Director, Clinical Data Management

Candidates local to the Warren, NJ area are strongly preferred for our flexible hybrid work model. We welcome applicants who are open to relocating to the area.

About the role

The Director, Clinical Data Management provides strategic and operational leadership and oversight of data management activities to ensure the quality, integrity, consistency, and inspection readiness of clinical databases for subsequent analysis, reporting, and regulatory submissions. This position has a leadership role to proactively develop plans for the utilization of EDC system processes and other clinical data applications that allow for internal control of clinical databases. The role involves defining Sponsor processes and procedures for maintaining clinical data and associated Quality Assurance (QA) and Quality Control (QC) documentation. The incumbent may have supervisory responsibilities for both internal staff and external consultants and may manage direct reports. This position works cross-functionally with various internal departments and external resources on Data Management-related issues and ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs).

Responsibilities

• Ensure the data collected meets the requirements of the study objective and company quality standards.
• Drive the development and implementation of strategic vision for the data management (DM) group.
• Provide functional oversight of CROs to prepare and ensure proper execution of data management plans and manage data management projects from beginning to end.
• Partner with Clinical Operations, biostatisticians, SAS programmers, and other staff to design and develop data collection instruments (e.g., eCRFs) to ensure required information is captured for statistical analysis.
• Oversee and, as needed, directly support coding review for adverse events, medical history, and concomitant medications; coordinate medical monitor review and approval of medical coding.
• Lead data management activities, clinical database cleaning in EDC, data reconciliation with external vendor data, SAE reconciliation, and lock activities.
• Lead development of data management plans, data review plans, supervise database development, and review and process clinical trial data to ensure completeness, accuracy, and consistency.
• Prepare and distribute or facilitate distribution of periodic reports of study status, including case report form (CRF) completion status, missing pages, query aging, and clean patient tracker (CPT).
• Participate in cross-functional team meetings and communicate project statuses/issues; provide ongoing feedback on data management workflows to increase efficiency and provide feedback to CRAs.
• Lead interactions with outside vendors (e.g., clinical laboratories) on collection, transmittal, and transfer of study-specific data.
• Develop and update SOPs and other documents associated with data collection, handling, and review processes (e.g., Working Instructions, Best Practices Documents) to meet regulatory compliance and operational needs.
• Facilitate and contribute to regulatory submissions and audit/inspection activities.
• Gather requirements related to existing clinical systems to identify opportunities to enhance, improve, and streamline processes and systems use.
• Lead the assessment and selection of Data Management vendors and systems for clinical data collection and analysis.
• Participate in clinical review and validation of statistical outputs used in the preparation of final reports.
• Mentor clinical team members by resolving problems and providing DM guidance.
• Manage multiple and varied tasks, prioritize workload with attention to detail.
• Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team.
• Drive the spirit of “ONE Team” across all functions by supporting a team approach to focus on patients and customers as top priorities.
• Lead the completion of data management activities to meet project timelines and communicate status to respective team members.
• Contribute to the development of outsourcing strategies and relationships with outsourcing partners; may play a role in the identification of quality DM partners, including coordinating the review and approval of the Master Services Agreement.
• May manage, coach, and mentor direct reports.
• Perform other tasks and assignments as needed and specified by management.

Requirements

• Bachelor’s degree in science or related field (such as healthcare) and a minimum of 10 years of relevant progressively responsible experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions.
• Proven track record of successful leadership of data management team(s).
• Previous leadership of vendor management experience using Interactive Web Response System (IWRS), Imaging, Patient Reported Outcome (ePRO/eCOA), and other database technologies.
• Highly detail-oriented while maintaining work efficiency; able to prioritize activities across various projects at different study stages.
• Knowledge of industry standards, such as ICH guidelines, CDASH, 21 CFR Part 11, and FDA guidelines.
• Understanding of the drug development process and data operations required for the reporting of clinical trial data (e.g., data review, study reports, regulatory submissions, safety updates).
• Strong verbal and written communication, decision-making, influencing, negotiation, and project management skills.
• Technical skills and experience using Medidata or relational databases (e.g., Oracle RDC, InForm, Veeva EDC) and data visualization tools (e.g., Spotfire, J-Review, Business Objects).
• Proficiency in the use of Microsoft Office Suite of tools (Word, Excel, etc.).
• Excellent time management, flexibility, and ability to coordinate workload and meet established deadlines.
• Ability to influence without direct authority.
• Demonstrated leadership ability and experience managing, coaching, and mentoring direct reports.
• Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization, and time management skills, including the ability to support and prioritize multiple projects.
• Knowledge of different regulatory standards and requirements, including but not limited to FDA, EMEA, and PMDA.

Preferred Qualifications

• Minimum five (5) years’ experience with Medidata RAVE (EDC, R2DS/RBS, Architect, Coder).
• Strong understanding and application of regulatory requirements and relevant data standards; CDISC knowledge and experience.
• Experience in PL/SQL, SAS, Java, C++ relational database design, and database programming skills.
• Understanding of Compliance and Regulations, such as ICH, GxP, Annex 11, GDPR, and GAMP.
• Understanding of the use of a risk-based approach for process efficiency and compliance.
• Clinical Data Interchange Standards Consortium (CDISC) experience.

Pay

Expected Base Salary Range: $200,700 - $252,600. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position, as well as review of internal equity. In addition to base salary, employees are eligible for short- and long-term incentives and may enroll in medical, dental, vision, and retirement savings plans.

Schedule

Up to 25% travel required.