Clinical Trial Associate

  • location: Cambridge, MA
  • type: Contract
  • salary: $115 - $127.27 per hour
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job description

Clinical Trial Associate

job summary:

Job Title: Associate Director, GPSE Strategy and Business Planning III

Position Description

  • This position is responsible for helping to further the strategic advancement of GPSE in support of GPSE's mission to ensure patient safety. Primary responsibilities include but are not limited to:

    • Leading key initiatives that have cross-functional impact and that are critical to GPSE's business objectives and/or Company's global business objectives. This includes integration activities related to acquisitions, mergers and divestments.
    • Provides expert project/program management and leadership skills to ensure internal, cross-functional, cross-divisional project plans are in place for GPSE related initiatives. This includes providing strategic direction and translating the cross-divisional, integrated GPSE strategy into an executable plan using innovative approaches to ensure rapid and effective decision making
    • Work directly with the GPSE Head, Chief of Staff (COS), GPSE Leadership Team, and outside departments to support the strategic direction of GPSE by leading high-impact, high-priority projects and overseeing department-wide initiatives.
    • Support functional resourcing oversight using financial forecasting and headcount management techniques to drive operational excellence.
Position Responsibilities

  • Enable GPSE to be a successful partner in due diligence activities by creating a Due Diligence Center of Excellence; author and maintain due diligence SOPs, tools, templates, and other related resources.
  • Liaise with other GPSE functions and Business Development to support due diligence reviews of target companies' Pharmacovigilance System, infrastructure, and organization.
  • Lead or support integration projects for M&As, which may include representing GPSE on cross-functional integration teams. Directly manage and/or liaise with appropriate SMEs on all aspects of the GPSE integration, including project plans & timelines, budget, personnel transitions, safety systems migrations, etc.
  • Proactively identify and drive project and resource priorities that align with global business objectives. Work closely with stakeholders to balance operational execution with GPSE strategy
  • Support transformational project/initiatives and change-management activities.
  • Identify and execute opportunities for infrastructure enhancements and efficiencies, including process improvement.
  • Develop and implement tools and templates to enable consistency and transparency across GPSE projects.
  • Liaise with Company's Vaccine Business Unit to prepare for GPSE support of postmarketing vaccine activities.
  • Manage and track GPSE budget and FTE resources along with GPSE Chief of Staff, including yearly mid-range planning efforts with Global Finance, comprehensive FTE capacity planning, monthly headcount reconciliation, and GPSE travel oversight.
  • Support GPSE outsourcing initiatives and vendor engagement, including strategic future-state planning. Work with stakeholders to identify and support implementation of opportunities for efficiency gains.
  • Contribute to GPSE goal and KPI development, initiative tracking and prioritization, and team engagement activities.
  • Represent pharmacovigilance department in cross-functional teams and/or meetings at a regional and global level as required, alongside the commensurate communication skills required.
  • Utilize project and program management expertise to drive project teams to achieve clarity on issues and focus on effective contingencies; interface with management and influence decision-making, monitor progress, gaps, risk management to ensure progress and business continuity
Position Requirements

  • Bachelors required. Post-graduate degree or equivalent (Masters Degree/MBA) preferred
  • Experience in Alliance Management - both with external business partners/vendors, and with internal key stakeholders and colleagues. Ability to interact effectively with staff of multiple disciplines both within and outside the company both nationally and internationally
  • Experience in program and/or project management, preferably in the Pharmaceutical or Biotech industry in clinical development, regulatory affairs, pharmacovigilance, or related function.
  • Strong ability to proactively identify areas for process improvement and lead infrastructure-related projects efficiently and within given time constraints
  • An understanding of and experience in the drug development process, including post-marketing and life-cycle management, with a focus on drug safety/pharmacovigilance
  • Experience in and knowledge of due diligence for company acquisitions and/or licensing partnerships
  • Demonstrated ability and experience leading high performing teams internally and cross functionally in a global highly matrixed and collaborative environment
  • Ability to proactively identify and anticipate project risks, including those associated with non-adherence to the regulations, and a keen understanding of when to escalate issues quickly and efficiently
  • Strong understanding and knowledge of the business areas both internally within the organization and touch points externally
  • Excellent time management skills
  • Self starter and strategic thinker
  • Able to lead teleconferences and meetings
  • Ability to drive change and manage complex situations, particually with multinational matrix teams
  • Proven ability to create and implement operational efficiencies
  • Excellent oral and written communication skills
  • Strong relationship management skills
  • Ability to handle confidential information appropriately
  • Routine demands of an office based environment.
  • Estimated 5-10 travel times per year, including possible international travel.

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

location: Cambridge, Massachusetts
job type: Contract
salary: $115.00 - 127.27 per hour
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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