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Clinical Trials Manager
at Nemours Children's Health System
Wilmington, DE

Clinical Trials Manager
at Nemours Children's Health System
Wilmington, DE

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Description

As one of the nation’s leading pediatric health care systems, Nemours is committed to providing all children with their best chance to grow up healthy. We offer integrated, family-centered care to more than 300,000 children each year in our pediatric hospitals, specialty clinics and primary care practices in Delaware, Florida, Maryland, New Jersey and Pennsylvania. Nemours strives to ensure a healthier tomorrow for all children – even those who may never enter our doors – through our world-changing research, education and advocacy efforts. At Nemours, our Associates help us deliver on the promise we make to every family we have the privilege of serving: to treat their child as if they were our own. 

The Nemours NCI Community Oncology Research Program (NCORP), is seeking an experienced Clinical Trials Manager, located in Wilmington, DE, to oversee the planning and execution of the daily clinical research operations. Due to the nature of this position, the employee will travel approximately 25%. This position will work closely with NCORP Administrator to provide a cross-campus team with study-level strategies, timelines, goal tracking, and quality initiatives that will enhance the organizations oncology research processes and infrastructure.  The candidate must maintain a high standard of professionalism, and confidentiality in this role and must be able to problem solve, communicate effectively, and trouble-shoot creatively.

Qualifications:

  • Masters degree strongly preferred; Bachelors degree with appropriate experience may be acceptable.  
  • As a guide, 5+ years’ experience relevant clinical research (or related) experience within the pharmaceutical industry or other Oncology research base.

Primary Duties:

The Clinical Trials Manager will manage and ensure coordination of the following functions:

  • Provide guidance, direction, and support to the clinical research nurses, coordinators, assistants and regulatory staff.  Will be the direct manager for approximately 7-10 associates.
  • Participate in operational process improvement initiatives, including training, standard operating procedure review and development of work instructions/tools/templates.
  • Lead the team(s) in key study planning, development and execution elements such as: data management deliverables, protocol level plans/timelines, communication plans, preparation of status update reports, study closeout activities.
  • Anticipates, recognizes, and manages issues: Analyze clinical study and investigative site risks and implements corrective actions, where required.
  • Provides support for inspection readiness activities for Children’s Oncology Group (COG) Research Base, industry sponsored trials and other applicable regulatory body audits and/or meetings.
  • Communicates trial status with internal and external study team members to ensure cross-functional alignment of expectations, priorities, and deliverables.
  • Assist with protocol feasibility and protocol review committee.
  • Generates and maintains timelines, milestones and action items.
  • Management of clinical trials with multiple vendors and complex protocols.
  • Excellent understanding of all tasks involved in opening a clinical trial from site selection, IRB/CIRB submission, eligibility criteria, site monitor visits and study close out.
  • Ability to organize and manage multiple priorities (institutional and staff related).
  • Excellent communication skills; able to provide constructive feedback to staff.
  • Oversight of the operational aspects of all stages of clinical studies.
  • Adheres to Professional Standards of Behavior.

Strategic Planning and Development:

  • Communicates trial status within and outside the study team to ensure cross-functional alignment of expectations, priorities and deliverables.
  • Meet with the medical staff and faculty on a regular basis to assess their needs pertaining to clinical trials research.
  • Develop goals and performance measures to ensure growth and development of the clinical trials program as well as the staff.
  • Meet regularly with the NCORP Administrator (located in Delaware) to provide feedback on new initiatives, performance of on-going initiatives/staff, and seek feedback for future programmatic development.

Supervision and Oversight:

  • Plans and leads execution of the day to day activities for the monitoring of a clinical study across the enterprise.
  • Communicates consistently with the clinical team providing project objectives, expectations and status updates
  • Evaluates/documents staff performance, sets annual goals for staff, rounds with staff at a minimum quarterly.
  • Ensures staff are in line with the Nemours standards of behavior.
  • Track staff competencies, ongoing training, and certifications.

Our dedication to professionals who are dedicated to children frequently earns Nemours a spot on the list of top workplaces in the communities we serve. Our Associates enjoy comprehensive benefits, including our unique “Bridge to a Healthy Future” pediatric health plan, an integrated wellness program, opportunities for professional growth, and much more. As an equal opportunity employer, Nemours focuses on the best-qualified applicants for our openings.

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