Associate Director, Clinical and Biomarker Data Management

The Role: Moderna is seeking an Associate Director, Clinical Biomarker Data Management. This role will manage the sample reconciliation and well as data flow and transfers for the Infectious Disease TA, to ensure timely and quality data collection and data reporting throughout the clinical trial lifecycle as well as lead/participate in the implementation and adoption of innovative data management and processing systems and processes Here’s What You’ll Do: Ensures aligned expectations between external clinical biomarker data vendors and the Moderna cross-functional stakeholders for all clinical biomarker data cleaning related deliverables for Infectious Disease trials. Monitors the quality of clinical biomarker data deliverables for Infectious Disease trials; anticipates and mitigates the risks and measures the performance through metrics and KPIs Ensures that outsourced activities for clinical biomarker data cleaning vendors are delivered in line with the project expectations (timelines and quality) for Infectious Disease trials. Ensures achievement of clinical biomarker data management deliverables and milestones in coordination with cross functional team members including Biomarker Operations & Sample Management, Biostatistics & Programming, Clinical Operations, Clinical Development Defines, implements and monitors the biomarker clinical data management strategy, initiatives and efforts within Infectious Disease trials. Lead/participate in the implementation and adoption of innovative data management and processing systems, processes, procedures for the Infectious Disease TA and identify any needs for improvement. Participate in the continuous improvement of the Data Management system in support of timely, quality clinical biomarker data Lead/contribute to/participate in Moderna Clinical Data Management Initiatives, Innovation, and Implementation. Participate in the development and optimization of clinical data biomarker/ data management SOPs, processes, and initiatives. Support and collaboration with related cross-functional process definition Responsible for defining and implementing clinical biomarker data management standards and processes to be utilized across the Infectious Disease TA Responsible for overseeing and contributing to the development of Data Management documentation including Data Transfer Specifications; Data Validation Specifications, Data Handling Guidelines; etc for Infectious Disease TA. Here’s What You’ll Bring to the Table: Bachelor’s Degree in an analytical or health-related field 8 years of clinical data management experience in industry, with experience across indications and relational databases and experience using multiple clinical data management systems Experience with leading, implementing or adopting new technologies, systems or processes Knowledge of industry standards (CDISC, SDTM, ADaM, CDASH) Laboratory background and/or working knowledge of commonly tested biomarkers across a variety of different therapeutic areas including infectious disease, with latest and advanced analytics tool and assay experience preferred Previous LMS (Laboratory Information Management System) experience and working knowledge of the clinical drug development process. Prior experience with data transfers or management for diagnostics Thorough command of FDA and ICH GCP regulations and industry standards applicable to drug development systems Knowledge of regulations and best practices related to computer system validation, electronic records and signatures and data privacy. Outstanding verbal and written communication skills, in addition to excellent organizational skills Creative, capable problem-solver Experience in regulatory GCP inspections/audits Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations Successful experience managing vendor relationships Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including: Highly competitive and inclusive medical, dental and vision coverage options Flexible Spending Accounts for medical expenses and dependent care expenses Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities Family care benefits, including subsidized back-up care options and on-demand tutoring Free premium access to fitness, nutrition, and mindfulness classes Exclusive preferred pricing on Peloton fitness equipment Adoption and family-planning benefits Dedicated care coordination support for our LGBTQ community Generous paid time off, including: • Vacation, sick time and holidays • Volunteer time to participate within your community • Discretionary year-end shutdown • Paid sabbatical after 5 years; every 3 years thereafter Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning tools Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options Complimentary concierge service including home services research, travel booking, and entertainment requests Free parking or subsidized commuter passes Location-specific perks and extras! Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible. Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law. About Moderna In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic. Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com. 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. #LI-KS3 - 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