Current jobs related to Sr. Clinical Trial Manager, Clinical Operations, Therapeutics - Cambridge, Massachusetts - Moderna
-
Lead Clinical Operations Manager
4 weeks ago
Cambridge, Massachusetts, United States Pheon Therapeutics Full timePosition Overview:Pheon Therapeutics is seeking a dedicated Senior Clinical Trial Manager / Associate Director to work closely with the Head of Clinical Development. This role is essential for ensuring effective operational oversight and support for all clinical trial initiatives, including vendor management and oversight from the initiation phase through to...
-
Clinical Trial Operations Manager
2 weeks ago
Cambridge, Massachusetts, United States Simcere Zaiming Full timeAbout Simcere Zaiming:Simcere Zaiming is a pioneering pharmaceutical company dedicated to advancing healthcare through cutting-edge research and innovative therapies. With a focus on oncology drug development, we are committed to improving the lives of patients in China and worldwide. Our culture values sincerity, collaboration, result orientation, and a...
-
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeCompany OverviewBicycle Therapeutics is a pioneering biopharmaceutical organization focused on developing innovative therapeutic solutions through its unique Bicycle molecules. These fully synthetic short peptides, constrained by small molecule scaffolds, are designed to effectively target diseases that lack adequate treatment options. The company is...
-
Cambridge, Massachusetts, United States Relay Therapeutics Full timeAbout the RoleWe are seeking an experienced professional to lead our Clinical Trial Engagement and Awareness efforts for our breast cancer program. As a key member of our team, you will be responsible for developing and executing a comprehensive strategy to drive awareness and enrollment of our clinical trials.Key ResponsibilitiesDevelop and Execute Clinical...
-
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeCompany OverviewBicycle Therapeutics is a pioneering biopharmaceutical organization focused on developing innovative therapies, known as Bicycle molecules, aimed at addressing unmet medical needs. These fully synthetic peptides, constrained by small molecule scaffolds, exhibit high affinity and selectivity for their targets, making them promising candidates...
-
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeCompany OverviewBicycle Therapeutics is a pioneering biopharmaceutical organization focused on developing a unique class of therapeutic agents known as Bicycle molecules. These fully synthetic short peptides are designed with small molecule scaffolds, creating two loops that enhance their structural stability. This innovative design allows for high-affinity...
-
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeCompany OverviewBicycle Therapeutics is a pioneering biopharmaceutical organization focused on creating innovative therapies known as Bicycle molecules. These fully synthetic peptides are designed to address unmet medical needs in various diseases. Our leading candidates include BT8009, BT5528, and BT7480, all undergoing rigorous clinical trials. We are also...
-
Clinical Trial Manager
7 days ago
Cambridge, Massachusetts, United States Simcere Zaiming Full timeJob Title: Clinical Trial ManagerCompany Overview:Simcere Zaiming is a pioneering pharmaceutical company dedicated to advancing healthcare through cutting-edge research and innovative therapies. With a focus on oncology drug development, we are committed to improving the lives of patients in China and worldwide. Our culture values sincerity, collaboration,...
-
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeCompany OverviewBicycle Therapeutics is a pioneering biopharmaceutical organization focused on developing innovative therapies known as Bicycle molecules. These fully synthetic peptides are designed to address medical conditions that lack effective treatments. Our research includes advanced candidates such as BT8009, BT5528, and BT7480, all undergoing...
-
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeCompany OverviewBicycle Therapeutics is a pioneering biopharmaceutical organization focused on developing innovative medicines, known as Bicycle molecules, for conditions that lack effective treatments. These fully synthetic short peptides are designed with small molecule scaffolds, creating a unique structure that enhances their ability to bind to targets...
-
Senior Manager of Clinical Quality Assurance
7 days ago
Cambridge, Massachusetts, United States Moderna Therapeutics Full timeAbout the RoleWe are seeking a highly skilled Senior Manager of Clinical Quality Assurance to join our team at Moderna Therapeutics. As a key member of our Quality Assurance department, you will play a critical role in ensuring the compliance of our clinical trials with Good Clinical Practice (GCP) regulations.Key ResponsibilitiesDevelop and implement...
-
Clinical Quality Assurance Manager
4 weeks ago
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeJob OverviewCompany Overview:Bicycle Therapeutics is a pioneering biopharmaceutical organization focused on developing innovative therapies, known as Bicycle molecules, aimed at addressing unmet medical needs. These molecules are synthetic short peptides structured with small molecule scaffolds, designed to enhance target binding with exceptional affinity...
-
Clinical Development Physician
5 days ago
Cambridge, Massachusetts, United States Moderna Therapeutics Full timeAbout the RoleWe are seeking a highly skilled Clinical Development Physician to join our team at Moderna Therapeutics. As a key member of our Clinical Development department, you will be responsible for developing, executing, and leading clinical studies supporting one or more development programs in the Infectious Disease department.Key...
-
Clinical Quality Assurance Manager
3 weeks ago
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeJob OverviewCompany Overview:Bicycle Therapeutics is a pioneering biopharmaceutical organization focused on developing innovative therapies known as Bicycle molecules. These fully synthetic short peptides are uniquely designed with small molecule scaffolds that create two loops, enhancing their ability to bind to targets with high affinity and selectivity....
-
Clinical Biomarkers and Oncology Program Manager
2 weeks ago
Cambridge, Massachusetts, United States Moderna Therapeutics Full timeAbout the RoleModerna Therapeutics is seeking a highly skilled and experienced Senior Manager, Clinical Biomarkers and Oncology to join our team. This is a critical role that will be responsible for developing and driving biomarker plans across clinical stage Oncology programs.Key ResponsibilitiesDevelop and implement biomarker plans for clinical stage...
-
Clinical Quality Assurance Manager
4 weeks ago
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeJob OverviewCompany Overview:Bicycle Therapeutics is a pioneering biopharmaceutical organization focused on creating innovative therapies, known as Bicycle molecules, for conditions that lack effective treatments. These molecules are synthetic short peptides designed with small molecule scaffolds, forming loops that enhance their structural stability. This...
-
Cambridge, Massachusetts, United States Leap Therapeutics Full timeJob SummaryLeap Therapeutics is seeking a highly experienced Senior Director, Clinical Data Management to lead our clinical data management function. This role will be responsible for the strategic leadership and functional management of all CDM deliverables in adherence to company SOPs and ICH/GCP.Key ResponsibilitiesStrategic Leadership: Provide high-level...
-
Cambridge, Massachusetts, United States Leap Therapeutics Full timeAbout the RoleLeap Therapeutics is seeking a highly experienced Senior Director, Clinical Data Management to lead our Clinical Data Management function. This role will be responsible for the strategic leadership and functional management of all CDM deliverables in adherence to company SOPs and ICH/GCP.Key ResponsibilitiesData Management Oversight: Oversee...
-
TMF Operations Manager
7 hours ago
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeJob Title: Manager, Trial Master File OperationsBicycle Therapeutics is seeking a highly skilled and experienced Manager, Trial Master File Operations to join our Clinical Operations team. As a key member of our team, you will be responsible for the oversight of projects for TMF Technology within the Clinical Operations group.Key Responsibilities:Subject...
-
Clinical Trials Specialist
2 weeks ago
Cambridge, Massachusetts, United States Bristol Myers Squibb Full timeJob SummaryBristol Myers Squibb is seeking a highly skilled Clinical Scientist to join our team. As a Clinical Scientist, you will be responsible for designing and executing clinical trial activities, working closely with clinical team members to execute activities associated with the conduct of clinical trials.Key ResponsibilitiesDesign and execute clinical...
Sr. Clinical Trial Manager, Clinical Operations, Therapeutics
3 months ago
The Role:
The Senior Clinical Trial Manager (Sr.
CTM) provides clinical 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 reports to the Director, Clinical Operations.
This role may work collaboratively on one trial or across several trials to support clinical operations activities. This position will focus on rare disease, but in the future may work across programs and studies within Therapeutics.
Here's What You'll Do:
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 Moderna's values
Here's What You'll 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
Experience with early phase complex global trials required. Rare disease experience required. Diverse trial experience across phases and multiple therapeutic areas desirable (oncology, autoimmune/ immune mediated, cardiovascular).
Bachelor's degree required; Advanced degree preferred
Relevant experience in global setting, across more than one phase of development, and across entire lifecycle of a study
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
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
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture.
Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit to learn more about our current opportunities.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society.
We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at (EEO/AAP Employer)