Job Description
Our client, a young commercial stage biopharmaceutical company based in Dublin who are progressing a number of assets through phase I-III clinical development stages, have now approved a permanent role of Senior Clinical Research Associate. This is a permanent role based in Dublin, with some flexibility for the right candidate.
Key Remit: This hire with provide oversight of all the Clinical Operational activities for Global Clinical Trials where responsibilities have been transferred by this development company to CROs and other vendors, ensuring compliance with GCP and company SOPs to meet close-out timelines and budgets.
Person fit: Ideal candidate will be an experienced CRA in the pharma / biopharma industry, who is experienced in providing oversight of outsourced global Phase I-III trials, ensuring compliance with all cGCP, cGLP, etc. requirements.
Responsibilities of Senior CRA:
Complete responsibility for all aspects of project life cycle; from protocol writing to close out, in accordance with applicable legislation and ICH / GCP guidelines.
Manage CROs, i.e. outsourced clinical trials, including; tendering process, quotations and selection process, to deliver clinical trials / programs to company timelines and within budgets.
Monitor/audit both CROs and related vendors onsite.
Provides close oversight of the functions of the CRO/vendors to ensure successful completion of the clinical operations functions within the trials/program.
Establishes/negotiates timelines and budgets for study execution and completion of clinical activities.
Requirements of Senior CRA:
Bachelor's Degree in Science, healthcare or similar.
4+ years' experience as Clinical Project Manager with Phase II / III trials in either CRO or pharmaceutical company; ideally with vendor management experience (CRO, central labs, etc.).
Broad therapeutic experience in close-out of Clinical Trials through project closeout, in line with timelines.
Experience participating in Clinical Operations related projects with cross-functional stakeholders.
Proven ability to build and maintain effective relationships with others and establish collaborative partnerships with internal and external stakeholders.
Flexible in reacting to changing priorities in projects without compromising timelines and/or quality.
Fully conversant with the use of EDC in clinical trials.
A willingness to deal with international teams working in different time zones.
Excellent communication, organization and decision-making skills.
Strong working knowledge of MS Office and Outlook.
Some international travel may be required (<10%).
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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