Clinical Research Program Manager I

SHIFT:

Day (United States of America)

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A Brief Overview

The Clinical Program Manager I will work with Steve Willi, MD, Director of the Diabetes Center and his team. Dr. Willi’s research focuses primarily on clinical trials on the treatment and to delay the progression of type 1 and type 2 diabetes in children. Program Manager I functions autonomously in research setting and is responsible for overseeing all research studies for Dr. Willi in the Diabetes Center for Children.

Provides leadership and ensures implementation of study activities and site management for CHOP and all other participating study sites. Will supervise staff.

This position requires technical expertise and experience to operationalize, mentor, and guide team members through the entire study lifecycle, from conception through execution and termination. Ability to perform all clinical research coordination activities and additional oversight responsibilities as required.

What you will do

• Supervision, training, support, and management of staff (direct and/or indirect) to ensure compliance with study protocol, NIH and FDA policies.
• Work collaboratively and effectively with the individual study management teams, various core groups at CHOP’s Research Institute and other participating institutions.
• As part of Management Team, develop, review, and update program policies and procedures as needed.
• Serve as primary liaison between research and other hospital staff to carry out the needs of the research project(s).
• Assist with analysis of data and preparation of manuscripts and scientific presentations, as needed.
• Track regulatory compliance of CHOP and other sites.
• Oversee financial resources, create internal and external budgets for research protocols, assure financial accountability, and serves as primary liaison between sponsor, department accounting, and Research.
• Applied knowledge of Good Clinical Practice (GCP) guidelines including protection of human research subjects with particular emphasis on pediatrics, definitions and reporting requirement for adverse events, elements of informed consent, Federal Codes, Regulations and Guidelines relevant to the performance and conduct of clinical trials.
• Provide supervision and support for other clinical research coordinators and or/ monitors who are assigned to specific protocols and who will help with the overall clinical research of the program.
• Provide a leadership role in developing, implementing, and evaluating the conduct of clinical research.
• Responsible for Regulatory compliance for clinical research program.
• Critically evaluate decisions on staffing, finances, and regulatory needs for the study lifecycle.
• Additional responsibilities may include
• Responsible for preparation or overseeing preparation of necessary Data Safety Monitoring Board reports.
• Serve as the primary contact for trial for internal and external participants.
• Education Qualifications
• Bachelor's Degree Required
• Master's Degree in a related field Preferred
• Experience Qualifications
• At least five (5) years of relevant & complex research experience Required
• At least seven (7) years of relevant & complex research experience Preferred
• At least one (1) year of leadership, management or supervisory experience Required
• At least three (3) years of leadership, management or supervisory experience in a clinical research or academic environment Preferred
• At least three (3) years of research administration or management experience, including budget administration, financial planning, and grants management Preferred
• Skills and Abilities
• Excellent verbal and written communications skills
• Excellent interpersonal skills
• Excellent customer service skills
• Excellent time management skills
• Strong critical thinking / problem-solving skills
• Strong project management skills
• Strong organizational skills
• Strong analytical skills
• Solid leadership skills
• Ability to maintain confidentiality and professionalism
• Ability to work independently with minimal supervision
• Ability to convey complex or technical information in an easy-to-understand manner
• Ability to collaborate with stakeholders at all levels
• Ability to be flexible and adaptable to change
• To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must receive an annual influenza vaccine. Learn more.
• EEO / VEVRAA Federal Contractor | Tobacco Statement