Director of Clinical Data Management

Ovid Therapeutics; New York (NY); Hybrid; USD 210.000 - 245.000; Vollzeit

Benefits dieser Stelle

Hybrid work model

NYC office coordination

Zusammenfassung

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 individual will establish the strategy, standards, processes, and infrastructure needed to support global clinical trials across all phases of development.

The ideal candidate combines hands‑on clinical data management expertise with strategic leadership in a lean biotechnology

Qualifikationen

• Bachelor's or master's degree in a relevant scientific or technical discipline.
• 10+ years of clinical data management experience in biotech/pharma/CRO environments.
• Proven ability to lead data management CROs and external vendors.
• Experience in lean, outsourced development models is preferred.
• Strong knowledge of CDISC standards (CDASH/SDTM) and data integration.

Aufgaben

• Develop and lead the clinical data management strategy across programs and milestones.
• Set operating model, processes, standards, and best practices for outsourced CDM.
• Oversee CRO/vendor relationships, KPIs, and performance management.
• Translate development requirements into effective data management strategies.
• Identify opportunities to scale data management capabilities within the portfolio.
• Mitigate risks affecting data integrity, timelines, or regulatory compliance.
• Establish timelines and metrics for timely data delivery for interim analyses and reports.
• Stay current with emerging data management technologies and industry standards.

Kenntnisse

CDM leadership

Vendor oversight

Data standards

EDC systems

Data integration

Ausbildung

Bachelor's or Master's degree

Tools

EDC systems

Jobbeschreibung

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.

The Role On Our Team

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 individual 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 the 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 the strategic leadership needed to build and optimize the function in a lean biotechnology organization. They will be effective at managing multiple external partners, integrating diverse data sources, and collaborating across clinical operations, medical, biostatistics, and other functions. This opportunity is suited to an established Director or a strong Associate Director ready for broader leadership responsibility.

Key Responsibilities

Clinical Data Management Strategy & Leadership

• Develop and lead the clinical data management strategy across Ovid’s development programs, aligning study‑level 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 across multiple clinical data management CROs and external vendors, ensuring consistency, quality, efficiency, and accountability across studies.
• Translate clinical development requirements into effective data management strategies and solutions at the program and study levels.
• Identify opportunities to improve the structure, scalability, quality, and efficiency of data management activities as the portfolio evolves.
• 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 to ensure timely delivery of high‑quality clinical data in support of key study and program milestones, including interim analyses and database locks.
• Maintain awareness of emerging technologies, industry standards, and best practices, recommending improvements to Ovid's data management capabilities.

CRO & Vendor Selection and Oversight

• Lead the evaluation, selection, qualification, onboarding, and ongoing management of data management CROs and vendors.
• Assess vendor capabilities, personnel, processes, technology, and operating models to ensure the appropriate fit for Ovid's programs.
• Manage multiple CRO and vendor relationships, establishing clear expectations for deliverables, timelines, quality standards, documentation, and communication.
• Establish and monitor CRO performance metrics and key performance indicators (KPIs), including data entry timeliness, query aging, data cleaning progress, external data reconciliation, and database lock readiness.
• 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 in collaboration with Clinical Operations and Finance.
• Anticipate evolving resource and vendor needs as programs advance, bringing in additional partners and expertise as appropriate.
• Resolve or escalation issues at the study, program, or functional level, ensuring timely resolution and effective communication with internal stakeholders.

Clinical Data Systems, Database Design & Integration

• Oversee the development and implementation of standardized electronic case report forms(eCRFs), edit checks, data transfer specifications, and database validation activities to ensure consistency and quality across studies.
• Ensure appropriate oversight of external data sources, including central and specialty laboratories, electronic clinical outcome assessments (eCOA), and other third‑party clinical data systems, as applicable.
• Partner with Biostatistics and Statistical Programming to support CDISC data standards, including CDASH and SDTM, and ensure appropriate data traceability from collection through analysis and regulatory submission.
• Leverage technology, standardization, and process improvements to reduce manual effort, strengthen data quality, and increase operational efficiency.

Clinical Trial Execution & Data Quality

• Lead database lock planning and readiness activities in collaboration with Clinical Operations, Biostatistics, Clinical Science, and external CROs, ensuring that data cleaning, reconciliation, and required documentation are completed according to agreed timelines.
• Establish and oversee ongoing data review and cleaning processes, including identification and resolution of data discrepancies, missing data, protocol deviations, and critical data issues.
• Implement risk‑based data review strategies to prioritize critical data and identify potential data quality concerns early in study execution.
• 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).

Processes, Standards & Continuous Improvement

• 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, including ICH E6(R3) and 21 CFR Part 11, as applicable.
• Promote a culture of accountability, continuous improvement, and quality across internal teams and external partners.

Cross‑Functional Collaboration

• 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 in collaboration with relevant partners.
• Communicate data management strategy, progress, risks, and recommendations clearly and proactively to internal leadership and external vendors.
• Build and maintain productive relationships with external experts, industry peers, and thought leaders in clinical data management and related disciplines.

Qualifications & Experience

• 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, with the ability to identify risks and develop practical solutions.
• 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.

Ovid operates in a hybrid‑work model. Candidates applying must be willing and able to be in the NYC office in coordination with their manager's expectations, as well as department and business needs.

The base salary range for this position is $210,000-$245,000.The actual salary offered within the range is dependent on a variety of factors including, but not limited to, relevant experience, qualifications, skills, level offered, and performance expectations.