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Remote Visit Project Manager (RVPM)

Chicago, IL

Posted: 06/17/2019 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 2377

The Remote Visit Project Manager (RVPM) is responsible for oversight and management of in-home study visits. The RVPM may be an employee or a contractor may fill this role for any given period of time.

Responsibilities:
  • Managerial Responsibilities
    • Comply with the Quality Management System (Quality Manual, SOPs).
    • Track objectives and key performance indicators (KPIs) relating to the Remote Visit services.
    • Provide guidance, mentorship, and direct management for Remote Visit Associates (RVAs) that may be assigned to your project.
  • Department Responsibilities
    • Oversee and participate in clinical tasks and study activities.
    • Ensure effective project plans are in place and operational for each trial and work proactively with the assigned team to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
    • Manage the activities relating to the identification, contracting, training, and management of in-home nursing agencies and their providers.
    • Oversee inventory sourcing, tracking/coordination, and management of shipments.
    • Establish and maintain Sponsor/CRO, Central Lab, and Agency communication.
    • Organize and lead Sponsor/CRO, Central Lab, and Agency teleconferences.
    • Develop and implement internal process improvement initiatives.
    • Serve as the point of contact for Sponsor or Sites for any questions, issues, and escalations.
    • Proactively manage project level operational aspects and deliverables including management of trial timeline, budget, resources and vendors.
    • Ensure potential study risks and potential risk mitigating solutions are escalated to the attention of the VP, Remote Visit Services when appropriate.
    • Provide leadership and support to project staff in the review and approval of patient visit reports/documents; ensure tracking, follow up and resolution of any open issues have been completed in a timely manner.
    • Review and approve vendor invoices in collaboration with the Accounting team to ensure payments occur in a timely manner
    • Participate in and act as key contributor to initiatives and advancement of the organization, as appropriate.
    • Escalate quality concerns or customer complaints to QA, as appropriate

Required Skills and Experience:
  • Bachelor’ s degree or equivalent is required, typically in nursing or scientific field. Advanced degree is desirable.
  • At least 2 years of direct clinical research experience including experience in managing and completing clinical trials from pre-study activities through study completion and data summarization. Phase 2 or Phase 3 experience is required. Global experience strongly preferred. Experience in multiple therapeutic areas or disease state/indications desirable.
  • Current knowledge of and the ability to apply ICH/GCP and all applicable regulations and guidelines.
  • Responsibility for cross-functional clinical program management required. Client management desired.
  • Must have demonstrated a high level of core and technical competencies of a Sr. CRA or equivalent and demonstrated potential for leadership.
  • Must have demonstrated ability to independently execute a clinical study from study start through completion. Must have demonstrated experience in planning, managing and completing multiple or complex studies or equivalent experience. Proven track record of successful studies (delivered on time, within budget, and with high quality).
  • Competent in application of standard business procedures (SOPs, Global Regulations, OEC, Outsourcing).
  • Management of employees, mentoring, oversight providing issue escalation and resolution, oversight of project, team management.
  • Well organized and able to multi-task.
  • Positive and energetic attitude.
  • Able to drive a team to work both independently and as a team.
  • Able to give clear and concise directives. Professional, well spoken, articulate.
  • Extensive experience with Service Provider identification and training (as appropriate).
  • Extensive experience with Country Coordinator training (as appropriate).
  • Demonstrates leadership.

Sam Williams
Clinical Recruiter

Sam brings great enthusiasm and a passion for the life sciences to his role as Clinical Recruiter for The Steely Group. Outgoing and driven with a great sense of humor, Sam connects easily with people and prides himself on his ability to cultivate lasting relationships. He values honesty, communication and empathy in a candidate, and has a genuine interest in helping others achieve their professional goals.

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