Cambridge, Massachusetts, United States · Remote OK
$131k–$209k/yr
The Role: 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. Respon…
Skills: Vendor Management, Clinical Data Management, Medidata RAVE, InForm, Oracle Clinical
Harwell, England, United Kingdom · Hybrid
The Role: Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. This is an opportunity to…
Skills: Ligand Binding Assays, Cell Based Assays, Pharmacodynamic Data Analysis, Immunogenicity Testing, GcLP Compliance
Norwood, Massachusetts, United States · Hybrid
$131k–$209k/yr
The Role The Candidae will report to and work closely with the Director, Digital LIMS Systems to ensure the implementation of new solutions and improvement of existing systems (LabVantage) for the Moderna Digital Laborat…
Skills: LabVantage LIMS, LIMS Development, GxP, GMP, Computer Systems Validation
Cambridge, Massachusetts, United States · Hybrid
$167k–$301k/yr
The Role Joining Moderna offers the unique opportunity to be part of a pioneering team that is revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. Mo…
Skills: Salesforce Platform Management, CRM Implementation, Enterprise Architecture, Data Governance, DevOps
Cambridge, Massachusetts, United States · Hybrid
$146k–$234k/yr
The Role: Moderna is seeking a Senior Technical Program Manager (TPM) to drive project and program management of infrastructure (cloud and on-prem) rationalization and AI-readiness initiatives at Moderna globally. We’re …
Skills: Program Management, Infrastructure Engineering, Cloud Modernization, ITSM, Stakeholder Management
Cambridge, Massachusetts, United States · Hybrid
$143k–$257k/yr
The Role Moderna continues to expand its innovative mRNA platform, unlocking new applications across diseases and therapeutic areas. As the company advances its oncology pipeline, including a personalized mRNA therapy in…
Skills: Commercial Operations, Launch Readiness, Sales Force Effectiveness, Oncology Commercialization, Marketing Operations
Cambridge, Massachusetts, United States · Hybrid
$225k–$405k/yr
The Role Moderna continues to expand its innovative mRNA platform, unlocking new applications across diseases and therapeutic areas. As the company advances its oncology pipeline, including a personalized mRNA therapy in…
Skills: Oncology Sales Leadership, Field Force Design, Alliance Management, Product Launch Execution, Account Penetration Strategy
Princeton, New Jersey, United States · Hybrid
$143k–$257k/yr
The Role Moderna is seeking an Individual to help design, scale, and modernize global Digital Commercial capabilities across SAP S/4HANA, logistics execution, pricing, billing, invoicing, integrations, data, analytics, a…
Skills: SAP S/4HANA, SAP SD, Solution Architecture, Order-to-Cash, Logistics Execution
Princeton, New Jersey, United States · Hybrid
$143k–$257k/yr
The Role Moderna is seeking a SAP Inventory-to-Delivery Lead to design, scale, and support global logistics execution, inventory movement, 3PL integration, warehouse connectivity, cold chain distribution, transportation …
Skills: SAP S/4HANA, SAP Logistics Execution, SAP SD-LE, Inventory Management, 3PL Integration
Harwell, England, United Kingdom · Hybrid
The Role: Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. At Harwell, you will help…
Skills: Laboratory Automation, Liquid Handling, Hamilton VENUS, REST APIs, Python
Harwell, England, United Kingdom · Hybrid
The Role: Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. At Harwell, you will play…
Skills: Cell-based Immunoassays, Assay Validation, Clinical Sample Analysis, GLP/GCP Compliance, Cell Culture
Norwood, Massachusetts, United States · On-site
$74k–$118k/yr
The Role: Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. Moderna is strengthening …
Skills: Cell Culture, Bioassays, ELISA, Immunoassays, Aseptic Technique
Cambridge, Massachusetts, United States · Hybrid
$159k–$286k/yr
The Role: This role will support Oncology Therapeutic programs, specifically supporting the Clinical Development Lead in the direction, execution and evaluation of Phase 1-3 clinical studies. The principal responsibility…
Skills: Clinical Study Design, Oncology Knowledge, Clinical Data Review, Regulatory Submissions, Medical Safety Monitoring
Harwell, England, United Kingdom · Hybrid
The Role: Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. This role sits at the for…
Skills: Ligand Binding Assays, Immunogenicity, Anti-drug Antibody Assays, Neutralizing Antibody Assays, GcLP Compliance
Toronto, Ontario, Canada · Hybrid
The Role Reporting to the Director, Global Clinical Operations (GCO) Business Analytics & Operations Management (BAOM), the Senior (Sr.) Manager, Site Budgets & Contracts will focus on the generation and review of invest…
Skills: Site Budget Creation, Contract Negotiation, Grants Manager, GrantPlan, Financial Analysis
Warsaw, Mazowieckie, Poland · Hybrid
If you’re interested in this role, please apply in English and include an English version of your Resume/CV. The Role Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing m…
Skills: Contract Drafting, Contract Negotiation, Biotech Law, Pharmaceutical Law, Regulatory Alignment
Harwell, England, United Kingdom · Hybrid
The Role: Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. This role is based in Oxf…
Skills: Spectral Flow Cytometry, GCLP, Immunophenotyping, PBMC Isolation, Ex Vivo Assays
Harwell, England, United Kingdom · Hybrid
The Role: Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. This role is based at Mod…
Skills: RT-qPCR, dPCR, NGS, Molecular Assay Development, GCLP
Cambridge, Massachusetts, United States · Hybrid
$143k–$257k/yr
The Role Associate Director, Clinical Supplies Project Management is responsible for oversight and leadership of clinical supply activities for a program and/or a clinical study. The scope includes the operational planni…
Skills: Clinical Supply Management, Demand Planning, Cold Chain Distribution, IRT Implementation, Vendor Oversight
Laval, Quebec, Canada · On-site
Résumé du Poste Se joindre à Moderna, c’est faire progresser la science de l’ARNm pour transformer la médecine. Travaillez avec des équipes mondiales exceptionnelles sur un vaste portefeuille de programmes et bâtissez un…
Skills: EHS Management Systems, Risk Assessment, Regulatory Compliance, Biosafety, Environmental Permitting
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Lead clinical data management activities for in-house and outsourced studies, ensuring high-quality deliverables and regulatory submission readiness. Manage vendor oversight, cross-functional alignment, and the creation of data review plans and database lock processes.
Requires a Bachelor's degree in Biotechnology, Biology, or a related field with at least 8 years of progressive experience in pharmaceutical clinical data management. Must have 7 years of specific experience with EDC tools, vendor management, CDISC standards, and database lock processes.
Moderna Services, Inc. seeks a Sr. Manager, Clinical Data Management for its Cambridge, Massachusetts location.
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 edit checks (data validation plan), listing review checks, data integration specifications, data transfer specifications, external data reconciliation plans, coding guidelines, Serious Adverse Events (SAE) reconciliation guidelines, and database lock plans.
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.
Requires a Bachelor’s degree, or foreign equivalent, in Biotechnology, Biology, Biological Sciences, or related field and 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; and
SDTM and CDISC datasets, Clinical Data Studio, SQL & SAS.
100% telecommuting permitted from anywhere within the US.
The salary range for this role is $130,800 to $209,400. This range reflects the lowest to highest salary we, in good faith, believe we would pay for this role at the time of this posting. The minimum target pay for this particular position, based on its primary location, is $196,400 to $209,400. An individual’s placement within the range will depend on several factors, including but not limited to specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.
Apply at https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx (Job ID: R19409) or email resume and cover letter to [email protected] with subject line: R19409.
At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.
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.
#dni
At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.
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.
Our mission is to deliver the greatest possible impact to people through mRNA medicines.
Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more. With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn. This Moderna page is not the appropriate place to report adverse events (side-effects) for any products. If you are or someone you know is experiencing a side effect, please reach out to your healthcare professional. Moderna is continuously monitoring the safety of its products. We encourage you to report any side effects directly to us at 1‑866‑MODERNA (1‑866‑663‑3762). Please be cautious of fraudulent recruitment offers claiming to be from Moderna. Recruitment scams of this sort may originate from fake websites, social media accounts, or unsolicited communications and may ask you for personal information or request you pay them or someone else. Moderna will never ask you for payment, banking information, or anything of this sort at any stage of the recruitment process. If you are unsure about a communication, do not provide personal information and report the activity to [email protected]. You may also report suspected fraud to the FBI’s Internet Crime Complaint Center (IC3).
Offices: 200 Technology Sq, Cambridge, Massachusetts 02139, US · 1 Upland Rd, Norwood, Massachusetts 02062, US
Our mission is to deliver the greatest possible impact to people through mRNA medicines.
Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more. With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X, Facebook, Instagram, YouTube and LinkedIn. This Moderna page is not the appropriate place to report adverse events (side-effects) for any products. If you are or someone you know is experiencing a side effect, please reach out to your healthcare professional. Moderna is continuously monitoring the safety of its products. We encourage you to report any side effects directly to us at 1‑866‑MODERNA (1‑866‑663‑3762). Please be cautious of fraudulent recruitment offers claiming to be from Moderna. Recruitment scams of this sort may originate from fake websites, social media accounts, or unsolicited communications and may ask you for personal information or request you pay them or someone else. Moderna will never ask you for payment, banking information, or anything of this sort at any stage of the recruitment process. If you are unsure about a communication, do not provide personal information and report the activity to [email protected]. You may also report suspected fraud to the FBI’s Internet Crime Complaint Center (IC3).
Offices: 200 Technology Sq, Cambridge, Massachusetts 02139, US · 1 Upland Rd, Norwood, Massachusetts 02062, US
