We are seeking an experienced
Senior Clinical Trial Manager (Sr CTM). Reporting to the VP of Clinical Operations, the Sr CTM will be responsible for the end-to-end management of global, multi-center Phase I/II/III clinical trials.
Key Responsibilities:The Sr CTM will help ensure the successful conduct of clinical trials in adherence to clinical protocols, SOPs, ICH-GCP, and other relevant regulatory requirements. Key responsibilities are included below.
- Study Oversight: Lead the planning, set-up, execution, and close-out of Phase I-III clinical trials.
- Vendor Management: Select and manage CROs, central labs, and other third-party vendors, ensuring all deliverables meet quality standards.
- Timeline & Budgeting: Develop, manage, and track study budgets and timelines; ensuring adherence to financial and operational targets.
- Protocol Development: Collaborate with Clinical Development to draft and finalize study protocols, Informed Consent Forms (ICFs), and other key study documents.
- Risk Mitigation: Proactively identify potential study risks (e.g., slow enrollment, data quality issues) and implement mitigation and corrective action plans.
- Compliance: Ensure "inspection-ready" Trial Master Files (TMF) and compliance with ICH GCP and regulations.
- Cross-functional collaboration: lead or participate in study team meetings and cross-functional working groups as needed to support clinical trial activities.
Qualifications & Skills:- Bachelor's degree (BS/BA) in a life science or related field
- 7-10+ years of clinical operations experience, including leadership of global Phase II/III trials.
- Exceptional verbal and written skills for presenting study updates to executive leadership.
- Ability to work independently and collaboratively in a fast-paced environment.
- Strong project management and organizational skills, demonstrating ability to get answers and solve problems with a "get it done attitude"
- Proven vendor and CRO management skills.
- Strong knowledge of ICH-GCP, FDA, EMA, and other relevant regulations.
- Experience managing global, multi-center studies.
- Therapeutic experience in rare diseases and/or CNS (strongly preferred)
Travel Requirements- Willingness to travel up to 30%, including international travel as required for site visits, audits, and meetings.
Nura Bio offers a comprehensive and generous benefits package, including medical, dental, and vision insurance, life and disability insurance, health savings and flexible spending accounts (including dependent care), a 401(k) plan, and highly attractive stock options.
Recruitment Agency Notice:The company does not accept unsolicited resumes from recruitment agencies. Please do not forward resumes to employees or hiring managers. The company will not be responsible for any fees related to unsolicited resumes.
