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Associate Clinical Study Excellence Scientist

Purpose

The Assoc. CSES is a member of the core study team. The role will serve as a key liaison for the medical aspects of a trial within the study team. It encompasses ensuring the quality and integrity of medical study data and optimization of drug development within the trial's framework. The Assoc. CSES supports the CSES or works independently in less complex trials.

Geographical Scope

Global

Key Responsibilities

You will perform medical oversight of CD&O clinical trials and ensure participant safety and scientific integrity of the study from concept to final report. You can be the clinical representative in the core study team. In this role, you:

• Contribute to the medical sections of the study protocol and other study documents

• Provide input for the medical sections of clinical study reports and annual report documentation

• Perform medical review and analysis of safety data to detect trends and address discrepancies

• Prepare of the safety aggregated report for cross-functional review

• Develop and maintain of the Medical Review Plan (MRP)

• Provide expertise for study tool setup and maintenance (eCRF, eCRF Completion Guidelines, clinical database UAT, data analysis, and visualization systems)

• Support in preparing materials for use in presentations and advisory committee meetings

• Support training on medical aspects of the study to internal and external stakeholders

• Serve as the first point of contact on medical issues of assigned studies

• Ensure GCP compliance in the medical aspects of the study

• Support protocol deviations cross-functional review, as appropriate

• Review CIOMS reports and narratives in the clinical study report (CSR).

• May work with the study team on study site feasibility.

• May participate in expert working groups, project standard teams, and contribute to global process improvement efforts

Value Added

The Assoc. CSES assists to ensure the medical integrity of trial conduct in clinical studies/projects while collaborating effectively with the study team on study deliverables. The Assoc. CSES supports high-quality clinical trials and aims at drug approval.

Contribution Context

Individual Contributor X Team Member X Supervisor Manage Supervisors Team Leader Manage Function / Department

Work Interactions

• Core Study Team

• Global Clinical Lead / Clinical Development Lead/ Early Clinical Lead

• Global Safety Lead

• Data Monitoring Committee / Steering Committee/ Adjudication Committee

• Country Lead Monitor / Clinical Research Associate

Qualifications

Minimum education and experience

• MD, DO, PhD, PharmD, RN with a minimum of 1-2 years of industry experience in a pharmaceutical/biotech business and/or clinical experience

Preferred education and experience

• MD degree is preferred;

• Industry experience is not required but is a plus

Expertise, skills, and characteristics

• Ability to acquire knowledge of different diseases and therapeutic areas

• Proficient in GCP/ICH, FDA, EMA, and other relevant guidelines and regulations

• Proactive, very flexible attitude

• Adapts quickly to change

• Able to work collaboratively across cultures and geographies

• Strong communication skills

Organizational Relationship

• Country Lead Monitor / Clinical Research Associate

Location:

Spain : Cataluña : Barcelona

Division:

Pharmaceuticals

Reference Code:

868143