Clinical Scientific Expert

Location Dublin
Job Type Contract
Salary Negotiable
Reference CM23012024_1706028672
Duration 6 months

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.