About The Position

This position leads the operational planning and execution of one or more clinical trials or significant aspects of clinical trials. The Study Manager demonstrates leadership and technical skills 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. It includes 10% travel and a first-shift (day) schedule. Flexible work arrangements are not applicable. Relocation assistance is not offered, and visa sponsorship is not available.

Requirements

  • Bachelor's degree and 5 or more years of pharmaceutical, clinical drug development, project management, and/or medical field experience; or a master's degree and 3 or more years of such experience; or a PhD or PharmD degree.
  • Solid knowledge of clinical research regulatory requirements, including 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, take a proactive approach, and provide leadership toward study goals.
  • Leadership skills for managing processes, leading meetings, and influencing 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.
  • Program management skills.

Nice To Haves

  • Degree in life sciences.

Responsibilities

  • Lead operational planning, feasibility, and execution of a clinical trial.
  • May serve as the clinical trial team lead.
  • May lead team 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.
  • May facilitate and collaborate with internal and external stakeholders, including study teams, country and site teams, vendors, and committees, to support clinical study objectives.
  • Manage study-specific partners and/or vendors.

Benefits

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