Description
We are seeking a Clinical Data Review Lead to oversee the review of clinical data for medical completeness, scientific accuracy, and coding consistency. You will be responsible for line management of a group of individuals and have shared accountabilities for service resulting in high-quality medical data review.
Key Responsibilities:
- Provide regular meetings with employees to discuss important business topics, workload, support needed, and performance development
- Perform work allocation and resource management duties
- Ensure compliance with corporate policies, procedures, and guidelines
- Oversee the process implementation and ongoing review and querying of critical clinical/safety data
- Ensure seamless and complete clinical data review
- Support scientists in day-to-day handling and querying of clinical/safety data
- Ensure effective cross-functional collaboration between staff and stakeholders
- Act as a trailblazer in clinical projects and a role model for project leaders/project experts
- Mentor and train junior staff to ensure consistent processes and efficient review of critical medical/safety data
Requirements:
- Advanced university degree in a medical/life science field
- Minimum 3 years of experience working in clinical research, pharmacovigilance, and/or safety and clinical data review methodology
- In-depth understanding of the clinical study and drug development process and GCP/ICH guidelines
- Proven project management capabilities and ability to manage change, risks, priorities, and performance targets
- Excellent knowledge of spoken and written English and computer proficiency
- Line management experience and ability to effectively lead complex non-drug projects in a worldwide environment