Manager, Clinical Data Management

We’re here for one reason and one reason only – to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet.

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Job Description

The Manager, Clinical Data Management (CDM) will be 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 Senior Manager, CDM or higher.  
 

Responsibilities (include but are not limited to):

• Lead the management of CDM deliverables in coordination with internal and external cross-functional teams

• Lead by providing CDM expertise for data coordination, collection, and cleaning to efficiently ensure high quality data

• Perform the execution 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 External Data Management activities by providing project level 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 or escalates accordingly in order to meet team goals

• Manage the development and finalization of CDM documents to be filed in the eTMF

• Review and manage the eTMF for completeness and accuracy, ensuring inspection readiness 

• Serve as a primary point of contact for internal and external study team members in relation to all Data Management activities

• 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

• Participate in and/or represent CDM during internal audits as well as Health Authority audits and inspections

• Participate in the development, review, and implementation of processes, policies, SOPs, and associated documents affecting CDM

• Participate in CDM and cross-functional initiatives

• Proactively provides input to continuous improvement activities within Clinical Data Management and provides the relevant support for implementation

• Flexible to changing priorities, detail-oriented, works well under pressure, and able to take on unfamiliar tasks

• Demonstrates an ability to prioritize and delegate effectively

• Demonstrates ability to assume expanded scope of responsibility with respect to volume and complexity of clinical project work

• Works collaboratively with Clinical and Statistical Programming, Clinical Operations, Biostatistics, and others study team members to meet project deliverables and timelines

• Demonstrates proficiency with 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

• Demonstrates excellent verbal and written communication skills, including the ability to clearly describe critical technical CDM aspects to non-CDM staff

• Training and mentoring of junior CDM staff

• Communication and escalation of project level issues including processes, timelines, resourcing, performance, etc.

• May have direct report responsibilities including oversight and development

Basic Qualifications

• MS/MA in life sciences or related discipline and 4+ years of experience in Data Management OR

• BS/BA in life science or related discipline and 6+ years of experience in Data Management OR

• High School degree and 10+ years of experience in Data Management

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