4 дня назад
Senior Clinical Trial Manager (Clinical Operations)
145 600 - 218 400$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Senior Clinical Trial Manager (Clinical Operations): Leading global Phase I–IV clinical trials with an accent on cross-functional execution, vendor oversight, budgets, timelines, documentation, and GCP compliance. Focus on managing complex trial risks, regulatory requirements, audits, clinical teams, and operational strategy across the study lifecycle.
Location: Remote/Home-Based for US-based candidates; Philadelphia, Pennsylvania is listed as the role location.
Base salary: $145,600–$218,400 annually for US-based candidates.
Company
is a global biopharmaceutical company developing medicines for serious diseases, with a focus on oncology, neuroscience, sleep disorders, and epilepsy.
What you will do
- Lead global Phase I–IV clinical trials across strategy, execution, governance, and operational delivery.
- Coordinate cross-functional teams, study meetings, service providers, vendors, and escalation management.
- Manage trial timelines, budgets, vendor spend, risks, contingencies, and patient recruitment strategies.
- Oversee the Trial Master File, essential trial documents, clinical systems, archiving, and regulatory documentation.
- Review and approve protocols, informed consent forms, monitoring plans, Clinical Study Reports, and other key documents.
- Lead audit and inspection activities, investigator meetings, process initiatives, and clinical operations improvements.
Requirements
- 7+ years of clinical research experience, including global trial management and at least 3 years in clinical operations leadership.
- Strong knowledge of clinical trial processes, ICH-GCP, regulatory requirements, and study start-up planning.
- Experience managing global, multicenter clinical trials in cross-functional environments.
- Experience with clinical trial systems such as TMF and CTMS, plus proficiency in Microsoft Office.
- Excellent project management, organization, communication, stakeholder management, and senior-level influencing skills.
- Bachelor’s degree in life sciences, healthcare, or a related field, or equivalent experience.
Nice to have
- Advanced degree.
- Experience mentoring Global Study Managers, Clinical Research Associates, and Global Study Associates.
Culture & Benefits
- Remote/home-based work arrangement for the US role.
- Eligibility for a discretionary annual cash bonus or incentive compensation.
- Potential eligibility for discretionary equity grants.
- Medical, dental, and vision insurance.
- 401(k) retirement savings plan and flexible paid vacation.
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