Role Overview for VP, Clinical Data Management with a Biopharma Firm – Raleigh, NC
JRG Partners is proud to partner with a pioneering, research-driven biopharmaceutical organization in their search for a visionary Vice President of Clinical Data Management. Located in the vibrant Research Triangle Park area of Raleigh, NC, our client is at the forefront of developing life-changing therapies for patients with unmet medical needs.
This executive leadership role is a pivotal opportunity to shape the future of clinical data strategy and operations within a dynamic and rapidly growing company. The VP, Clinical Data Management will be the enterprise-level leader responsible for providing strategic direction, operational oversight, and inspirational leadership to the entire clinical data management (CDM) function. You will be accountable for the integrity, quality, and timeliness of all clinical trial data across a diverse and exciting therapeutic portfolio.
This is more than a management position; it is a strategic role that will influence the entire clinical development lifecycle. The ideal candidate is a forward-thinking expert who can harmonize cutting-edge technology with robust processes and regulatory compliance. You will be tasked with building and scaling a world-class CDM department, fostering a culture of excellence, innovation, and collaboration.
Reporting directly to the Chief Medical Officer, you will serve as the company’s ultimate subject matter expert on all aspects of clinical data, from collection and cleaning to storage and submission. Your leadership will directly impact the speed and success of our client’s clinical programs, ultimately accelerating the delivery of novel treatments to patients worldwide. If you are a seasoned data management leader with a passion for science and a track record of transformative leadership in the biopharma industry, we invite you to explore this career-defining opportunity.
Key Responsibilities of VP, Clinical Data Management with a Biopharma Firm – Raleigh, NC
Strategic Leadership & Vision
Develop and execute a comprehensive, long-term strategic vision for the Clinical Data Management department that aligns with the company’s overall clinical development and corporate objectives. Proactively identify industry trends, emerging technologies, and new methodologies to ensure the organization remains at the cutting edge of data management practices.
Operational Excellence & Oversight
Provide executive oversight for all CDM activities across all phases of clinical trials, from study start-up and database design to data cleaning, query management, and database lock. Ensure the timely delivery of high-quality, reliable, and statistically sound data for analysis and regulatory submissions.
Team Development & Mentorship
Lead, mentor, and develop a high-performing team of CDM professionals. Foster a collaborative, inclusive, and innovative culture. Responsible for organizational design, resource planning, talent acquisition, performance management, and professional development for the entire department.
Process & System Optimization
Drive the continuous improvement of CDM processes, Standard Operating Procedures (SOPs), and systems to enhance efficiency, quality, and compliance. Lead the evaluation, selection, and implementation of advanced data management technologies, including Electronic Data Capture (EDC), ePRO/eCOA, and data visualization tools.
Quality & Regulatory Compliance
Ensure all data management activities are conducted in strict adherence to internal SOPs and external regulations, including GCP, ICH guidelines, and FDA 21 CFR Part 11. Serve as the primary point of contact for CDM during regulatory inspections and audits, ensuring the team is always audit-ready. Uphold the highest standards of Good Clinical Data Management Practices (GCDMP).
Cross-Functional Collaboration
Act as a key strategic partner to other functional leaders, including Clinical Operations, Biostatistics, Statistical Programming, Pharmacovigilance, and Regulatory Affairs. Ensure seamless data flow and clear communication channels to support integrated and efficient clinical development programs.
Vendor & CRO Management
Provide strategic oversight of data management vendors and Contract Research Organizations (CROs). Lead the selection process, contract negotiations, and governance of these external partners to ensure they meet quality, timeline, and budget expectations.
Financial & Resource Management
Develop and manage the annual departmental budget, ensuring optimal allocation of financial and human resources to meet portfolio demands. Provide accurate forecasting and tracking of project costs and timelines.
Data Governance & Standards
Champion and enforce enterprise-wide data standards, including the implementation and use of CDISC standards (e.g., SDTM, CDASH). Establish robust data governance policies to ensure data integrity, security, and traceability throughout the data lifecycle.
Requirements for the VP, Clinical Data Management with a Biopharma Firm – Raleigh, NC
Educational Background
A minimum of a Bachelor’s degree in a life science, computer science, or related field is required. An advanced degree (Master’s, PhD, PharmD) is highly preferred.
Professional Experience
A minimum of 15 years of progressive experience in Clinical Data Management within the pharmaceutical, biotechnology, or CRO industry. At least 8-10 years of experience in a leadership role with significant people management and strategic responsibilities.
Leadership Acumen
Demonstrated experience in building, leading, and scaling a successful Clinical Data Management function. Proven ability to inspire and motivate teams, manage performance, and develop talent.
Technical Expertise
In-depth, expert knowledge of the end-to-end clinical data management process. Extensive experience with major EDC systems (e.g., Medidata Rave, Veeva Vault EDC) and other clinical trial technologies. Deep understanding and practical application of CDISC standards (CDASH, SDTM, ADaM) are essential.
Regulatory Knowledge
Comprehensive understanding of global regulatory requirements and guidelines, including ICH-GCP, FDA 21 CFR Part 11, and GDPR. Experience successfully hosting or participating in regulatory inspections (e.g., FDA, EMA) is required.
Strategic Thinking
Proven ability to think strategically, anticipate future trends, and translate vision into actionable plans. Experience developing and implementing departmental and cross-functional strategies.
Communication Skills
Exceptional written and verbal communication skills. Ability to effectively articulate complex concepts to diverse audiences, from technical teams to executive leadership and external partners.
Vendor Oversight
Significant experience in the selection, management, and oversight of CROs and other third-party data management vendors.
Benefits & Perks Offered
Our client is committed to investing in their employees and offers a highly competitive and comprehensive benefits package designed to support your health, well-being, and financial security. As a key member of the executive team, you will be eligible for:
Competitive Compensation
A highly attractive base salary, annual performance-based bonus, and a significant long-term incentive package (stock options/RSUs).
Comprehensive Health Coverage
Premium medical, dental, and vision insurance plans for you and your eligible dependents, with low employee contributions.
Retirement Savings
A robust 401(k) plan with a generous company match to help you plan for your future.
Work-Life Balance
A generous paid time off (PTO) policy, including vacation, sick leave, and company holidays, plus a flexible work environment.
Family Support
Comprehensive parental leave policies to support growing families.
Professional Growth
A strong commitment to your professional development with support for attending industry conferences, workshops, and continuing education.
Relocation Assistance
A comprehensive relocation package is available for the successful candidate.
On-Site Amenities
Access to a modern campus with various on-site amenities to enhance your workday.
How to Apply
This is a unique opportunity to make a significant impact on a growing biopharmaceutical company and the patients it serves. If you possess the requisite experience, strategic mindset, and leadership qualities, we encourage you to apply for this confidential search.
To express your interest, please submit your resume and a cover letter. JRG Partners is managing this search exclusively on behalf of our client. For more information about our expertise in this area, please visit the JRG Partners’ Life Sciences & Healthcare practice page. We look forward to reviewing your qualifications.
