Associate Director/ Director, Clinical Data Standards and Integration

The Role:

Reporting to the Senior Director, Clinical Data Management, this person will be responsible for leading the initiative to utilize internal and external partners Develop and maintain a Moderna Data Standards Governance to ensure proper utilization of standards and adherence to standards processes across clinical development.

Here's What You'll Do:

• Responsible for developing and promoting the strategy and infrastructure for the creation, maintenance, and implementation of data standards across all therapeutic areas.
• Builds relationships across the Moderna organization and with CRO partners in support of the standards vision and implementation to support data alignment across functional areas and within each therapeutic area.
• Leads implementation of data standards practices within vendor relationships.
• Identifies and drives data standards related initiatives to enhance efficiencies within the data flow. Evaluates data standards and governance processes and metrics for continuous improvement opportunities.
• Consult with CRO and vendor partners to establish current and forward-looking standardized electronic Case Report Forms (eCRFs).
• Collaborate with CRO partners and Moderna Informatics to develop an automatized, streamline process to deliver data, data metrics and/or data outputs from multiple sources (e.g. EDC, CTMS, IVRS, etc.) to the Moderna Data Repository and/or clinical metrics tool.
• Collaborate with CRO partners to utilize reporting functionality from EDC or vendor software, such as reporting functions from Medidata's Rave including use of Business Objects, J-Review, and /or SAS on Demand to develop standard reports to be used within a TA or across a TA.
• Ensure that data delivery specifications and/or data import agreements are aligned with data tools; for example, subject data housed in clinical databases, metadata aligned with performance metrics, vendor data such as tissue and/or laboratory data.
• Provide support to the therapeutic areas, as needed, for data tool training and user access alignment for all internal and external data platforms.

Here's What You'll Bring to the Table:

• Bachelor's Degree in computer science or a science-based subject; or Bachelor's Degree outside of computer science or a science-based subject with a minimum of 12 years of data science, data analysis or clinical data management experience in industry, with experience across indications and EDC platforms
• Deep understanding of drug development and biopharmaceutical Industry required
• Extensive knowledge of standards, regulatory and drug submission requirements and current regulatory trends Including global landscape; including thorough command of FDA and ICH GCP guidelines to ensure the appropriate reporting of clinical trial data
• Strong management skills, and ability to effectively lead and collaborate with various business functions
• Demonstrates leadership, problem solving, conflict resolution, and team building skills
• Demonstrated ability establish effective business relationships with external stakeholders, including implementing process change at a vendor
• Proven ability to manage multiple competing priorities
• Strong technical skills across data platforms
• Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology.
• Experience with Spotfire or other data visualization software
• Outstanding verbal and written communication skills, in addition to excellent organizational skills
• Experience in regulatory GCP inspections/audits

Here's What We'll Bring to the Table:

• Daily on-site catered lunches
• Company-provided iPhone
• Free parking, monthly subway pass or a subsidized commuter rail pass
• Free annual corporate membership to Bluebikes
• Highly competitive healthcare coverage including: medical offered through BCBS (HMO/PPO), dental, and vision offered through VSP
• Flexible Spending Accounts for medical expenses and dependent care expenses
• 16 weeks of 100% paid parental leave for all new parents
• 16 weeks 100% paid family caregiver leave
• 20 weeks 100% paid medical leave
• Eligible for "Moderna Month" (one month paid sabbatical after five years of service and eligible for additional one month paid sabbatical every 3 years thereafter)
• Adoption assistance and discounts to local childcare centers, as well as access to care.com
• 401k (traditional and Roth offered) with 50% match on first 6% deferred. Match is vested immediately
• A suite of Moderna paid insurance coverage, including: life insurance, short-term and long-term disability
• Voluntary legal assistance plan
• 15 days' vacation and 7 sick days per year, in addition to a discretionary winter shut down and 11 company paid holidays (includes 2 floating holidays)

Why join Moderna:

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that have a therapeutic or preventive benefit with the potential to address a broad spectrum of diseases. Moderna's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca, Plc. and Merck, Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been named a top employer by Science for the fifth year in a row. To learn more, visit www.modernatx.com .

Our Mission:
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.

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Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.