6 часов назад
Manager, Clinical Site and Participant Experience (CSPE)
133 000 - 173 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Manager, Clinical Site and Participant Experience (CSPE) (Clinical Trials): Improving clinical trial experiences for sites and participants by building site relationships, resolving issues, and incorporating participant and caregiver feedback into study planning with an accent on reducing site and participant burden. Focus on engaging clinical trial sites, supporting protocol and Schedule of Assessments development, measuring participant engagement and satisfaction, and coordinating with global clinical functions.
Location: Hybrid role based out of the Bridgewater, New Jersey office; remote work is available most of the time with in-person collaboration as needed. Occasional domestic and international travel of approximately 15% is required.
Salary: $133,000–$173,000 annual
Company
is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases.
What you will do
- Build and maintain relationships with clinical trial sites to improve performance, engagement, enrollment, and partnership with .
- Serve as the central point of contact for site issue resolution and provide high-touch support.
- Provide site feedback for clinical trial site selection and qualification activities.
- Support site coordinator protocol advisory boards, including discussion guides and outcome summaries.
- Partner with Clinical Study Teams and Compliance to incorporate participant and caregiver feedback and develop compliant participant-engagement approaches.
- Assess participant burden and clinical trial performance using objective measures such as burden indices, engagement goals, and satisfaction metrics.
Requirements
- Bachelor’s degree and at least 6 years of progressive experience in Clinical Operations or Development Operations at a sponsor or CRO.
- At least 3 years of experience as a Clinical Trial Site Engagement Lead.
- Understanding of end-to-end clinical trial processes and clinical trial regulations and guidelines, including GCP, FDA, and EMA requirements.
- Experience building clinical trial site relationships, influencing stakeholders, negotiating, resolving conflicts, and solving problems.
- Ability to collaborate in a global, multifunctional matrix and work with North American sites while understanding European operations.
- Strong written and verbal communication, organization, critical thinking, judgment, decision-making, and attention to detail.
Nice to have
- Advanced degree.
Culture & Benefits
- Medical, dental, and vision coverage, mental health support, wellbeing reimbursement, and Employee Assistance Program access.
- Paid time off, fertility and family-forming benefits, caregiver support, and flexible work schedules.
- 401(k) with company match, annual equity awards, Employee Stock Purchase Plan, and company-paid life and disability insurance.
- Learning resources, workshops, leadership programs, mentorship, and networking opportunities.
- Employee resource groups, service and recognition programs, volunteering, and community engagement opportunities.
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