Associate Director – Clinical Data Management

Associate Director – Clinical Data Management

Requirements

• 10+ years of experience and a Bachelor’s degree, or 8+ years of experience and a post graduate degree.
• Proven experience in clinical data management gained from working at recognized clinical data management suppliers/vendors, reputable CRO(s) and/or a Sponsor environment working on multi-phase, multi-therapeutic (Oncology experience will be preferred) and diverse clinical trials from study initiation to completion and associated regulatory submission and inspection preparation.
• Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors.
• Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management.
• Strong knowledge and experience of EDC systems (Veeva CDMS preferred); demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection.
• Experience managing non-EDC data sourced from laboratories, eCOA and IRT.
• Strong project management; exhibits expertise in metrics analysis and reporting methodologies.
• Good understanding of coding (MedDRA, WHO drug dictionaries).
• Excellent oral and written communication skills, with all stakeholder levels.
• Deep knowledge of CDASH/CDISC (CDASH CRF Library implementation experience is preferred).
• Knowledge of submission requirements, [e.g., New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)].

Responsibilities

• Provides clinical data management leadership within the study team(s) to align on and drive data collection requirements for one or more complex clinical development projects.
• Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects.
• Responsible for end-to-end clinical data management activities and serves as a primary point of contact for internal/external study team members and stakeholders.
• Provides strong quality and project oversight over third party vendor(s) responsible for data management deliverables.
• Takes a leadership role to gather content and integration requirements for EDC and ensuring close collaboration/alignment with partners supporting other data collection systems (eCOA, External Data, RTSM, etc.). Enforces data standard conventions and ensures high quality expectations for all clinical data per defined processes & best industry practices.
• Authors, reviews/revises clinical data management related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization.
• Chairs Data Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality and completeness.
• Represents Data Management on cross-functional project teams & submission teams.
• Lead or support the Health Authority inspections and audits as relates to Data Management activities.
• Act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA), as required.
• Define, manage and govern clinical data standards in accordance with CDASH principles and best practices.
• Responsible for managing clinical data management staff, as assigned, including training, mentoring, goal setting, performance management and engagement.

Preferred Qualifications

• Oncology experience will be preferred.
• Veeva CDMS preferred;
• CDASH CRF Library implementation experience is preferred.