Remote Director Clinical Data Management - Oncology

Location: Remote (US) or Hybrid in NYC | must be located on East Coast

About the Opportunity

We're partnered with a commercial-stage biopharmaceutical company dedicated to advancing innovative therapies for patients with serious cancers. With a growing clinical pipeline and a strong commitment to scientific excellence, the organization is seeking a strategic and operational leader to join its Clinical Development organization as Director, Clinical Data Management - Oncology. This individual will provide leadership across multiple clinical programs and play a critical role in ensuring the delivery of high-quality, inspection-ready clinical data.

Responsibilities

Leadership & Strategy

• Collaborate with senior leadership to define and execute Clinical Data Management (CDM) strategy aligned with corporate objectives.
• Contribute to long-range planning, departmental growth initiatives, and operational excellence programs.
• Lead and mentor internal CDM staff while providing oversight of external partners and CROs.
• Foster a culture of accountability, innovation, and continuous process improvement.

Clinical Data Management Oversight

• Oversee all CDM activities across multiple clinical studies and development programs.
• Direct the design, testing, validation, implementation, and maintenance of clinical databases and EDC systems.
• Ensure consistent application of CDM standards, SOPs, and industry best practices.
• Establish and oversee processes related to database build, edit checks, discrepancy management, data review, and database lock activities.
• Drive development and execution of data quality strategies and risk-based data review plans.

Cross-Functional Collaboration

• Partner with Clinical Operations, Biostatistics, Medical Monitoring, Regulatory Affairs, and Statistical Programming teams to support study execution and data delivery timelines.
• Provide proactive input into protocol development, CRF design, and data collection strategies.
• Ensure consistency and standardization across studies while aligning with scientific and regulatory requirements.
• Participate in study teams and provide strategic guidance throughout the clinical trial lifecycle.

Regulatory & Submission Support

• Support regulatory submission readiness and data integration efforts.
• Contribute to clinical study reports, submission deliverables, and health authority inspections.
• Ensure compliance with GCP, ICH guidelines, and applicable regulatory requirements.
• Maintain inspection-ready documentation and processes.

Vendor Management

• Lead oversight of CROs and third-party vendors.
• Manage vendor performance against contractual deliverables, timelines, budgets, and quality metrics.
• Establish governance processes that ensure accountability, transparency, and high-quality execution.

Qualifications

Required

• Bachelor's degree in Life Sciences, Computer Science, Statistics, or related field.
• 12+ years of significant progressive experience in Clinical Data Management within the biotechnology, pharmaceutical, or CRO industry.
• Demonstrated leadership experience managing internal teams and external vendors.
• Strong knowledge of clinical trial processes, GCP, ICH guidelines, and data governance principles.
• Experience supporting regulatory submissions and health authority inspections.
• Hands-on experience with EDC platforms and clinical database technologies.
• Strong project management and stakeholder management skills.

Preferred

• Oncology clinical development experience.
• Experience with industry standards including CDISC, CDASH, and SDTM.
• Proficiency with EDC systems such as Medidata Rave.
• Experience supporting both early and late-stage clinical development programs.
• Track record driving operational improvements and implementing scalable CDM processes.

Ideal Profile

The ideal candidate is a strategic CDM leader who combines deep technical expertise with strong business acumen. They are comfortable operating in a fast-paced biotech environment, influencing cross-functional stakeholders, managing complex vendor relationships, and ensuring high-quality data delivery that supports critical development milestones and regulatory submissions.

Why This Opportunity?

• Visible leadership role within a growing oncology organization.
• Broad influence across clinical development programs.
• Opportunity to shape CDM strategy, processes, and infrastructure.
• High-impact role supporting innovative therapies for patients with significant unmet medical needs.

Pay

$220,000-250,000 + bonus + additional benefits