Clinical Site Lead (remote)
Novo Nordisk
2 months ago
Remote
United States
Clinical Research and Development
Responsibilities
- Operationally manage clinical site performance for assigned trials by coordinating and communicating with CSSAs, CRAs, and the Trial Manager (TM)
- Deliver clinical trial improvement/innovation projects aligned to business needs and global/local goals
- Oversee trial site performance across the lifecycle (start-up, recruitment, retention, quality, data entry, etc.), tracking trends and reporting key metrics
- Support audits and inspections with the Trial Manager (prepare for, conduct support, follow-up)
- Collaborate with NACD/CMR teams and global partners, providing input and guidance
- Coordinate and drive site selection and start-up/activation activities, including SSV/SIV training tools and materials development
- Drive monitoring activities during maintenance; coordinate deliverables for DBL and trial closure
- Lead Trial CORE Team meetings and other relevant teams
- Review/approve monitoring visit reports; ensure issues are escalated appropriately
- Identify/escalate risks to trial delivery and contribute to mitigation plans
- Develop trial-level communications with key updates
- Provide active coaching, mentorship, and training contributions for NACD staff
Qualifications
- Bachelor’s degree required (relevant industry experience may substitute where appropriate)
- 6+ years designing, planning, and conducting GCP clinical trials; 4+ years direct site management and logistical clinical trial execution in pharma/biotech/CRO required
- On-site monitoring experience preferred
Required skills/knowledge
- Expert in ICH-GCP principles and their application to trial design, planning, and conduct
- In-depth knowledge and direct experience/interactions with the FDA (or equivalent regulatory authority)
- Excellent verbal, written, and presentation communications in English
- Demonstrated collaboration and stakeholder management
- Foundational skills in designing and implementing innovation/improvement initiatives, including change management
Benefits
- Base compensation range: $99,600–$184,200; eligible for company bonus
- Long-term incentive compensation and/or company vehicles (level-dependent)
- Medical, dental, vision; life insurance; disability insurance; 401(k); flexible spending accounts; employee assistance program; tuition reimbursement; voluntary benefits (e.g., group legal, critical illness, identity theft protection, pet insurance, auto/home insurance)
- Time off (sick time, flexible vacation) and parental leave
Application instructions
- If you need special assistance/accommodation to apply, call 1-855-411-5290 (accommodation requests only).
- Operationally manage clinical site performance for assigned trials by coordinating and communicating with CSSAs, CRAs, and the Trial Manager (TM)
- Deliver clinical trial improvement/innovation projects aligned to business needs and global/local goals
- Oversee trial site performance across the lifecycle (start-up, recruitment, retention, quality, data entry, etc.), tracking trends and reporting key metrics
- Support audits and inspections with the Trial Manager (prepare for, conduct support, follow-up)
- Collaborate with NACD/CMR teams and global partners, providing input and guidance
- Coordinate and drive site selection and start-up/activation activities, including SSV/SIV training tools and materials development
- Drive monitoring activities during maintenance; coordinate deliverables for DBL and trial closure
- Lead Trial CORE Team meetings and other relevant teams
- Review/approve monitoring visit reports; ensure issues are escalated appropriately
- Identify/escalate risks to trial delivery and contribute to mitigation plans
- Develop trial-level communications with key updates
- Provide active coaching, mentorship, and training contributions for NACD staff
Qualifications
- Bachelor’s degree required (relevant industry experience may substitute where appropriate)
- 6+ years designing, planning, and conducting GCP clinical trials; 4+ years direct site management and logistical clinical trial execution in pharma/biotech/CRO required
- On-site monitoring experience preferred
Required skills/knowledge
- Expert in ICH-GCP principles and their application to trial design, planning, and conduct
- In-depth knowledge and direct experience/interactions with the FDA (or equivalent regulatory authority)
- Excellent verbal, written, and presentation communications in English
- Demonstrated collaboration and stakeholder management
- Foundational skills in designing and implementing innovation/improvement initiatives, including change management
Benefits
- Base compensation range: $99,600–$184,200; eligible for company bonus
- Long-term incentive compensation and/or company vehicles (level-dependent)
- Medical, dental, vision; life insurance; disability insurance; 401(k); flexible spending accounts; employee assistance program; tuition reimbursement; voluntary benefits (e.g., group legal, critical illness, identity theft protection, pet insurance, auto/home insurance)
- Time off (sick time, flexible vacation) and parental leave
Application instructions
- If you need special assistance/accommodation to apply, call 1-855-411-5290 (accommodation requests only).