Clinical Data Director, Data Management - REMOTE South San Francisco, California

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

Seeking a highly experienced and strategic Director, Data Management to partner with the Senior Director, Data Management in leading data management functions across one or more clinical development programs. This role is instrumental in ensuring operational excellence, regulatory compliance, process improvement, and the timely delivery of high-quality clinical data to support corporate milestones and regulatory submissions. The Director will provide leadership, mentorship, and operational oversight while driving innovation and continuous improvement within the data management team. Thie position reports directly to the Senior Director, Data Management.

Job Description

• Collaborate closely with the Senior Director, Data Management to execute the clinical data strategy, implement best practices, and meet operational goals across assigned clinical programs.
• Provide strategic leadership and operational oversight for all data management activities from study start-up through database lock and regulatory submission.
• Anticipate departmental needs, identify process gaps, and proactively propose and implement scalable, efficient solutions.
• Lead the development, enhancement, and implementation of standard operating procedures (SOPs), work instructions (Wis), data review plans, and data transfer agreements.
• Ensure data management processes adhere to Good Clinical Practice (GCP), applicable regulatory requirements, company SOPs/Wis, and Clinical Data Interchange Standards Consortium (CDISC) standards.
• Oversee data quality and integrity across assigned clinical programs.
• Oversee performance and deliverables of external vendors, ensuring alignment with timelines, quality standards, and contractual obligations.
• Provide input into vendor selection and oversight activities, including Requests for Information (RFIs), Requests for Proposals (RFPs), and bid defenses.
• Develop and track key performance indicators (KPIs) for data management vendors and partners in collaboration with cross-functional teams.
• Lead hiring efforts and manage allocation of internal and external data management and clinical programming resources based on program needs and budget considerations.
• Provide mentorship, professional development, and performance feedback to team members; foster a culture of collaboration, accountability, and continuous improvement.
• Collaborate closely with Clinical Operations, Medical, Clinical Science, Biostatistics, Programming, Regulatory, Safety, and other stakeholders to ensure coordinated planning and execution of clinical data activities.
• Identify potential data-related risks and work with the Senior Director and DM Leadership Team to develop and implement mitigation strategies.

Requirements:

• Bachelor’s or Master’s degree in a relevant discipline, including life sciences, health services, computer sciences, or related fields.
• Minimum of 15 years of experience in clinical data management within the biotechnology or pharmaceutical industry.
• Deep understanding of clinical trial processes including protocol development, CRF design, database build, data cleaning, and data review.
• Demonstrated expertise in global regulatory requirements (FDA, ICH, GCP) and CDISC standards.
• Proven experience leading data management teams and managing global CROs and external data vendors.
• Excellent ability to manage, motivate, develop, and empower staff.
• Excellent ability to manage competing priorities in a changing environment.
• Excellent verbal and written communication and relationship-building skills.
• Outstanding organizational and project management skills.
• Technical proficiency in clinical data systems and platforms; experience with EDC systems and clinical data repositories.

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 $110-$115 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:

Epic 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.