(Contract) Clinical Trial Manager, Clinical Operations, COVID Programs

Company: ModernaTX
Location: Cambridge
Posted on: June 23, 2022

Job Description:

The Role:This position will be located in Cambridge, MA. The Clinical Trial Manager provides clinical trial oversight to the assigned clinical trial(s) ensuring deliverables are met in terms of quality, compliance and timing. Strong vendor management is critical for this role. external vendors and CROs.The position reports to the Director, Clinical Operations and is accountable to the Clinical Operations Lead for assigned studies.This role may work collaboratively on one trial or across several trials to support clinical operations activities.Here's What You'll Do:Day to day management of assigned clinical trial(s) to ensure deliverables are met in all phases of trialCommunication to internal team members on deliverables and ensuring timelines are metManage trial feasibility processWork closely with study Clinical Operations Lead and/or assigned Clinical Trial Manager(s) to execute clinical studiesDrafting site materials including training, manuals and support documentationMonitoring of clinical data to ensure timely entry and readiness for data review meetingsPeriodic review of clinical dataReview of clinical monitoring reports to ensure timely completion and identification of issuesEnsure trial samples are ready to be sent to vendors in order to meet trial deliverablesMaintain trial metricsEnsure trial is conducted in accordance with Moderna and ICH/GCP standards including multiple regions in global trialsSupport testing clinical trial systems/databases (i.e. UAT)May support additional clinical trial(s) in an unblinded Clinical Trial Manager capacityDevelop and maintain strong, collaborative relationships with key stakeholders within ModernaHere's What You'll Bring to the Table:At least 5 five years of trial coordination experience in a clinical research and industry environmentAdvanced degree preferred or Bachelor's in a science-based subjectRelevant experience in global settingSolid understanding of drug developmentGood project management skillsGood understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studiesExcellent verbal and written communication skillsGood organizational skills and attention to detailCandidates 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 ModernaIn 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-CH1

Keywords: ModernaTX, Cambridge , (Contract) Clinical Trial Manager, Clinical Operations, COVID Programs, Executive , Cambridge, Massachusetts