Job Description

Clinical Study Manager - Contract - Durham, NC -remote

Proclinical 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:

• USD 50-59 per hour

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at [email protected]

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

INDCR

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