Sr. Clinical Trial Manager, Clinical Operations, PCV Oncology
- Moderna, Inc.
- Cambridge, MA
- Start date
- Mar 10, 2023
- Clinical, Clinical Research, Clinical Trials
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
- Genetown, Best Places to Work
The Senior Clinical Trial Manager (Sr. CTM) PCV Oncology provides clinical operations support to PCV partner trials as well as trial oversight to the assigned clinical trial(s), which may be complex or high priority, and ensures deliverables are met in terms of quality, compliance and timing. Strong vendor management is critical for this role. external vendors and CROs.The position may report to the Director, Clinical Operations, Oncology. This role maywork collaborativelyon one trial or across several trials to support clinical operations activities.
Heres What Youll Do:
This role will play a key role in clinical operations coordination, logistics and partner trial support across the personalized cancer vaccine ecosystem. The role is expected to be dynamic and therefore will require skill sets for trial management but also logistics coordination and working with a broad cross-functional team both within and external to the organization.
As part of PCV clinical operations support, liaise with clinical biomarkers, biomarker operations, CMC, manufacturing, and clinical supplies to support PCV to patient coordination and tracking for assigned clinical trials.
Work across internal and external facing workstreams, initiatives related to process improvements and optimization.
Perform day to day management and oversight of assigned clinical trial(s) to ensure deliverables are met in all phases of trial
Lead the Clinical Trial Team, and support other development teams as a Clinical Operations representative as required
Perform and document study level Sponsor Oversight of outsourced clinical activities
Communicate study-status, cost and issues to ensure timely decision-making by senior management
Initiate and manage study-level timelines, including communication to internal and external team members on deliverables
Work closely with other supporting clinical operations team members, if applicable, to execute clinical studies
Draft and/or oversee the drafting of site materials including training, manuals and support documentation
Review clinical data to ensure timely entry and readiness for data review meetings
Perform periodic review of clinical data, quality metrics and study deviations
Manage trial feasibility process and oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate
Review 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
Complete and maintain internal clinical trial metrics, dashboards and other internal updates
Ensure trial is conducted in accordance with Moderna and ICH/GCP standards including multiple regions in global trials
Participate in testing of clinical trial systems/databases (i.e. UAT)
Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities
May support additional clinical trial(s) in various capacities (e.g., unblinded clinical trial manager, regional clinical trial manager, etc.)
Participate in clinical operations workstreams related to departmental and operating model related initiatives Develop and maintain strong, collaborative relationships with key stakeholders within and external to Moderna
Strive for continuous improvement and more efficient ways of working in clinical development
Act as a role model for Modernas values
Heres What Youll Bring to the Table:
5-7 years of experience in a clinical research and industry environment, including a minimum of 2+ years of independent trial management preferred
Bachelors degree required; Advanced degree preferred
Robust oncology experience required. Desirable: late stage experience, immuno-oncology, high complexity such as CAR-T.
Solid understanding of drug development
Good project management skills
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
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.
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 persons 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
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.
mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”
Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.
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