Associate Director, Data Management

Orbis Clinical is seeking a remote-based Associate Director, Data Management for 12 months.

Position Summary:

Seeking a talented and highly motivated Associate Director, Data Management to provide strategic and operational leadership on one or more clinical development programs. This individual will oversee clinical data management planning, execution, quality and delivery across multiple programs, supporting clinical milestones and regulatory submissions. 

The Associate Director will guide Lead Data Managers, CROs and service providers while retaining the technical depth to address critical study challenges. The role will strengthen cross-functional collaboration, proactive risk management, data standards and scalable operating practices.

What you’ll do:

• Lead Data Management strategy and execution across multiple clinical development programs.
• Provide direction and accountability to Lead Data Managers and study teams for quality, timelines and deliverables.
• Develop and oversee study-level DM plans, milestones, priorities, resources and risk mitigation strategies.
• Lead readiness for interim analyses, database freezes, database locks, regulatory submissions and other critical milestones.
• Escalate complex risks and decisions with clear recommendations; provide hands-on support when business-critical needs arise.
• Oversee CROs, functional service providers and DM vendors, including scope, performance, quality and delivery.
• Establish performance metrics, governance, escalation pathways and corrective actions.
• Oversee external data transfer and reconciliation processes for IRT, laboratories, imaging, ECG and other sources.
• Support vendor selection, scope development and resource planning, as applicable.
• Represent Data Management in study governance and cross-functional planning with Clinical Operations, Clinical Science, Biostatistics, Statistical Programming, Safety and Clinical Pharmacology.
• Lead resolution of complex data and operational issues and communicate decisions, risks and mitigation plans to stakeholders.
• Provide DM input into clinical protocols and proactively identify EDC database design risks, assess their impact on data collection, quality, and downstream analyses and recommend practical solutions to ensure alignment with study objectives and operational requirements.
• Oversee EDC design, database builds, amendments, testing, UAT, deployment and maintenance.
• Ensure robust data review, query management, coding, external data reconciliation and data cleaning.
• Oversee study documentation, including Data Management Plans, Data Review Plans, and data transfer specifications.
• Use metrics, listings and dashboards to monitor quality, progress and risks.
• Ensure adherence to applicable regulations, ICH/GCP, internal procedures and data standards; support audits, inspections and CAPA activities.
• Lead improvements to DM SOPs, work instructions, templates, governance and operational workflows.
• Promote CDISC/CDASH-aligned CRFs, controlled terminology, edit check and reusable design components.
• Identify opportunities for automation, reporting, dashboards and scalable technology solutions.
• Mentor DM colleagues and support workload planning, capability development and resource prioritization.

Requirements:

• Bachelor’s degree in life sciences or a related field and approximately 8–10 years of progressive Clinical Data Management experience, or an equivalent combination of education and relevant experience.
• Experience leading multiple clinical programs overseeing Lead Data Managers, CROs or functional service providers.
• Oncology experience strongly preferred; early-phase, late-phase or adaptive trial experience desirable.
• Experience with Veeva CDMS and/or Medidata Rave, EDC design, UAT, reconciliation and database lock.
• Knowledge of CDISC/CDASH, MedDRA, WHODrug and clinical data standardization.
• Experience improving processes, metrics and vendor oversight frameworkds; reporting, visualization or SAS-based review experience is a plus.
• Experience mentoring colleagues; formal people management experience is desirable.
• Comprehensive knowledge of Clinical Data Management, CDISC standards, FDA regulations, and ICH/GCP requirements and data integrity principles.
• Ability to influence stakeholders, exercise sound judgement and drive accountability without direct authority.
• Strong planning, prioritization, risk management and complex problem-solving skills.
• Excellent communication and collaboration skills, including communication with senior leadership.

Compensation Details:

• Orbis Clinical provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location. 
• The Pay Range for this position is $95-$105 per hour, can vary depending on employment status.
• Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k). .

EEO and Reasonable Accommodation Statement:

Stone Harbor Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.