Director of Clinical Data Management

Ovid Therapeutics•New York, NY

1d•$210,000 - $245,000•Hybrid

About The Position

Ovid Therapeutics is seeking a Director of Clinical Data Management to lead and evolve the clinical data management function across its development portfolio. Reporting to the Vice President of Clinical Operations, this person will establish the strategy, standards, processes, and infrastructure needed to support global clinical trials across all phases of development. In Ovid’s fully outsourced model, the Director will oversee data management CROs and vendors and ensure timely delivery of consistent, high-quality clinical trial data. The role is accountable for data management from study start-up through database lock and final clinical study reporting, while improving efficiency and scaling capabilities as the pipeline advances. The ideal candidate combines hands-on clinical data management expertise with strategic leadership to build and optimize the function in a lean biotechnology organization. They will manage multiple external partners, integrate diverse data sources, and collaborate across clinical operations, medical, biostatistics, and other functions. The opportunity is suited to an established Director or a strong Associate Director ready for broader leadership responsibility. Ovid operates in a hybrid-work model. Candidates must be willing and able to work in the NYC office in coordination with their manager’s expectations and department and business needs.

Requirements

Bachelor’s or master’s degree in a relevant scientific, technical, or related discipline.
10 or more years of clinical data management experience in biotechnology, pharmaceutical, or CRO environments, including study execution, vendor oversight, and functional leadership.
Demonstrated experience in a small or emerging biotechnology company, preferably in a lean organization using a fully outsourced clinical development model.
Proven ability to select, onboard, oversee, and manage the performance of multiple data management CROs and external vendors.
Strong hands-on clinical data management foundation and ability to apply practical technical experience to functional strategy and decision-making.
Experience supporting global clinical trials across Phase 1, Phase 2, and Phase 3 development.
Strong knowledge of EDC systems, clinical database design, data standards, metadata management, and data transfer and integration processes.
Demonstrated experience managing clinical data from CROs, specialty laboratories, and other third-party providers.
Experience developing and implementing data management processes, SOPs, work instructions, and quality standards.
Ability to independently manage complex cross-functional activities and competing priorities with minimal day-to-day supervision.
Strong analytical, problem-solving, organizational, and decision-making skills, including the ability to identify risks and develop practical solutions.
Excellent written and verbal communication skills and highly developed interpersonal, negotiation, and stakeholder-management capabilities.
Ability to work effectively across diverse teams and external partners, manage group dynamics, resolve conflicts, and adapt to changing organizational and program needs.
Demonstrated initiative, flexibility, sound judgment, and a continuous-improvement mindset.
Willingness and ability to work in the NYC office in coordination with manager expectations and department and business needs.

Responsibilities

Develop and lead clinical data management strategy across development programs, aligning study execution with program milestones and development priorities.
Establish and evolve the operating model, processes, standards, and best practices for a fully outsourced clinical data management function.
Provide strategic oversight of multiple clinical data management CROs and external vendors, ensuring consistency, quality, efficiency, and accountability.
Translate clinical development requirements into data management strategies and solutions at program and study levels.
Identify opportunities to improve the structure, scalability, quality, and efficiency of data management activities as the portfolio evolves.
Identify, assess, and mitigate risks affecting data integrity, study timelines, regulatory compliance, or clinical development milestones.
Establish and maintain data management strategies, timelines, and performance metrics for delivery of high-quality clinical data, including for interim analyses and database locks.
Monitor emerging technologies, industry standards, and best practices, and recommend improvements to Ovid’s data management capabilities.
Lead the evaluation, selection, qualification, onboarding, and ongoing management of data management CROs and vendors.
Assess vendor capabilities, personnel, processes, technology, and operating models for suitability to Ovid’s programs.
Set expectations for CROs and vendors regarding deliverables, timelines, quality standards, documentation, and communication.
Establish and monitor CRO performance metrics and KPIs, including data-entry timeliness, query aging, data-cleaning progress, external-data reconciliation, and database-lock readiness.
Hold CROs and vendors accountable for deliverables, timelines, quality standards, and corrective action plans.
Oversee vendor budgets, resource utilization, scope changes, and change orders in collaboration with Clinical Operations and Finance.
Anticipate evolving resource and vendor needs as programs advance, and bring in additional partners and expertise as appropriate.
Resolve or escalate issues at the study, program, or functional level and ensure timely resolution and stakeholder communication.
Oversee development and implementation of standardized eCRFs, edit checks, data-transfer specifications, and database validation activities.
Oversee external data sources, including central and specialty laboratories, eCOA, and other third-party clinical data systems, as applicable.
Partner with Biostatistics and Statistical Programming on CDISC data standards, including CDASH and SDTM, and ensure data traceability from collection through analysis and regulatory submission.
Use technology, standardization, and process improvements to reduce manual effort, strengthen data quality, and increase operational efficiency.
Lead database-lock planning and readiness with Clinical Operations, Biostatistics, Clinical Science, and external CROs, ensuring cleaning, reconciliation, and documentation are completed on schedule.
Establish and oversee ongoing data-review and cleaning processes, including resolution of discrepancies, missing data, protocol deviations, and critical data issues.
Implement risk-based data-review strategies to prioritize critical data and identify quality concerns early.
Oversee SAE reconciliation, medical coding, external-data reconciliation, and other key data-cleaning activities.
Ensure data are reviewed and available to support DSMB reviews, DSURs, interim analyses, TLFs, and final CSRs.
Develop, implement, and maintain clinical data management SOPs, work instructions, guidelines, and standardized processes.
Ensure consistent application of data management standards and practices across studies, programs, and external partners.
Collaborate across functions to evaluate, recommend, and implement process and technology improvements.
Ensure data management activities, documentation, audit trails, and vendor oversight support regulatory inspections and applicable GCP requirements, including ICH E6(R3) and 21 CFR Part 11, as applicable.
Promote accountability, continuous improvement, and quality across internal teams and external partners.
Partner with clinical operations, medical, clinical science, biostatistics, and other internal and external stakeholders.
Work with clinical and medical teams to translate protocol requirements and scientific objectives into effective data collection and management strategies.
Coordinate with biostatistics and other stakeholders to ensure data are complete, consistent, traceable, and ready for analysis and reporting.
Anticipate operational challenges in acquiring and integrating data from multiple sources and develop solutions with relevant partners.
Communicate data management strategy, progress, risks, and recommendations proactively to leadership and external vendors.
Build and maintain productive relationships with external experts, industry peers, and thought leaders in clinical data management and related disciplines.