Director, Clinical Data Management

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

• 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.

• A 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 the ICH guidelines, CDASH, 21 CFR Part 11, and FDA guidelines. 

• Understanding of drug development process and data operations required for the reporting of clinical trial data (e.g., data review, study reports, regulatory submissions, safety updates, etc.).

• 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.).

• Learning agility and ‘scalability’ to take on increasing responsibility Excellent time management, flexibility, 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, as required, 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.

• 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 preferred.

• Understanding of Compliance and Regulations, such as ICH, GxP, Annex 11, GDPR and GAMP.

• Understanding of the use of risk-based approach for process efficiency and compliance.

• Clinical Data Interchange Standards Consortium (CDISC) experience.

Primary duties/responsibilities

• Ensure the data collected meets the requirements of the study objective and company quality standards.

•  Drives the development and implementation of strategic vision for 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.

• Partners with Clinical Operations group, biostatisticians, SAS programmers and other staff as appropriate to design and develop data collection instruments (e.g., eCRF's) to ensure the required information is captured for statistical analysis.

• Oversee and as needed, directly support coding review for adverse events, medical history and concomitant medications and 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 reviewing and processing of clinical trial data to ensure completeness, accuracy, and consistency of clinical trials data.

• Prepare and distribute or facilitate distribution of periodic reports of study status including, case report form (CRF) completion status, missing pages, query aging, clean patient tracker (CPT), etc.

• Participate in cross functional team meetings, as requested, and communicate with all departments regarding 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 SOP's and other documents associated with the data collection, handling, and review processes, e.g., Working Instructions (WI), Best Practices Documents (BPD)to meet regulatory compliance and operational needs.

• Facilitates and contributes to regulatory submissions and audit/inspection activities.

• Gathers requirements related to existing clinical systems to identify opportunities to enhance, improve and streamline processes and systems use.

• Leads 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 our patients and customers as our 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 partner and may play a role in identification of quality DM partners including coordinating the review and approval of the Master Services Agreement.

• May manage, coach, and mentor direct reports.

• Performs other tasks and assignments as needed and specified by management.