Clinical Scientific Expert - 08929 (04/23) - new job in Dublin South, Ireland

SRG are currently seeking a Clinical Scientific Expert for an initial 12 month contract period, partnering with our Client, a Global Pharmaceutical Company. The position will be remote working roles based in Ireland or the UK The purpose of these positions is to provide clinical and scientific support through all phases of a clinical study in line with the relevant regulations.

Role Responsibilities

• Perform high quality clinical data review and identify clinical data insights
• 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.
• Contribute to the development of 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.
• Contribute to Case Report Form (CRF) development and support the implementation of data capture tools.
• Contribute to and facilitate data review process improvements
• Contribute to the development of study-level documents
• Support pharmacovigilance activities
• Produce training materials and provide training
• Support study level meetings
• Develop subject matter expertise (disease area knowledge, clinical data review tools and/or processes).

Qualifications/Preferred Experience

• Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. Master's, PharmD, MPharm, PhD, MBBS, BDS, MD strongly preferred.
• Demonstrable experience in clinical data review
• Good baseline of knowledge and experience in technical skills including familiarity with advanced functionality in excel, EDC systems, data visualisation tools
• Ability to appraise and review data from a clinical perspective including ability to interpret the data and assess the plausibly consistent across panels or an entire dataset.
• Effective verbal and written communication skills.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.