Clinical Trial Associate

The Role

PE Global are recruiting for a Clinical Trial Associate for our pharmaceutical client based in Dublin CC. This is an initial 6 -month contract role. Hybrid working options.

Job Responsibilities

• Perform high quality clinical data review and identify clinical data insights through patient level review and trends analysis, supporting Interim Analysis, Database and Post Lock activities and facilitate resolution of clinical data issues.
• Collaborate with relevant line functions to enhance the quality of clinical data review/insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review.
• Contributes to the development the Data Review/Quality Plan (DRP/DQP) and data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study.
• In conjunction with the relevant line functions, may contribute to Case Report Form (CRF) development, and support the implementation of data capture tools.
• Contribute to and facilitate data review process improvements e.g. identification of delinquent/redundant reports and/or implementation of innovative data analysis processes and tools.
• May contribute (in collaboration with relevant line functions) to the development of study-level documents, including clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers. In collaboration with relevant line functions, review/write clinical trial documents for study CSR activities, and publications.
• Produce training materials and provide training to iCTT.
• Support/present at study level meetings (Investigator Meetings, Data Monitoring Committee (DMC) meetings or others), as required.

Educations & Experience

• Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. Master’s, PharmD, MPharm, PhD, MBBS, BDS, MD strongly preferred.
• Must have fluent English.
• Ideal Background (Pharma)

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up-to-date CV to aisling.oleary@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****