Associate Director, Clinical Study Lead
New
I
Immunic TherapeuticsBiotechnology, Pharmaceutical
Remote - USFull-TimeDirector
Salary$180K - $210K
Apply NowOpens the employer's application page
Job Details
- Languages
- English
- Experience
- Typically 7+ years of pharmaceutical, biotechnology, or CRO experience, including at least 6 years of clinical research experience
- Required Skills
- Budget management
Requirements
- Bachelor's degree or higher in nursing, life sciences, health sciences, or related discipline.
- 7+ years of pharmaceutical, biotechnology, or CRO experience.
- At least 6 years of clinical research experience with increasing responsibility.
- Demonstrated experience managing Phase 1-3 clinical studies from start-up through close-out.
- Experience working in a fully or substantially outsourced operating model including CRO oversight.
- Strong working knowledge of ICH-GCP, FDA, and EMA regulatory requirements.
- Proven ability to manage complex timelines, budgets, and risks in a global matrix organization.
- Excellent written and verbal communication skills in English.
- Willingness and ability to travel domestically and internationally.
Responsibilities
- Provide operational leadership for the planning, start-up, conduct, maintenance, and close-out of assigned global studies or regions.
- Serve as the principal Clinical Operations representative on cross-functional study teams.
- Develop, review, and maintain integrated study execution plans, enrollment plans, oversight plans, and operational trackers.
- Contribute operational input to protocols, informed consent forms, eCRFs, and clinical study reports.
- Lead or oversee country and site feasibility, site selection, activation, training, enrollment, and close-out activities.
- Manage CRO and vendor selection, performance, governance, and invoice reconciliation.
- Monitor study performance through KPIs and risk management plans.
- Ensure sponsor oversight activities are documented and inspection-ready including eTMF management.
- Provide technical guidance, coaching, and mentoring to junior team members.
View Full Description & ApplyYou'll be redirected to the employer's site
