Job Description
Our client is a fast growing highly profitable biopharmaceutical company with an exciting drug development pipeline, now has a newly created permanent role of Senior Clinical Trial Specialist. This role will support a global program, with oversight for European & ROW aspects in partnership with US colleague.
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.
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 is preferred, 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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