Senior Manager, Clinical Data Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead and manage all facets of clinical data management for Kite-sponsored Non-Interventional Studies, which include Post-Marketing Required studies and Expanded Access Programs.

• Offer support and expertise for collaborative initiatives that are not sponsored by Kite and for Investigator Sponsored Research.

• Contribute to the development of Kite's Clinical Data Management strategy and processes.

• Establish productive working relationships with Clinical Operations, Medical Affairs, and Translational Medicine.

• Provide oversight during study initiation and execution, which encompasses protocol design and operational model expectations.

• Define expectations, establish data management timelines, and monitor study progress and activities alongside CRO counterparts.

• Collaborate with Clinical and Statistical Programming, Clinical Operations, Medical Affairs, Translational Medicine, Biostatistics, and other team members involved in the study.

• Review and manage the electronic Trial Master File (eTMF) for completeness, accuracy, and readiness for inspection.

• Oversee study documentation and ensure compliance with regulatory standards concerning data integrity and patient safety.

• Serve as the primary liaison for both internal and external study team members.

• Ensure the completeness, accuracy, and consistency of clinical data and associated data structures.

• Manage or provide oversight and guidance on Clinical Data Management deliverables.

• Represent Clinical Data Management during both internal and Health Authority audits.

• Direct the development, review, and implementation of Clinical Data Management processes, policies, SOPs, and related documentation.

• Lead or participate in cross-functional Clinical Data Management initiatives.

• Contribute to organizational strategy and facilitate departmental changes.

• Spearhead continuous improvement activities and provide implementation support.

• Prioritize and delegate responsibilities related to studies and initiatives.

• Assume greater responsibility for complex clinical projects and direct reports.

• Communicate and escalate project-related issues concerning processes, timelines, resources, and performance.

• Train and mentor individuals in Clinical Data Management roles.

• Foster inclusion, develop talent, and empower teams as a people leader.

⛳️ Requirements

• High School diploma with 12 years of experience, OR a Bachelor's Degree with eight years' experience, OR a Master's Degree with six years' experience, OR a PhD / PharmD.

• Proven experience as an independent lead managing clinical data management deliverables for regulatory submissions.

• Experience overseeing NIS studies.

• Minimum of 10 years of relevant industry experience in clinical trials.

• A successful track record of leading through influence and navigating complex, global organizational structures.

• Familiarity with Industry Standards Guidelines, including CDISC, CDASH, SDTM, or ADaM.

• Strong knowledge of leading EDC tools such as Medidata Rave, Veeva EDC, Medrio EDC, Oracle, or TrialGrid.

• Experience in interpreting Health Authority regulations and GCP/ICH guidelines.

• Comprehensive understanding of the overall pharmaceutical development process.

• Strong leadership and communication skills.

• Proficient in web-based Electronic Data Capture systems.

• Familiar with industry-standard thesauri/dictionaries such as MedDRA and WHODD.

• Excellent verbal and written communication abilities.

• Experienced in project management.

• Flexible, detail-oriented, capable of working under pressure, and willing to undertake unfamiliar tasks.

• Training and mentoring experience within Clinical Data Management.

• Potential for direct report responsibilities, including oversight and development.

🏝️ Benefits

• Discretionary annual bonus.

• Discretionary stock-based long-term incentives.

• Paid time off.

• Company-sponsored medical insurance.

• Company-sponsored dental insurance.

• Company-sponsored vision insurance.

• Company-sponsored life insurance.

• Equal employment opportunity and support for reasonable accommodation.