Regional Clinical Study Manager - Investigator Initiated Studies (Home-based) at Pharmaceutical Research Associates, Inc.

Posted in Health Care 28 days ago.

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Location: Raleigh, North Carolina





Job Description:
Pharmaceutical Research Associates, Inc.

Regional Clinical Study Manager - Investigator Initiated Studies (Home-based)

US-Remote


Job ID: 2019-54620
Type: US
# of Openings: 1
Category: Clinical Trial Management

Genentech

Overview

We believe that our people are the future of the industry. We provide a culture in which our employees can enjoy personal satisfaction, professional achievement and have the ability to strategically map out long-term career plans. If you're ready to be a part of something inspiring join us and Discover Your PRA.

Who are we?

We Are PRA.

We are 16,000+ employees strong, operating in more than 90+ countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.



Responsibilities

What will you be doing?

  • Acts as lead contact for regional and or/project matters.
  • Understands/manages/satisfies client contractual, organizational and relationship needs/expectations.
  • Provides regular reporting on project metrics, status of deliverables and risks/issues with the associated
  • management plan to client.
  • Chairs and leads client meetings.
  • Leads and directs cross-functional team leaders and third parties/vendors with some supervision and support:
  • Contributes to development, maintenance and approval of project plans. Guides and supports team leads in
  • prioritizing, trouble-shooting and contingency planning.
  • Contributes to development, maintenance and approval of project plans. Guides and supports team leads in
  • prioritizing, trouble-shooting and contingency planning.
  • Delegates whilst retaining ownership.
  • Communicates project specific priorities.
  • Liaises with functional leads/managers to optimize performance and utilization of project team members.
  • Manages project contractual deliverables:
  • Supervises progress via metrics.
  • Monitors and ensures adherence to the contractual agreement (time, quality/scope, and cost deliverables).
  • Leads presentation of internal project status reviews and is accountable for action item follow up.
  • Proactively identifies, resolves/mitigates and escalates risks and/or issues.
  • Manages project costs:
  • Owns projections of units/hours (revenue and resources), actual units/hours efficiency analysis.
  • Proactively and timely identifies, for assigned projects, ensuring out of scope activities are approved
  • upfront via a contract modification.
  • Identifies potential or actual unrecoverable hours and provides analysis and mitigation/resolution plan for
  • senior management’s approval.
  • Ensures control of financial risk to PRA.
  • In cooperation with the project analyst, applies efficient management of project pass-through costs and
  • investigators payments to ensure all such costs are recovered in a timely manner, and in advance where
  • ever possible.
  • Leads presentation of financial reviews and is accountable for action item follow up.
  • Ensures adherence to company SOP, policies and guidelines at the project level.
  • Assumes project leadership role in compliance at project level to PRA processes and systems including escalation
  • to relevant functional and operational management.
  • Participation and attendance in bid defense process.
  • Provides feedback on project team member’s performance to respective line-managers.
  • Detailed understanding of each functional service area and is able to lead multifaceted functional teams effectively
  • with little supervision or support.
  • Mentoring of other members of the project management team or functional leads, as required.
  • Develops in depth analysis and projections of project timelines and financials for senior and customer
  • management with little to no supervision.


Qualifications

  • Minimum 3 years experience in clinical research, including a management role as a team lead or project manager experience.
  • Reads, writes and speaks fluent English; fluent in language of host country.
  • Experience working with/managing Investigator Initiated Studies - Highly preferred
  • Experience working with Investigator Initiated Studies required
  • An undergraduate degree.

  • An undergraduate degree with 5 years of experience in clinical research and at least 2 years as a functional team lead role or single service project management - Highly preferred
  • Graduate degree with 3 years of experience in clinical research and at least 1 year as a functional team lead role or single service project management - Highly preferred



To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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