About The Position
This position leads operational planning, feasibility, and execution for one or more clinical trials or significant aspects of a trial. The Study Manager applies project management, communication, and collaboration skills as part of a global, cross-functional team. The role may serve as clinical trial team lead and may lead teams in study planning, development, and execution. It is based primarily in Rahway, New Jersey, with a first-shift schedule, 10% travel, and no relocation or visa sponsorship. Flexible work arrangements are listed as not applicable.
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/PharmD degree.
- Solid knowledge of clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Council for Harmonisation (ICH).
- Ability to manage competing priorities using 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.
- Proactive approach and leadership in driving toward study goals.
- Problem-solving, prioritization, conflict-resolution, and critical-thinking skills.
- Strong communication, writing, and presentation skills.
- Intermediate knowledge of Microsoft Office or similar software, including Excel, PowerPoint, Word, and Outlook.
- Program management skills.
Nice To Haves
- A degree in life sciences; clinical trial experience is preferred.
Responsibilities
- Lead operational planning, feasibility, and execution of a clinical trial.
- May serve as the clinical trial team lead.
- Lead or contribute to study planning, development, and execution, 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.
- Manage study timelines and lead risk identification, mitigation, and issue resolution.
- 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.
- Lead meetings and processes and influence peers in a matrix environment.
Benefits
- Medical, dental, and vision healthcare benefits.
- Other insurance benefits for employees and their families.
- Retirement benefits, including a 401(k).
- Paid holidays.
- Vacation.
- Compassionate and sick days.
- Annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
