Title: Director, Clinical Data Management & Compliance
Department: Operations
Status: Full-time, Exempt
Location: Folkestone, UK or Remote U.K
Company Overview
Clinical Outcomes Solutions (COS) is a global research consulting group providing 360° support and services across all facets of clinical outcomes research to assist with value-driven decisions for informing patient care. Our mission is to advance the science of patient outcomes through innovative solutions and deep partnerships with our clients. We are dedicated to transforming clinical outcome assessment (COA) research into a powerful tool for improving patient lives and creating value for our clients. With a passionate commitment to excellence, we strive to drive a measurable impact on patient outcomes and make a meaningful difference in patients’ lives worldwide.
You must submit your resume to HR@clinoutsolutions.com for consideration
Role Summary
Reporting to the Chief Executive Officer, the Director of Clinical Data Management and Compliance will carry out global regulatory and scientific compliance and data driven technology adoptions as well as lead and mentor a small team. The Director is also responsible for leading and developing the company’s Quality Management System. This role offers the chance to work locally and globally alongside company operations and scientific team members.
The Director will also be a leader in the wider team providing functional excellence and talent development and will be integral to the COS mission to be the best-in-class COA research organization in the industry.
Responsibilities
- Provide strategic leadership for global Data Management operations, aligning team performance with company objectives and regulatory standards.
- Lead the development of the company’s Quality Management System (QMS)
- Lead cross-functional collaboration with Research Operations and Scientific teams to ensure timely, compliant, high-quality data deliverables across business units.
- Drive the adoption of best practices and regulatory compliance in research outcomes (GDPR, data integrity, etc.)
- Lead efforts to achieve scientific audit readiness and regulatory compliance through SOP, policy, working practice, and training alignment and documentation excellence.
- Identify potential areas of compliance vulnerability and risk and recommend improvements through leadership of the Quality Assurance team.
- Implement proactive risk mitigation strategies to safeguard data integrity, security and control.
- Represent the company during audits and sponsor requests reinforcing thought leadership and operational transparency.
- Spearhead adoption of advanced EDC systems to enhance data quality and scalable operational efficiency and support business development
- Contribute to operations system solutions selection and implementation
Requirements
- A minimum of a bachelor’s degree in computer science, data science or related areas is required
- A minimum of 12+ years of direct and relevant experience in data management and regulatory audit/compliance in pharmaceutical/healthcare industry
- A minimum of 5 years’ experience directly managing, mentoring, and leading a team of employees.
- Expert understanding and experience of the regulatory environment and regulatory standards and frameworks in US and EU/UK (CDISC, CDASH, ICH GCP, GDPR, HIPPA)
- Highly proficient in EDC systems (Medidata Rave, Veeva Vault, InForm, Medrio),
- Previous experience in a consultancy, professional services environment preferred
- Previous experience in the selection and implementation of systems solutions
- Previous experience with mainstream analytical tools (Microsoft Power BI, Google Analytics 360, Tableau)
- Strong qualitative skills.
- Demonstrated experience in developing innovative solutions to meet sponsor needs
- Able to work in a fast-paced, client-focused environment
- Excellent oral and written communication skills
- Strong interpersonal skills
- Ability to inspire and support others to achieve their own and the company’s strategic goals
…