FreshRemote.Work

Senior Study Manager - General Medicine

USA - New Jersey - Rahway

Job Description

Job Summary:
This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the opportunity to 
demonstrate your leadership and technical skills as part of a global, cross-functional team. You will apply project management, communication, and collaboration skills in 
support of our clinical trials.

Job Responsibilities:
• Responsible for the operational planning, feasibility, and execution of a clinical trial.
• May serve as the clinical trial team lead
• May lead team in key study planning, development, and execution elements (e.g., data management deliverables, trial level plans/timelines, country/site selection, site materials, system updates, investigator meeting planning, communication plans, preparation of status update reports, study close out activities).
• Leads team for timeline management, risk identification and mitigation, issue resolution.
• May facilitate and collaborate with key internal/external stakeholders (e.g., study team, country teams, vendors, committees) in support of clinical study objectives.
• Accountable for managing any study specific partners and/or vendors.

Minimum education required:

Bachelor’s degree + 5 years OR Master’s + 3 years Pharmaceutical and/or clinical drug development experience OR PhD/PharmD Degree in life sciences, preferred.

Required experience and skills:

  • Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH).

  • Ability to manage multiple competing priorities with good planning, time management and prioritization skills.

  • Solid understanding of the principles of project planning & project management.

  • Good analytical skills to drive operational milestones.

  • Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division.

  • Interact with key stakeholders across department, division, and company.

  • Role requires a proactive approach and leadership driving toward study goals.

  • Applying leadership skills to 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 in Microsoft office or similar (Excel, PowerPoint, Word, Outlook, etc.).

Preferred experience and skills:

A plus with prior experience on managing global pediatric clinical trials (age 6 +), including managing central lab and overseeing PK sample tracking and managements (with central lab).

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but …

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Job Profile

Regions

North America

Countries

United States

Benefits/Perks

Flexible work arrangements

Skills

Clinical Research Clinical trials Collaboration Communication Critical thinking Data Management Excel GCP Innovation Leadership Microsoft Office Problem-solving Project Management Regulatory Compliance Technical

Tasks
  • Issue resolution
  • Lead team in study planning and execution elements
  • Manage study specific partners and vendors
  • Operational planning and execution of clinical trials
Experience

3 years

Education

Bachelor's degree Business Degree in life sciences Life Sciences Master's degree Pharm.D Ph.D.

Restrictions

Hybrid Hybrid work model

Timezones

America/Anchorage America/Chicago America/Denver America/Los_Angeles America/New_York Pacific/Honolulu UTC-10 UTC-5 UTC-6 UTC-7 UTC-8 UTC-9