Director, Clinical Data Management

Role Summary

We are seeking a highly motivated Director of Clinical Data Management (CDM) to lead study-level data management activities in support of our oncology clinical development programs. This individual will serve as the CDM lead for one or more clinical trials, responsible for the planning, execution, and oversight of data management activities in collaboration with internal stakeholders, including ex-US DM team and external partners (e.g., CROs, technology vendors). This is an exceptional opportunity to contribute directly to the success of high-impact oncology trials in a dynamic and collaborative environment. The role will report to the Head of Clinical Data Management and may evolve to include line management responsibilities as the organization grows.

Responsibilities

• Work closely with Clinical Operations, Biostatistics, Medical, and Regulatory Affairs to align on trial objectives, timelines, and data expectations.
• Act as the data management point-of-contact during study planning, conduct, and closeout phases.
• Lead Data Working Groups and cross-functional data review meetings and ensure data quality is maintained throughout the study.
• Contribute to the development of clinical trial protocols, and statistical analysis plans (SAPs) from a data management perspective.
• Collaborate with and provide oversight of NUVB ex-US DM collaborators, CROs and third-party vendors, ensuring the quality and timeliness of deliverables.
• Participate in vendor selection and contracting activities; contribute to the development of vendor performance metrics.
• Ensure effective communication between vendors and internal teams to proactively address data-related issues.
• Contribute to the development and continuous improvement of data management processes, SOPs, and standards within the organization.
• Support regulatory inspections and audits by providing documentation and subject matter expertise as needed.
• May lead or participate in data-focused initiatives, such as implementing new data review tools and R shiny apps, standardizing data review workloads, or adopting novel data sources (e.g., ePRO, wearables).
• As the team grows, may provide mentorship or line management to junior CDM staff or contractors.
• Participate in training, onboarding, and professional development of new team members.

Qualifications

• Bachelor’s degree in life sciences, data science/statistics/math, computer science, health informatics, or related field required; advanced degree preferred.
• 8+ years of clinical data management experience in the biotech, pharmaceutical, or CRO industry.
• 3+ years of experience leading data management activities for global clinical trials (oncology experience highly preferred).
• Strong working knowledge of clinical data systems (preferably Medidata Rave) and CDISC standards (SDTM, CDASH).
• Experience managing third-party vendors and overseeing outsourced data management activities.
• Thorough understanding of GCP, ICH, and relevant regulatory guidelines.
• Excellent organizational, communication, and problem-solving skills.
• Comfortable working in a fast-paced, hands-on environment with the ability to pivot as priorities evolve. Prior experience working in a small biotech or startup environment is highly desirable.
• Familiarity with complex data types (e.g., imaging, genomics, digital endpoints) in oncology trials is desirable.
• Demonstrated ability to balance strategic thinking with hands-on execution.
• Experience supporting regulatory submissions (e.g., NDA, BLA) is a plus.

Skills

• Problem-Solver - As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
• Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
• Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
• Emotional intelligence, curiosity, and a knack to figure out a way to build something better
• Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders.
• Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity.
• Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.