Job Description
Our client, a young science focused pharmaceutical company, now seek a Clinical Trials Specialist to work closely with various internal team members and vendors as well as clinical study sites to ensure that clinical trials are conducted in a timely fashion and in a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals, and budgets.
Rapid expansion has led to the need to create this Clinical Trials Specialist role, who will be based in their Dublin office. This is a rare opportunity to join a young, exciting clinical-stage pharmaceutical company with strong development pipeline.
Responsibilities of Clinical Trial Specialist:
Assists with the study project plan development/review, including timeline and budget
Manages CRO interactions, including sponsor oversight of operational functional activities (e.g., study management, monitoring, site management, project master files)
Assist with protocol, CRF, Clinical Study Report preparation, etc.
Interacts with investigators and study coordinators through frequent communication (written and verbal) and maintains effective management of study sites
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
Participates in and facilitates CRO/vendor selection process for outsourced activities
Participates in preparation and/or review/approval study-related documents (e.g., Monitoring Plan, Lab Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)
Requirements for Clinical Trial Specialist:
Bachelor of Science degree is preferred.
2+ years of related clinical trial management experience (e.g. CRA, study coordinator) in the pharmaceutical industry, CRO or clinical setting.
Experience in managing outside vendors, e.g., CROs and other vendors.
Broad therapeutic experience is preferred.
Knowledge and experience of clinical research operations, including interpretation and implementation of EU regulations/ICH guidelines, is required.
Ability to provide clinical expertise to a clinical development in a specified product area or project.
Candidate will be a excellent communicator of technical and scientific information and possess excellent interpersonal skills & strong organization skills.
Must display strong analytical and problem solving skills.
Strong attention to detail is required.
Please contact Larry on +353 1 – 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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