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-basedLead 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 j.cerchio@proclinical.com

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