processes, as required/appropriate.
  • Review and negotiate clinical site study contracts and budgets.
  • Assist with the planning, coordination and presentations at Investigator Meetings and CRA Training meetings as requested.
  • Support internal and regulatory audits of clinical trial sites and vendors and assist with resolution of audit findings.
  • Assist and provide input to the creation/revision/review of departmental SOPs.

Skills & Requirements

  • Bachelors/Master's degree (or equivalent) in a health care or other scientifically-related field
  • Minimum of 5 years clinical research experience and at least 3 years' experience as an in-house Ops Associate in a biopharmaceutical company or CRO.
  • Previous experience working on global oncology clinical trials is strongly preferred
  • Site monitoring experience desirable (conducting Qualification, Initiation, Interim and Close-Out Visits or Sponsor Oversight Visits).
  • Good working knowledge of FDA/EMA regulatory requirements and ICH/GCP guidelines
  • Ability to work as part of a team/active team participant as well as alone
  • Computer proficiency (MS Word, Excel, PowerPoint)

To Apply

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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