IRC Recruitment is hiring on behalf of a client for the role of a Clinical Scientific Expert within the pharmaceutical industry.

6 month contract with possibility of Extension

€20/hour PAYE- salary non negotiable

Hybrid working- onsite 3 days per week

Job Purpose:

The Clinical Scientific Expert I (CSE I) plays a vital role in providing clinical and scientific support across all phases of clinical studies, ensuring adherence to established processes and regulatory standards.

Major Activities:

1 Conduct thorough clinical data review, analyze trends, and provide insights for Interim Analysis, Database, and Post Lock activities, focusing on subject safety, eligibility, and data integrity.
2 Contribute to the development of Data Review/Quality Plan (DRP/DQP) and data review strategy, ensuring consistent implementation of protocol elements.
3 Collaborate on Case Report Form (CRF) development and assist in the implementation of data capture tools.
4 Contribute to process improvements in data review, identifying areas for enhancement and implementing innovative analysis processes and tools.
5 Support the development of study-level documents and regulatory submissions, collaborating with relevant functions.
6 Provide support for pharmacovigilance activities if required, such as reviewing and contributing to aggregate reports and patient narratives.
7 Develop training materials and provide training to the Integrated Clinical Trial Team (iCTT).
8 Support and present at study level meetings, including Investigator Meetings and Data Monitoring Committee (DMC) meetings.

Other responsibilities:

1 Develop subject matter expertise in disease areas and clinical data review tools/processes.
2 Contribute to Clinical Development and Analytics (CD&A) initiatives and education projects.

Key Performance Indicators:

- Consistent and accurate clinical data review meeting quality standards and timelines.

- High-quality contributions to study documents.

- Demonstrates the client's Values and Behaviours.

-Impact on the organization:

-High-quality data supports strategic decision-making and health authority submissions, establishing the client as a credible partner in the assigned therapy area.

Ideal Background (Pharma):

Education: Advanced degree in life sciences/healthcare, with a preference for Master’s, PharmD, MPharm, PhD, MBBS, BDS, or MD.

Languages: Fluent in English (oral and written).

Guidant Global is acting as an Employment Business in relation to this vacancy.

Email me jobs like this