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.

Requirements

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
Experience as independent lead in managing clinical data management deliverables for regulatory filings
At least 6 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.)

Benefits

company-sponsored medical, dental, vision, and life insurance plans*
discretionary annual bonus
discretionary stock-based long-term incentives (eligibility may vary based on role)
paid time off

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

data managementeCRF developmentdata reviewquery managementmetric report deliverydata coordinationdata cleaningclinical data managementCDISCregulatory filings

Soft Skills

leadershipcommunicationcollaborationproblem-solvingflexibilitydetail-orientedprioritizationdelegationmentoringcontinuous improvement