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Moderna Services, Inc. seeks a Sr. Manager, Clinical Data Management for its Cambridge, Massachusetts location.
Here’s What You’ll Do:
Lead data management activities for in-house and outsourced studies.
Responsible for vendor oversight activities across global development programs.
Represent data management function in clinical cross-functional meetings, ensuring aligned expectations between the Contract Research Organization (CRO) and Moderna for all data related deliverables, especially in support of key decision points and regulatory submissions.
Ensure established milestones and deliverables are met with the highest degree of quality.
Partner with appropriate stakeholders and CRO partners to mitigate and resolve risks.
Provide input to functional governance with Moderna strategic suppliers.
Partner with appropriate stakeholders to resolve issues escalated from the vendor and/or cross-functional teams.
Lead and manage clinical trial data collection set-up, data review, and database lock for studies where data management activities are conducted within Moderna.
Work with other functions to complete set up of Electronic Data Capture (EDC) and study data collection tools such as Inter-response time (IRT), ePRO and eCOA.
Lead the creation and maintenance of study cross functional data review plan components, including:
Lead data review, including query management, and activities required for interim and final database locks.
Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents.
Ensure achievement of major data management deliverables and milestones in coordination with the Clinical Operations Clinical Development, Biostatistics & Programming, Biomarker Operations & Sample Management and Pharmacovigilance.
Plan and manage external Data Management budgets and timelines to ensure accuracy, understand trends in variances and support continuous improvement in forecasting.
Act as a process expert for operational and oversight models.
Maintain Standard Operating Procedures (SOPs), process maps and templates and timelines to support functions operational and oversight models.
May prepare metrics to support the function Key Performance Indicators (KPIs).
Represent function in external professional initiatives and organizations such as SCDM, CDISC, and DIA to identify industry best practice and increase the visibility of Moderna.
Lead functional Continuous Improvement initiatives, providing strategic direction and identifying key deliverables that meet timelines, budget, and are in alignment with requirements.
Work cross-functionally to ensure the quality of the data in each database and on time delivery, as well as quality of other data management deliverables.
Champion and adopt technology improvements and tools for use in clinical data management processes.
Ensure compliance with own Learning Curricula, corporate and GXP requirements.
Qualifications
Requires a Bachelor’s degree, or foreign equivalent, in Biotechnology, Biology, Biological Sciences, or related field.
8 years of progressive, post-baccalaureate experience as a Sr. Manager, Assistant Clinical Data Manager, Clinical Data Associate or related position supporting clinical data management for the pharmaceutical industry.
7 years of experience must include:
Vendor Management
Medidata RAVE, InForm, and Oracle Clinical EDC tools
Clinical Data Management using Biomarker and External data
Utilizing eTMF tools
Study Database Lock processes including Final, Interim, Snapshots, DSUR submission, and Staggered Lock
Study Initiation, CSR Review, and SAE Reporting
J-Review, I-Review, and Clinbrowser
SDTM and CDISC datasets, Clinical Data Studio, SQL & SAS
Requirements
100% telecommuting permitted from anywhere within the US.
Benefits
Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs.
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support.
Family planning benefits, including fertility, adoption, and surrogacy support.
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown.
Savings and investment opportunities to help you plan for the future.
Location-specific perks and extras.
The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.
