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AD, Case Management - Basking Ridge, NJ #6904734

Company: MedFocus

Date: 10/12/2019

Category: Energy and Utilities

City: Basking Ridge, NJ

Job Description:
Job Title: Associate Director, Case Management

Case Processing: Interacts with vendors, CROs, and partners on a daily and as-needed basis.
Escalates issues and develops resource strategy with senior management.

Vendor Case Management: Lead for PV CRO/vendor projects and ongoing management oversight. Monitors CRO/vendor reports (daily, weekly, monthly as required by project) to ensure quality completion of deliverables.
Responds to and manages escalated issues. Identifies and arranges for CRO/vendor training as needed. Works with Strategic Partner Management Lead to manage relationship with CROs and Vendors.

PV Representative on Study Teams: PV contact for study teams as needed and oversees staff assignments on study teams. May attend multidisciplinary study team meetings and provide management oversight of initiatives and trouble shooting.
Participates in Study Start up activities related to case processing as needed. Represents PV for review and comment on interdepartmental and CRO/vendor and partner projects.

Case Processing Training: Reviews and approves case processing training materials.
Aggregate Reports: Participates in the preparation of routine and ad hoc Case Processing Compliance and Volume Reports. Oversees PV role in local and global aggregate reports and partner reporting requirements.

Skills: 1. Creates a culture of compliance for the function: works cross-functionally to identify risks and trends for the function.

  1. Owns functional strategic plans, defines and manages priorities within the function and drives implementation.
  2. Identifies issues independently, thoroughly understands cause of issues, recognizes functional and global impact, and oversees implementation of solutions.
  3. Uses advanced scientific knowledge to influence PV processes and provide cross-functional leadership.
  4. Interfaces, collaborates and negotiates with internal and external stakeholders to ensure successful results and resolution to complex issues.
  5. Drives timely management decisions, appropriately shifts functional timelines, resources and priorities to address regional priorities.
  6. Applies clinical trial knowledge to promote efficiency and compliance for assigned projects within the function with both internal and external stakeholders.
    Education: Bachelor’s degree in nursing, pharmacy, or health care related field; minimum of five (5) years of management experience in PV; minimum of twelve (12) years of Drug Safety / Pharmacovigilance experience, including both investigational and marketed products; Extensive knowledge of AE and drug coding conventions (MedDRA, WHO-DD); extensive knowledge of FDA and familiarity with ROW regulations, clinical and safety databases; Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP).
    Languages: English Read Write Speak

Please send resume to

City: Basking Ridge

State: NJ

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