Jobs at Nektar Therapeutics

The Associate Director, Clinical Data Management provides strategic and operational leadership for clinical trial data management activities from study start-up through database lock. This role oversees CRF/eCRF design, database development, validation programming, discrepancy management, and database release while managing CROs and external service providers throughout the data management lifecycle.

Working cross-functionally with Clinical Operations, Biostatistics, and Regulatory Affairs, the Associate Director ensures the accurate, timely, and compliant collection of clinical trial data that supports the development of innovative therapies addressing unmet medical needs.

Clinical Data Management Leadership

• Lead the planning, execution, and oversight of clinical trial data management activities across multiple studies.
• Direct the development, implementation, and maintenance of study-specific Data Management Plans (DMPs).
• Ensure clinical database development, validation, data review, discrepancy management, and database release activities are completed on time and to quality standards.
• Apply sound judgment and expertise to solve complex data management challenges and drive study objectives.

Study Design and Data Collection

• Collaborate with Clinical, Biostatistics, and Regulatory teams to develop key study documents, including:
• Clinical Protocols
• Case Report Forms (CRFs/eCRFs)
• Statistical Analysis Plans (SAPs)
• Oversee the creation and maintenance of:
• CRF Completion Guidelines
• Annotated CRFs
• Data Handling Plans
• Data Entry Review Guidelines
• Edit Check Specifications
• Data Transfer Specifications
• Database Audit Plans

CRO and Vendor Management

• Provide oversight and direction to contract data management organizations and service providers.
• Monitor project timelines, budgets, and deliverables to ensure successful study execution.
• Conduct CRO data management inspections and audits as required.
• Maintain strong partnerships with vendors to ensure high-quality data management support.

Data Review and Quality Oversight

• Lead ongoing data review activities throughout study conduct.
• Ensure timely identification, investigation, and resolution of data discrepancies and errors.
• Oversee site query management and documentation of permanent data issues.
• Communicate data quality issues and risks to study teams.
• Deliver high-quality, locked databases ready for statistical analysis.

Process Improvement and Innovation

• Lead and support new data management initiatives, including implementation of electronic data capture (EDC) capabilities.
• Contribute to the development and enhancement of departmental policies, standards, and best practices.
• Identify opportunities for process improvement and operational efficiencies.

Team Development

• Mentor and support junior clinical data management staff.
• Foster a collaborative, high-performance team environment.
• Share knowledge and best practices across the organization.

Required Skills

• Strong problem-solving and analytical capabilities.
• Excellent organizational and project management skills.
• Effective written and verbal communication skills.
• Strong interpersonal and cross-functional collaboration abilities.
• Advanced knowledge of clinical data management processes, systems, and methodologies.
• Thorough understanding of ICH and Good Clinical Practice (GCP) requirements.
• Proficiency with Microsoft Project, Word, and PowerPoint.

Preferred Qualifications

• Solid understanding of clinical drug development processes.
• Experience developing data management procedures, processes, and training programs.
• Previous people management experience.
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Minimum Professional Experience

• Minimum 10 years of pharmaceutical development experience.
• At least 4 years of experience managing CROs.
• Extensive experience in clinical study design and execution.
• 8 years of management experience preferred.

Education Requirements

• Bachelor's degree in Clinical Sciences, Biological Sciences, Mathematical Sciences, Nursing, or a related field required.
• Advanced degree preferred.
• Equivalent combination of education and relevant experience may be considered.