Senior Clinical Project Manager - Lexington, United States - Novo Nordisk

Description

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Novo Nordisk

Senior Clinical Project Manager

in

Lexington ,

Massachusetts

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 a Senior Clinical Project Manager (CPM).

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.

The Senior CPM will be responsible for all aspects of clinical trial management aimed at treating a rare or infectious liver-targeted disease.

You will be responsible for the successful execution of clinical trials from protocol finalization through closeout.
Relationships

Reports to:
Associate Director or Director of Clinical Operations.
Essential Functions
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 Program 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 Dicerna 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
Qualifications
Bachelor's degree in a scientific discipline is required
Minimum of 8 years of clinical development experience in the pharmaceutical industry
At least 3-5 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
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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