6 дней назад
Associate Director, Clinical Trial Operation (Biotech)
164 000 - 213 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Associate Director, Clinical Trial Operation (Biotech): Leading phase I-IV clinical trials from protocol concept through Clinical Study Report with an accent on cross-functional study leadership, vendor oversight, data quality, and patient-centric execution. Focus on applying risk-based quality management, integrating digital health and eClinical technologies, and managing complex global trials within budget and regulatory requirements.
Location: Fully remote; can be performed from anywhere. Occasional domestic and international travel of approximately 25% is expected for team meetings, events, and other business needs.
Salary: $164,000–$213,000 annual
Company
is a global biopharmaceutical company developing treatments for patients with serious and rare diseases.
What you will do
- Lead and oversee phase I-IV clinical trials from protocol concept through Clinical Study Report.
- Establish and lead cross-functional Clinical Study Teams, including CTMs, CTAs, CROs, laboratories, sites, and other vendors.
- Manage trial execution, timelines, budgets, metrics, KPIs, risk management, and vendor performance.
- Create, review, and approve study documents, training materials, operational manuals, and study plans.
- Apply Risk-Based Quality Management principles to protect data integrity and patient safety.
- Drive the adoption of digital health and eClinical technologies and champion patient-centric trial design.
Requirements
- Bachelor’s degree in life sciences, healthcare, or a related field.
- 7+ years of clinical trial management experience with a sponsor company across multiple clinical phases.
- Experience conducting global clinical trials across multiple therapeutic areas.
- Experience managing clinical trial budgets, forecasting, accruals, invoicing, CROs, vendors, and laboratories.
- Excellent written and verbal communication, critical thinking, organization, problem-solving, collaboration, and leadership skills.
- Ability to work in compliance with ICH GCP and relevant regulatory guidelines.
Nice to have
- Experience with rare diseases or orphan indications.
- Experience managing a development program and participating in NDA or sNDA filings.
Culture & Benefits
- Fully remote work with connection to the team and community.
- Medical, dental, vision, and mental health coverage, plus wellbeing reimbursement and an Employee Assistance Program.
- Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
- 401(k) with company match, annual equity awards, ESPP, and company-paid life and disability insurance.
- Learning programs, mentorship, employee resource groups, recognition programs, and volunteer opportunities.
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