Senior Manager, Clinical Data Management

职位描述

Senior Manager, Clinical Data Management (CDM) is a hands-on role working cross-functionally with internal and external partners to support our efforts in this fast-growing and important area of cell therapy. The role will report to the Associate Director, CDM or higher.

You will be responsible for guiding and overseeing all aspects of clinical data management for Kite’s clinical development programs with guidance from the Associate Director, CDM or Director, CDM. You will be the lead representative working with cross-functional teams such as Clinical Operations, Safety, Biometrics, Clinical Development, and Regulatory as necessary.

You will be responsible for managing data managers and data management associates, overseeing CDM vendors (external and/or CRO), creating and maintaining project timelines and data management documents, working with Clinical Programming to create clinical databases and data quality reports, supporting clinical data collection and data review activities, and study closure.

Job Responsibilities

• Facilitate and implement the management of CDM deliverables in coordination with internal and external cross-functional teams
• Recognizing the effects of a study level decision on the Program Level and pro-actively communicating and sharing them
• Independently lead by providing CDM expertise for data coordination, collection, and cleaning to efficiently ensure high quality data
• Perform the implementation of end-to-end Data Management activities (e.g., eCRF development, Data Review, study lock) for multiple studies across therapeutic areas and/or indications
• Develop and manage data management timelines to ensure study goals and activities are met
• Oversee project level coordination and day-to-day support of External Data Management tasks (development of Data Transfer Plans, coordination of file transfers to meet study deliverables etc.)
• 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
• Independently oversees of the development and finalization of CDM documents to be filed in the eTMF
• Serve as a primary point of contact for internal and external study team members
• Ensure completeness, accuracy, and consistency of clinical data and data structure across all projects on an ongoing basis
• Responsible for data review, query management, and metric report delivery to study teams
• Coordinate study timelines and database snapshots for analysis and safety review meetings
• 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
• Works collaboratively with Clinical and Statistical Programming, Clinical Operations, Biostatistics and other study team members to meet project deliverables and timelines
• 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.
• Direct report responsibility including oversight and development

Basic Qualifications

Doctorate

OR

Master’s and 6+ years of Data Management experience

OR

Bachelor’s and 8+ years of Data Management experience

OR

High School Diploma/GED and 12+ years of Data Management experience

Preferred Qualifications

• Experience as independent lead in managing clinical data management deliverables for regulatory filings
• 10+ years of relevant industry experience with clinical trials and a successful track record of guiding 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
• Thorough 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 an excellent compliance background
• Deep working knowledge of the overall pharmaceutical development process
• Influential leadership and communication capabilities with a demonstrated ability to engage, manage, develop and inspire a geographically diverse team

The work you do at Kite will help change how cancer is treated and ensure patients and their families have more time together. Ready to create more tomorrows with us? Hit apply.