Senior Clinical Program Manager

19 hours ago

Atlanta, Georgia, United States VIVEX BIOLOGICS INC Full time
Job Title: Senior Clinical Program Manager

At VIVEX Biologics, we are seeking a highly skilled Senior Clinical Program Manager to join our team. As a key member of our clinical operations department, you will be responsible for overseeing the execution of multiple clinical studies, ensuring compliance with quality standards, and driving the development of evidence to support business objectives.

Key Responsibilities:
  • Oversee the execution of studies in compliance with quality standards, on schedule, and on budget.
  • Manage CROs and other third-party vendors to meet obligations described in ICH-GCP and business objectives.
  • Provide oversight, support, and guidance to CROs to ensure study issues are addressed and resolved promptly.
  • Champion operational feasibility, inclusive of patient and site burden, and timelines that meet the needs of the clinical development plan.
  • Assist in planning and operational strategy and execution for planned clinical trials.
  • Provide subject matter expertise and operational input into protocol synopsis, final protocol, and other study-related documents.
  • Assist in study budget planning and management and be accountable for external spend related to study execution.
  • Liaise with project teams to ensure that budgets, enrollment, and gating are accurate; track study status, cost, and issues for communication to Program Leads.
Requirements:
  • Bachelor's degree or international equivalent required. Life Sciences preferred. Master's degree in a relevant discipline preferred.
  • Ten or more years' experience in the pharmaceutical or medical device industry and/or clinical research organization, including 7+ years of clinical study management.
  • Experience in more than one therapeutic area is advantageous.
  • Excellent communication, teamwork, organizational, interpersonal, and problem-solving skills.
Working Conditions:

Office Environment, Laboratory Environment.

Physical Requirements:

While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift, and/or move up to 20 pounds.

VIVEX Biologics is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status.

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