- Oversee performance of CROs, third party vendors, and contractors, including co-monitoring, to ensure compliance with study protocol, and identifying areas of concern and escalating to Clinical Program Lead when appropriate
- Collaborate with the Clinical Trial Lead and study team to develop patient recruitment strategies, operational feasibility and implementation of study objectives
- Develop study plan(s) including key milestones and timelines
- Ensure country and site selection meet study requirements
- Participate in the development and testing of clinical systems (e.g., data capture, IxRS)
- Ensure internal and external systems are updated in a timely manner (e.g., trackers, )
- Manage critical study documents, such as consent forms, study manuals, subject recruitment materials
- Oversee the Trial Master File (TMF) and assist with periodic audit of the TMF
- Drive critical clinical trial activities including trial site activations, recruitment, and database lock
- Assist in contract and budget negotiations with clinical sites and vendors as well as budget review and forecasting
- Independently manage interactions with clinical monitors, data management, safety, regulatory, pharmaceutical science and QA team members, both internally and externally
- Participate in the development of tools and metrics for monitoring clinical study progress and surveillance of key efficacy and safety data points
- Collaborate with other functions (at CRO or internally) to ensure robust plans for study level data review, including trend evaluation
- Provide input in internal/external study related audits, review resulting reports
- Review monitoring reports and, if applicable, corrective action plans at individual sites and provide oversight to ensure safety concerns are identified and responses developed
- Communicate trial status, issues, and mitigations to relevant cross-functional stakeholders
- Represent Novo Nordisk during site initiation visits, trainings, close out visits, and conduct co-monitoring visits as needed
- Train study team members, external monitors, and site staff as needed Physical Requirements 20% overnight travel required. Qualifications
- Bachelor's degree is required; in a scientific discipline is preferred
- Minimum of 8 years of clinical development experience in the pharmaceutical industry with management experience
- At least 5 years of experience as a Clinical Trial Manager
- Experience with global clinical trial operations, in multiple phases of research
- Strong knowledge of ICH guidelines, GCP and FDA regulations
- Experience with all aspects of trial and site startup and vendor management
- Experience in rare disease, pediatric, and/or complex clinical trials preferred
- Ability to deal with multiple priorities with aggressive timelines
- Strong oral and written communication skills
- Ability to find creative solutions to issues impacting timelines and budgets
- Willingness to travel domestically and internationally We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
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Associate Director - Lexington, United States - Novo Nordisk
Description
About the Department
Our Boston Research & Development hub, anchored in the greater Boston area, brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown and Cambridge reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. Our greater Boston R&D hub merges biotech speed and agility with large pharmaceutical company quality, resources,and stability, uniting the best of both worlds to develop new medicines for patients.
The Position
We are looking to hire an Associate Director of Clinical Operations. This is a unique opportunity to work in a growing Clinical Operations Department that manages multiple early-stage clinical programs based on an innovative RNAi technology platform. This role will be responsible for all aspects of clinical trial management aimed at treating a rare liver-targeted disease. You will be responsible for the successful execution of clinical trials from protocol finalization through closeout.
Relationships
This position reports to the Vice President, Clinical Operations.
Essential Functions
