Director, Clinical Data Management

Job Description Summary 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 proactively develops plans for utilizing EDC system processes and other clinical data applications, leads and contributes in defining sponsor processes and procedures for maintaining clinical data, and oversees QA/QC documentation. She/He may have supervisory responsibilities for internal staff and external consultants and may manage direct reports. The incumbent works cross‑functionally with various internal departments and external resources on data‑management issues and ensures adherence to regulatory requirements and the company SOPs. Essential Functions 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 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 as appropriate to design and develop data collection instruments (e.g., eCRF) 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 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 CRF completion status, missing pages, query aging, clean patient tracker, etc. Participate in cross‑functional team meetings, communicate with all departments regarding project status/issues, and 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 and may play a role in identifying 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. Knowledge, Skills, and Abilities Required Minimum level of education and years of relevant work experience. Bachelor’s degree in science or related field 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) and vendor management experience using IWRS, imaging, 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 drug development process and data operations required for 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 Microsoft Office Suite (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 within a fast‑paced, matrixed, team environment with internal and external team members. Analytical thinker with excellent problem‑solving skills and 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 regulatory standards and requirements, including but not limited to FDA, EMEA, PMDA. Minimum five (5) years’s 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 risk‑based approach for process efficiency and compliance. Clinical Data Interchange Standards Consortium (CDISC) experience. Travel requirements: 25 % 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. In addition to base salary, employees are also eligible for short- and long-term incentives. Eligible employees may enroll in medical, dental, vision, and retirement savings plans. EEO Statement PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, veteran status, or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination. #J-18808-Ljbffr PTC Therapeutics, Inc.