Senior Clinical Study Management Associate job in England

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Contract

Discipline: Project/Study Manager (CSM/CPM)

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

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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