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Clinical Trial Manager, Clinical Operations, Infectious Disease

Company: Moderna Therapeutics
Location: Cambridge
Posted on: January 16, 2022

Job Description:

Clinical Trial Manager, Clinical Operations, Infectious Disease 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 trial Communication to internal team members on deliverables and ensuring timelines are met Manage trial feasibility process Work closely with study Clinical Operations Lead and/or assigned Clinical Trial Manager(s) to execute clinical studies Drafting site materials including training, manuals and support documentation Monitoring of clinical data to ensure timely entry and readiness for data review meetings Periodic review of clinical data Review of clinical monitoring reports to ensure timely completion and identification of issues Ensure trial samples are ready to be sent to vendors in order to meet trial deliverables Maintain trial metrics Ensure trial is conducted in accordance with Moderna and ICH/GCP standards including multiple regions in global trials Support testing clinical trial systems/databases (i.e. UAT) May support additional clinical trial(s) in an unblinded Clinical Trial Manager capacity Develop and maintain strong, collaborative relationships with key stakeholders within Moderna Here's What You'll Bring to the Table: At least 5 five years of trial coordination experience in a clinical research and industry environment Advanced degree preferred or Bachelor's in a science-based subject Relevant experience in global setting Solid understanding of drug development Good understanding of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies Excellent verbal and written communication skills Good organizational skills and attention to detail Here's What We'll Bring to the Table:

  • On-site subsidized cafeteria or 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) 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 10 years since its inception, -Moderna -has transformed from a science 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 six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. -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 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 auto-immune 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-TR2 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 M oderna 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 is committed to providing access to employment opportunities to all qualified individuals with disabilities, including disabled veterans. -Reasonable accommodation is a modification or adjustment to a job, the work environment, or the way things are usually done during the hiring process. These modifications enable a qualified individual with a disability to have an equal opportunity not only to get a job, but successfully perform their job tasks to the same extent as people without disabilities. - Consistent with our non-discrimination and accommodation policies, any applicant who needs an accommodation in connection with the hiring process or to perform the essential functions of the position for which the applicant has applied may make a request for accommodation to the recruiter or receive further information by calling +1-617-460-9346 or emailing humanresources@modernatx.com . This contact is intended for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process or technical assistance. The Reasonable Accommodation Process, following the guidelines established by the ADAAA, is a collaborative and interactive process between the applicant or employee, Human Resources, the manager, and/or subject matter experts.

Keywords: Moderna Therapeutics, Cambridge , Clinical Trial Manager, Clinical Operations, Infectious Disease, Executive , Cambridge, Massachusetts

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