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About the Role
Ovid Therapeutics is seeking a Director of Clinical Data Management to lead and evolve the clinical data management function across its development portfolio. This individual will establish the strategy, standards, processes, and infrastructure needed to support global clinical trials across all phases of development, overseeing data management CROs and vendors to ensure timely delivery of high-quality clinical trial data.
Responsibilities
- Develop and lead the clinical data management strategy across Ovid’s development programs.
- Establish and evolve the operating model, processes, standards, and best practices for a fully outsourced clinical data management function.
- Provide strategic oversight across multiple clinical data management CROs and external vendors.
- Translate clinical development requirements into effective data management strategies and solutions.
- Identify opportunities to improve the structure, scalability, quality, and efficiency of data management activities.
- Proactively identify, assess, and mitigate risks that could affect data integrity, study timelines, regulatory compliance, or clinical development milestones.
- Establish and maintain data management strategies, timelines, and performance metrics.
- Maintain awareness of emerging technologies, industry standards, and best practices.
- Lead the evaluation, selection, qualification, onboarding, and ongoing management of data management CROs and vendors.
- Assess vendor capabilities, personnel, processes, technology, and operating models.
- Manage multiple CRO and vendor relationships, establishing clear expectations.
- Establish and monitor CRO performance metrics and key performance indicators (KPIs).
- Hold CROs and external vendors accountable for agreed-upon deliverables, timelines, quality standards, and corrective action plans.
- Oversee data management vendor budgets, resource utilization, scope changes, and change orders.
- Anticipate evolving resource and vendor needs as programs advance.
- Resolve or escalate issues at the study, program, or functional level.
- Oversee the development and implementation of standardized electronic case report forms (eCRFs), edit checks, data transfer specifications, and database validation activities.
- Ensure appropriate oversight of external data sources, including central and specialty laboratories, electronic clinical outcome assessments (eCOA), and other third-party clinical data systems.
- Partner with Biostatistics and Statistical Programming to support CDISC data standards, including CDASH and SDTM.
- Leverage technology, standardization, and process improvements to reduce manual effort, strengthen data quality, and increase operational efficiency.
- Lead database lock planning and readiness activities.
- Establish and oversee ongoing data review and cleaning processes.
- Implement risk-based data review strategies.
- Ensure appropriate oversight of serious adverse event (SAE) reconciliation, medical coding, external data reconciliation, and other key data cleaning activities.
- Ensure data are appropriately reviewed and available to support Data Safety Monitoring Board (DSMB) reviews, Development Safety Update Reports (DSURs), interim analyses, tables, listings, and figures (TLFs), and final clinical study reports (CSRs).
- Lead the development, implementation, and ongoing maintenance of 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 functional areas to evaluate, recommend, and implement process and technology improvements.
- Ensure clinical data management activities, documentation, audit trails, and vendor oversight practices support regulatory inspections and compliance with applicable GCP requirements.
- Promote a culture of 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 clinical data are complete, consistent, traceable, and ready for analysis and reporting.
- Anticipate logistical and operational challenges associated with acquiring and integrating data from multiple sources and develop solutions.
- Communicate data management strategy, progress, risks, and recommendations clearly and proactively.
- Build and maintain productive relationships with external experts, industry peers, and thought leaders.
Requirements
- Bachelor's or master's degree in a relevant scientific, technical, or related discipline.
- 10+ 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 within a lean organization operating through 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 foundation in hands-on clinical data management, with the 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 manage complex, cross-functional activities and competing priorities independently, with minimal day-to-day supervision.
- Strong analytical, problem-solving, organizational, and decision-making skills.
- Excellent written and verbal communication skills, with 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.
Skills
- Clinical Data Management
- Vendor Oversight
- Functional Leadership
- EDC Systems
- Clinical Database Design
- Data Standards
- Metadata Management
- Data Transfer
- Data Integration
- Process Development
- SOP Development
- Risk Mitigation
- Stakeholder Management
- Negotiation
- Problem-Solving
- CDISC Data Standards (CDASH, SDTM)
Location
- New York, NY
Work Type
- Hybrid
Experience Level
- Director
- Associate Director
Education Level
- Bachelor's Degree
- Master's Degree
Salary/Compensations
- $210,000-$245,000
About the Company
- Ovid Therapeutics Inc. is a New York-based biopharmaceutical company dedicated to developing small molecule medicines for brain conditions with significant unmet need.
- The Company is advancing a pipeline of novel, targeted small molecule candidates that modulate the intrinsic and extrinsic factors involved in neuronal hyperexcitability causative of multiple neurological and neuropsychiatric disorders.
- It is with curiosity, courage, and tenacity that, together, we work for meaningful change in the lives of patients and their families.
- With this sense of purpose and urgency we challenge the conventional and embrace the wisdom and thought that comes from diverse backgrounds and perspectives.
- Importantly, we understand the commitment we make to our patients, our broad community and to each other is based on the humanity that we share.