Associate Director, Clinical Data Management, Infectious Disease

The Role: Moderna Services, Inc. seeks an Associate Director, Clinical Data Mgmt, Infectious Disease for its Princeton, New Jersey location. Here’s What You’ll Do: Lead clinical data management efforts and initiatives for the Infectious Disease Therapeutic Area and support oversight of data management vendors and data handling. Represent the data management function for Infectious Disease trials and ensure aligned expectations between external data vendors and the Moderna cross- functional stakeholders for all data related deliverables. Ensure Electronic Data Capture system is built correctly to reflect the protocol requirements. Data vendor oversight activities including consistency, quality and timeliness of all deliverables across Infectious Disease in compliance with GCP, SOP and regulatory requirements. Ensure achievement of data management deliverables and milestones in coordination with cross functional team members including Clinical Operations, Clinical Development, Biostatistics & Programming, Biomarker Operations & Sample Management, and Pharmacovigilance. Lead the design, creation and testing and implementation of data capture tools and integrations for data capture, data processing, medical coding and validation in accordance with the data collection requirements as defined in the clinical protocol, in alignment with industry best practice guidelines and enforcement of Moderna data standards and processes. Author and oversee the development of all Clinical Data Management documentation including CRF Specifications, CRF Completion Guidelines, Data Validation Specifications, and Data Transfer Specifications. Lead the cross-functional data review for the Infectious Disease program, and support cross-functional team with tools and processes to successfully enable and achieve cross-functional data review. Manage clinical trial data through review, cleaning, auditing, validation procedures and ensure data handling compliance with regulatory requirements. Lead and participate in clinical data review and report on performance and quality. Review clinical data within studies and across for trend analysis. Lead cross-functional data review meetings including internal and external study team members; and ensure alignment of data delivery strategy for Infectious Disease trials. Ensure archival and inspection readiness of all Data Management Trial Master File (TMF) documents for Infectious Disease trials and ensure inspection readiness for data management. Contribute to Moderna Data Management Initiatives and Innovation Implementation. Participate in the development and optimization of data management SOPs, processes, and initiatives. Here’s What You’ll Bring to the Table: Minimum Requirements: Requires a minimum of a Bachelor’s degree, or foreign equivalent, in Pharmaceutical Science, Public Health, Biology, or related field and seven (7) years of progressive, postbaccalaureate experience as a Senior Manager of Clinical Data Management, Clinical Data Manager, Clinical Data Analyst, or related position involving clinical data management. Seven (7) years of experience must include: Electronic Data Capture System development and testing; Applying understanding of Clinical Data Interchange Standards Consortium (CDISC) and SDTM standards; Phase I-IV clinical development; Applying knowledge of FDA & International Council for Harmonization regulations for data capture and data management processes; Building and testing clinical study databases including Rave and integrating databases with Safety Gateway & Rave coder; and Utilizing Rave Modules, J Review, and Elluminate to run clinical study listings. May telecommute up to three (3) days per week. Position requires up to 5% domestic travel, fully reimbursed. The salary range for this role is $142,500 to $256,500. 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 $220,800 to $256,500. 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: R19158) or email resume and cover letter to careers@modernatx.com with subject line: R19158 Pay & Benefits 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 Pay & Benefits 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. Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. Third Party Staffing Agencies Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from those resumes. Reasonable Accommodation Notice Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing humanresources@modernatx.com if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Return Home