Job Description
Young vibrant entrepreneurial pharmaceutical company based in Dublin, now seeks a Lead CRA contractor for circa 6 month timeframe to support a pivotal Phase III trial in rare disease, while supporting and advancing the companys' Clinical Development activities in the Pharmaceutical Industry.
Person fit: Ideal candidate will be; a dynamic individual, who is self-driven and capable of working on their own initiative in a start-up environment. This hire must be willing to travel across mainland Europe.
Responsibilities of Lead CRA, EU Region:
Support all aspects of project life cycle; from protocol writing to close out, in accordance with applicable legislation and ICH / GCP guidelines.
Interacts with investigators and study coordinators through frequent communication (written and verbal) and maintains effective management of study sites.
Prepares metrics and updates for internal review, as assigned
Proactively identifies potential study issues/risks and recommends/implements solutions
Work in conjunction with CROs, i.e. outsourced clinical trials, to deliver clinical trials / programmes to company timelines.
Provides close oversight of the functions of the CRO/vendors to ensure successful completion of the clinical operations functions within the trials/program.
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
Establishes/negotiates timelines and budgets for study execution and completion of clinical activities.
Requirements of Lead CRA, EU Region:
Bachelor's Degree in Science, healthcare or similar is preferred.
5+ years' experience as CRA / Senior CRA, ideally in Pharmaceutical industry.
Strong knowledge and experience of clinical research operations, including interpretation and implementation of EU regulations/ICH guidelines, is required.
Broad therapeutic experience, ideally experienced in rare-diseases.
Ability to provide clinical expertise to a clinical development in a specified product area or project.
Candidate will be a superb communicator of technical and scientific information and possess excellent interpersonal skills & strong organization skills.
International and domestic travel is required.
Please contact Larry on 01-2302400 / +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