Remote Director Clinical Data Management - Oncology

Director, Clinical Data Management - Oncology

Location: Remote (US) or Hybrid in NYC | must be located on East Coast
Industry: Oncology Biopharmaceutical Company (Commercial-Stage)

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

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.

Position Overview

The Director, Clinical Data Management will be responsible for the strategic oversight, execution, and continuous improvement of clinical data management activities across the development portfolio. This role will lead internal and external teams, drive data quality initiatives, oversee vendor relationships, and ensure operational excellence from study startup through regulatory submission. The successful candidate will serve as a key cross-functional partner across Clinical Operations, Biostatistics, Regulatory Affairs, Medical Writing, and Clinical Development.

Key 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.