Clinical Data Review Lead

Medical Data Review Specialist

We are seeking a highly skilled Medical Data Review Specialist to join our team. The ideal candidate will have experience in clinical data sciences and possess strong leadership skills.

About the Role:

The Medical Data Review Specialist will be responsible for providing expert skills as part of a Medical Data Review team to provide efficient, quality Medical Data Review products that meet customer needs. This includes conducting in-stream data trend analysis, ensuring data quality focus, defining data capture requirements, and representing clinical data scientist at multi-disciplinary team meetings and external meetings.

Key Responsibilities:

1. Data Quality Management: Conduct in-stream data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data)
2. Audit Readiness: Ensure data quality focus to audit readiness with Clinical Compliance and Systems Validation Compliance.
3. Data Capture Requirements: Define data capture requirements in line with protocol and reporting needs.
4. Clinical Expertise: Represent clinical data scientist at multi-disciplinary team meetings and external meetings.
5. Customer Relationships: Maintain strong customer relationships
6. Performance Tracking: With guidance, track service performance and provide leadership to identify root causes of issues and implement remedial actions
7. Compliance Issues: Ensure timely follow-up and resolution of compliance issues
8. Subject Matter Expert: Serve as Subject Matter Expert (SME)
9. Process Improvement: Continuously look for opportunities to improve efficiency of tasks and quality of deliverables
10. Therapeutic Area Training: Provide therapeutic area/indication training for the project clinical team.
11. Team Management: Manage staff in accordance with organization's policies and applicable regulations. appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.

Qualifications and Skills:

1. MBBS/MD: MBBS/MD is mandatory.
2. Equivalent Combination: Equivalent combination of education, training and experience in lieu of degree Req
3. Clinical Data Sciences Experience: Experience in clinical data sciences at a CRO, pharmaceutical company or other medical environment with demonstrated leadership experience Req
4. Clinical/Medical Data Knowledge: Good understanding of clinical/medical data
5. Proactive Identification: Proven expertise in the proactive identification of issues
6. Leadership and Planning: Demonstrated ability to plan, organize and manage resources to bring to successful completion specific study or project goals and objectives in accordance with defined quality and time based metrics
7. Matrix Team Environment: Proven ability to work within a matrix team environment requiring minimum level of supervision
8. Attention to Detail: Attention to detail
9. Interpersonal and Analytical Skills: Interpersonal and analytical skills,
10. Representation: Ability to represent clinical data scientist at multi-disciplinary team meetings and external meetings
11. Medical Terminology Knowledge: Knowledge of Medical Terminology, Pharmacology, Anatomy, and Physiology
12. Operational Focus: Must have Medical but also an operational focus towards metrics and status information to take the appropriate actions to resolve
13. Communication and Teamwork: Excellent communication, interpersonal, customer service, and teamwork skills
    • Excellent organizational and problem-solving skills
14. Project Management and Coaching: Excellent project management skills and coaching skills
15. Autonomy and Prioritization: Ability to work with minimal supervision, using available resources
16. Multiple Projects: Ability to work on multiple projects and manage competing priorities
17. Customer Focus: Strong customer focus skills
18. Relationship Building: Ability to establish and maintain effective working relationships with coworkers, managers and clients