Job Description
Our client, a global pharmaceutical company with renowned reputation as a market leader in their categories, now seek to appoint a Clinical Trials Specialist for their newly created operating from their Dublin office operating and working as part of a global team.
The successful candidate will support the development and implementation of a global clinical development group and the delivery of clinical projects through development i.e. Phase I – IV.
The ideal candidate will be experience in oversight of CRO interactions from CRA / CTS Study Coordinator perspective, ensuring that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets.
Responsibilities of Clinical Trial Specialist:
Assists with the study project plan development/review, including timeline and budget
Coordination of CROs interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files)
Assist with protocol, CRF development, Clinical Study Report preparation, etc.
Performs manual, in-house review of CRF data in clinical database for completeness and accuracy.
Prepares metrics and updates for internal review, as assigned.
Proactively identifies potential study issues/risks and recommends/implements solutions.
Prepares and/or reviews/approves study-related documents.
Participates in the development, review and implementation of departmental SOPs and processes
Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings
Reviews site study documents, investigator contracts, and site payments
Participates in the selection, training and evaluation of study personnel to ensure the efficient operation of function
Requirements for Clinical Trial Specialist:
Bachelor of Science degree is preferred.
3+ years of related clinical trial management experience (e.g. CRA, study coordinator) in the pharmaceutical industry or clinical setting.
Experience in managing outside vendors (e.g. CROs and other vendors).
Strong knowledge and experience of clinical research operations, including interpretation and implementation of EU regulations/ICH guidelines, is required.
Candidate will be a superb communicator of technical and scientific information and possess excellent interpersonal skills & strong organization skills.
Strong attention to detail is required.
Some EU travel maybe required (<5%).
Please contact Larry on 01 – 2302400 / larry@rftgroup.ie
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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