Senior Clinical Study Management Associate
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.
- 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)
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.