Quality , Science, Pharmaceutical & Food
Clinical Trials Management Associate
- Dublin City Centre
PE Global are currently recruiting for a Clinical Trials Associate for a client site in Cork –
Clinical Trial Management Associate, Clinical Operations -12 month initial contract
The Clinical Operations team in Dublin is a pivotal function of the Paediatric Centre of Excellence in Dublin and is responsible for the management and execution of Paediatric Clinical Trials, across all therapeutic areas, around the world. In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Clinical Operations ensures that all clinical trial activities are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high-quality clinical data to support global registration and commercialization of products.
The Clinical Trial Management Associate will be a valued member of the Clinical Operations team in Dublin.
He/She will work closely with the Clinical Trial Manager as a member of a global or regional study team, to manage components of the clinical trial, with an ability to manage vendors and independently lead part of a study.
- Provides administrative assistance in site selection, study implementation and on-going coordination
- of study sites, either directly or via CROs.
- May monitor or co-monitor study sites to ensure correct study procedures according to SOPs
- and protocol procedures, and review of routine regulatory documents/files in compliance with
- protocol, regulatory requirements, SOPs and Monitoring plan, as required.
- Under supervision, may assist in review of Protocols, Informed Consents, and Case Report Forms,
- monitoring plans, abstracts, presentations, manuscripts and Clinical Study Reports.
- Review of trip reports generated by CRO CRAs. May resolve routine monitoring issues.
- May lead a cross-functional team to accomplish study objectives.
- Assists in the management of CROs and Vendors as required.
- Participates in frequent cross-functional review of clinical study data and other metrics to ensure
- data integrity.
- Assists in preparation of safety, interim and final study reports, including resolving data
- Responsible for filing necessary documents in the electronic trial master file (TMF), and for leading
- regular cross-functional reviews of the TMF.
- May contribute to SOP development.
- Assists with the preparation and organization of international investigator meetings.
- Performs administrative duties in a timely manner as assigned.
- Tracks and prepares study information using Clinical Operations databases and spreadsheets.
- Travel is required.
Knowledge, Experience & Skills:
- BSc or BA in a relevant scientific discipline or RN qualification.
- Minimum one-year relevant clinical trial experience in the pharmaceutical industry.
- CRA experience preferred.
- Excellent verbal, written, interpersonal and presentation skills are required.
- Must be familiar with routine medical/scientific terminology.
- Must be able to participate in departmental or interdepartmental strategic initiatives under general
- supervision as required.
- Must be able to prioritise multiple tasks, plan proactively and accomplish goals using well defined
- instructions and procedures.
- Knowledge of FDA and/or EMEA Regulations, ICH Guidelines and GCP governing the conduct of
- clinical trials.
- Working knowledge and experience with Word, PowerPoint and Excel.
Interested candidates should send their CV to Audrey.firstname.lastname@example.org or call 0214297900