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 provide expertise for non-Kite-sponsored collaborative efforts and Investigator Sponsored Research.

• Contribute to the development of Kite's CDM strategy and associated processes.

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

• Effectively communicate study-level decisions and their implications to broader study teams.

• Deliver functional expertise during study initiation and execution, including protocol design and operational model expectations.

• Define expectations, establish data management timelines, and supervise study status and tasks with CRO partners.

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

• Review and manage the eTMF to ensure completeness, accuracy, and readiness for inspections.

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

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

• Supervise clinical data to ensure completeness, accuracy, consistency, and proper structure across the program.

• Manage or oversee deliverables related to CDM.

• Represent CDM during both internal and Health Authority audits.

• Lead the development, review, and execution of CDM processes, policies, SOPs, and related documentation.

• Lead or take part in cross-functional CDM initiatives.

• Provide insights into the CDM organizational strategy and facilitate departmental changes.

• Drive continuous improvement efforts and implementation within Clinical Data Management.

• Prioritize and assign responsibilities for studies and initiatives.

• Take on increased responsibilities for clinical project volume, complexity, and direct reports.

• Manage data managers and data management associates, oversee CDM vendors, and ensure adherence to project timelines and data management documentation.

• Train and mentor staff within the CDM team.

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

• Potentially oversee and develop direct reports.

⛳️ Requirements

• High School diploma with 12 years of experience OR Bachelor's degree with 8 years of experience OR Master's degree with 6 years of experience OR PhD/PharmD.

• Proven experience leading clinical data management deliverables for regulatory submissions.

• Experience in managing NIS studies in an oversight role.

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

• Demonstrated ability to lead through influence and navigate complex, global organizational structures.

• Familiarity with industry standard guidelines, including CDISC, CDASH, SDTM, or ADaM.

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

• Experience interpreting regulations from Health Authorities and GCP/ICH guidelines.

• Comprehensive knowledge of the pharmaceutical development process.

• Proficient in web-based Electronic Data Capture and clinical data management systems.

• Experience with industry-standard thesauri/dictionaries like MedDRA and WHODD.

• Solid project management skills.

• Exceptional verbal and written communication abilities.

• Experience in training and mentoring within Clinical Data Management.

• Capable of communicating and escalating project-level issues effectively.

• Adaptable to changing priorities, detail-oriented, able to work under pressure, and willing to tackle new tasks.

• Skilled in prioritizing and delegating responsibilities effectively.

🏝️ 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.

• Comprehensive benefits package.