Associate Director - Clinical Operations
Novo Nordisk
- Lexington, MA
- Permanent
- Full-time
- 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, clinicaltrials.gov)
- 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
- 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