Job Description
Our client is a fast growing highly profitable biopharmaceutical company with an exciting pipeline of drug compounds at an advanced stage in research, now has a newly created permanent role of Senior Clinical Trial Specialist.
The successful candidate will work within a global team supporting clinical operations activities and provide clinical expertise to the delivery of clinical study projects - support vendor/CRO relations and activities.
This role will require travel circa 15-20% at a maximum, the majority of which is within EU region.
The main focus of this role: is 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.
Responsibilities of Senior 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 and strategy development, Clinical Study Report preparation, NDA submission, 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
Prepares and/or reviews/approves study-related documents (e.g., Monitoring Plan, Lab Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines)
Manages clinical monitoring activities ensuring compliance with GCP and applicable regulations
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 Senior Clinical Trial Specialist:
Bachelors Degree in Life Science or Nursing is preferred.
4+ years of related clinical trial management experience (e.g. CRA, study coordinator) in the pharma/biotech industry or clinical setting.
Experience in managing outside vendors, e.g., CROs and other vendors.
Broad therapeutic experience, including Rare-diseases, Oncology, Cardiovascular, Neurology, GI, etc.
Strong knowledge and experience of clinical research operations, including interpretation and implementation of FDA and EU regulations, ICH GCP guidelines, are required.
Candidate will be a superb communicator of technical and scientific information and possess excellent interpersonal skills & strong organization skills.
Proficiency in Microsoft Outlook, Word, Excel, and PowerPoint.
Strong attention to detail and ability to multitask 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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