Sr Manager, Clinical Data Management

Responsibilities

• Drive and execute the management of CDM deliverables within the Kite sponsored NIS program (including Post-Marketing Required (PMR) studies and Expanded Access Programs (EAP)), in coordination with internal and external cross-functional teams
• Provide support and expertise on non-Kite sponsored collaborative and Investigator Sponsored Research (ISR), where needed
• Contribute to defining the Kite CDM strategy and processes for these types of studies
• Build strong working relationships with Clinical Operations, Medical Affairs, and Translational Medicine to understand upcoming study requirements and provide effective study oversight
• Recognizing the effects of study-level decisions at the Program Level and proactively communicating to the wider study team
• Provide functional area expertise and guidance during study initiation and conduct, including during protocol design and input into operating model expectations
• Communicate efficiently with the CRO counterpart (as needed) to define expectations, set DM timelines and oversee the study status and activities
• Works collaboratively with Clinical and Statistical Programming, Clinical Operations, Medical Affairs, Translational Medicine, Biostatistics and other study team members to meet project deliverables and timelines
• Anticipate obstacles and difficulties of stakeholders and staff and acts upon them in order to meet team goals
• Review and manage the eTMF for completeness and accuracy, ensuring inspection readiness, as applicable
• Oversight of study documentation, ensuring timely completion and ongoing adherence to regulatory expectations, relating to data integrity and patient safety
• Serve as a primary point of contact for internal and external study team members
• Oversee the completeness, accuracy, and consistency of clinical data and data structure across the program on an ongoing basis
• Perform management of CDM deliverables as described or provides oversight and guidance to Data Manager leading CDM deliverables
• Lead CDM representative during internal audits as well as Health Authority audits
• Lead the development, review, and implementation of processes, policies, SOPs, and associated documents affecting CDM and cross-functional groups
• Lead and/or participate in CDM cross-functional initiatives
• Proactively provide input into CDM organizational strategy and implements departmental change
• Proactively provide input to continuous improvement activities within Clinical Data Management and leads the relevant support for implementation
• Flexible to changing priorities, detail-oriented, works well under pressure, and able to take on unfamiliar tasks
• Prioritize and effectively delegate study and initiative responsibilities
• Assume expanded scope of responsibility with respect to volume and complexity of clinical project work as well as direct report responsibility
• To be proficient in web-based Electronic Data Capture (such as Medidata Rave and other clinical data management systems)
• Experienced with industry wide thesauri/dictionaries such as MedDRA and WHODD
• Have excellent verbal and written communication skills, including the ability to clearly describe critical technical CDM aspects to non-CDM staff
• Experienced project management skills
• Training and mentoring of all roles in CDM
• Communication and escalation of project level issues including processes, timelines, resourcing, performance, etc.
• Potential for direct report responsibility including oversight and development

Basic Qualifications

High School degree and 12 years of experience OR Bachelor's Degree and Eight Years' Experience OR Masters' Degree and Six Years' Experience OR PhD / PharmD

Preferred Qualifications

• Experience as independent lead in managing clinical data management deliverables for regulatory filings
• Experience managing NIS studies in an oversight capacity
• At least 10 years of relevant industry experience with clinical trials and a successful track record of leading through influence, working across complex, global organizational matrices
• Experience in Industry Standards Guidelines (e.g., CDISC) in either the collection (CDASH), tabulation (SDTM), or analysis (ADaM) models
• Strong knowledge of industry-leading EDC tools (e.g., Medidata Rave, Veeva EDC, Medrio EDC, Oracle, TrialGrid, etc.) and well versed in industry trends and emerging technologies supporting data collection
• Experience interpreting Health Authority regulations and GCP/ICH guidelines with a strong compliance background
• Strong working knowledge of the overall pharmaceutical development process
• Influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team