About The Position

This position leads the operational planning and execution of one or more clinical trials or significant aspects of a trial. The Study Manager works as part of a global, cross-functional team, applying project management, communication, and collaboration skills in support of clinical trials. The role is based primarily in Rahway, New Jersey, has a 10% travel requirement, and is designated as a first-shift, day position. Relocation is not offered.

Requirements

  • Bachelor's degree and 5 or more years of pharmaceutical, clinical drug development, project management, and/or medical field experience; or master's degree and 3 or more years of such experience; or a PhD/PharmD degree.
  • Solid knowledge of clinical research regulatory requirements, such as Good Clinical Practice (GCP) and International Council for Harmonisation (ICH).
  • Ability to manage multiple competing priorities with planning, time management, and prioritization skills.
  • Solid understanding of project planning and project management principles.
  • Analytical skills to drive operational milestones.
  • Ability to influence opinions and decisions of internal and external customers and vendors across functional areas and within the division.
  • Ability to interact with stakeholders across departments, divisions, and the company, and to take a proactive, leadership-driven approach toward study goals.
  • Leadership skills for processes and meetings, and ability to influence peers in a matrix environment.
  • Problem-solving, prioritization, conflict-resolution, and critical-thinking skills.
  • Strong communication, writing, and presentation skills.
  • Intermediate knowledge of Microsoft Office or similar tools, including Excel, PowerPoint, Word, and Outlook.
  • Required skill: Program Management.

Nice To Haves

  • A degree in life sciences is preferred.

Responsibilities

  • Lead the operational planning, feasibility, and execution of a clinical trial.
  • May serve as the clinical trial team lead.
  • May lead study planning, development, and execution activities, including data management deliverables, trial-level plans and timelines, country and site selection, site materials, system updates, investigator meeting planning, communication plans, status update reports, and study closeout activities.
  • Lead timeline management, risk identification and mitigation, and issue resolution.
  • Facilitate and collaborate with internal and external stakeholders, including study teams, country and site teams, vendors, and committees, in support of clinical study objectives.
  • Manage study-specific partners and/or vendors.

Benefits

  • Medical, dental, vision healthcare, and other insurance benefits for employees and family.
  • Retirement benefits, including 401(k).
  • Paid holidays, vacation, compassionate days, and sick days.
  • Eligible for an annual bonus and long-term incentive, if applicable.
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