Associate Director, Clinical Data Management

Role Summary

The Associate Director, Clinical Data Management is responsible for providing leadership and oversight of data management activities to ensure accuracy and consistency of clinical databases for subsequent analysis and reporting. 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. This position will assist in defining Sponsor processes and procedures for maintaining clinical data and the associated QA/QC Documentation.

She/He may have supervisory responsibilities for both internal staff and external consultants. They may also manage direct reports and work cross-functionally with various internal departments and external resources on Data Management related issues. The Associate Director, Clinical Data Management, supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Responsibilities

• Ensure the data collected meets the requirements of the study objective and company quality standards.
• Assist in the development and implementation of strategic vision for data management (DM) group.
• Collaborate with CROs to prepare and ensure proper execution of data management plans and manage data management projects from beginning to end.
• Work closely 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 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.
• 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 ‚ÄúONE Team‚Äù 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.

Qualifications

• Minimum level of education and years of relevant work experience.
• Bachelor‚Äôs degree in science or related field (such as healthcare) and a minimum of 8 years of relevant progressively responsible experience in a pharmaceutical, biotech, CRO, or Regulatory Agency with an emphasis on building data collection and assimilation solutions.
• Special knowledge or skills needed and/or licenses or certificates required.
• Experience in second-line management and functional leadership.
• Previous leadership of vendor management experience using Interactive Web Response System (IWRS), Imaging, Patient Reported Outcome (PRO) 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 ‚Äòscalability‚Äô 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.
• Special knowledge or skills and/or licenses or certificates preferred.
• Minimum five (5) years‚Äô experience with Medidata RAVE(EDC, R2DS/RBS, Architect).
• Experience with Medidata RAVE.
• 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.
• Travel requirements: 5-15%.

Education

• Not specified beyond above qualifications.