Clinical Study Manager - Contract - Durham, NC -remote
探花合集 is seeking a dedicated and proactive Clinical Study Manager to join a pharmaceutical company. This is a remote role in Durham, NC.
Primary Responsibilities:
The successful candidate will be responsible for planning and executing clinical studies in accordance with FDA & ICH-GCP regulatory requirements. You will also coordinate with support vendors, CROs, and other partners to ensure efficient execution of the clinical studies. This role requires a strong commitment to achieving study-specific goals and meeting the expectations of internal stakeholders.
Skills & Requirements:
- Strong background in study execution.
- Experience in working with global/regional teams or changes impacting multiple geographies.
- Proven track record of delivering on-time clinical research milestones.
- Desire to be part of a multifunctional team to problem-solve and work toward shared goals.
- Strong communications and influencing skills.
- Bachelor's level degree or equivalent.
- Interest in working in an entrepreneurial environment.
The Clinical Study Manager's responsibilities will be:
- Oversee and ensure timely, budget-friendly, and quality study delivery using a risk-based
- Lead and oversee operational activities and study execution by building relationships with vendors, sites, and other key stakeholders.
- Develop, maintain, and execute functional strategies and plans, including training, communication, device management, data management, document management, and quality documents.
- Conduct appropriate training of country staff and sites on protocol and project-specific matters.
- Manage vendor activities, including selection and contract development.
- Serve as a key clinical operations contact for internal and external teams for assigned studies.
- Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and our SOPs for assigned studies.
- Track and manage site engagement in recruitment activities to identify proactive solutions and maintain consistent screening activity.
- Communicate appropriately with stakeholders, including study status, expectations, risks, and issues.
- Lead quality efforts to ensure study compliance and continual inspection readiness for assigned studies.
Compensation:
If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at j.cerchio@proclinical.com
探花合集 is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
探花合集 Staffing is an equal opportunity employer.
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