Associate Director Clinical Data Management

Associate Director, Clinical Data Management

Summary:

Works cross functionally in accordance with OTX corporate goals to deliver high-quality data for analysis and submissions. Identifies potential issues and focuses on effective resolution/escalation. Manages CROs, interfaces with cross-functional teams and influences project-level decision making. Leads and/or contributes to departmental initiatives as directed.

Responsibilities:

• Contributes to the direction and strategy for planning, execution, collection, and handling of clinical data for assigned programs and/or studies

• Leads and/or contributes to departmental initiatives as needed to ensure OTX Data Management (DM) execution and CRO oversight are in compliance with guidelines and regulations

• May work with trial management teams and biostatistics to develop and review request for proposals (RFPs) for applicable vendors

• Participates in vendor identification, selection, and management activities in collaboration with applicable teams

• Executes data vendor oversight activities including consistency, quality, and timeliness of all deliverables in compliance with GCP, SOP and regulatory requirements.

• Provides DM status updates including cycle times, productivity metrics, risks, and mitigations

• Implements documentation and archival standards including DM systems, databases, and specifications

• Identifies potential risks/challenges and implements solutions including proactive prevention strategies with appropriate communication to DM leadership and both internal and external stakeholders

• Contributes to DM related inspection readiness activities including documentation for database builds, data review, and data extract for all points of data and associated data flow diagrams

• Performs other duties as assigned

Qualification Requirements:

• Bachelor's degree in health profession, science, or related field. Advanced degree preferred

• Eight (8) plus years of experience in the pharmaceutical industry with a minimum of six (6) years of experience in data management

• Proven experience with Phase III study management and submission

• Strong knowledge of SOPs, GCP standards, CDASH/CDISC standards, and clinical data management systems

• Experience with EDC systems: Veeva, IBM Clinical (Zelta/Merative) and Medrio; WHO Drug/MedDRA Coding and clinical database programming experience a plus

• Computer literacy, proficiency in MS Office suite, TEAMS, SharePoint, etc.

• Excellent written and oral communication skills

• Demonstrated ability to collaborate with cross-functional teams

• Excellent organizational skills and attention to detail

• Ability to prioritize and multitask

• Ability to apply knowledge of GCP and applicable regulations and guidance

• Some travel required for occasional vendor training and educational seminars. Ability to travel approximately 10%.