FreshRemote.Work

Senior Study Manager - Women's cancer

USA - Pennsylvania - North Wales (Upper Gwynedd), United States

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.

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

  • Ability to manage multiple competing priorities with good anning, time management and 

  • prioritization skills

  • Solid understanding of the princi es 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.)

Education/Experience:

  • Bachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience

  • OR Master's Degree +3 year of pharmaceutical, clinical drug development, project management, and/or medical field experience

  • OR PhD/PharmD Degree

  • Degree in life sciences, preferred.

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 have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description …

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Job Profile

Regions

North America

Countries

United States

Restrictions

Hybrid Hybrid work Hybrid work model On-site Puerto Rico residents only US and Puerto Rico residents only

Benefits/Perks

Accommodation support Bonus eligibility Collaboration Diverse workplace Equal opportunity employer Flexible work Flexible work arrangements Health Care Hybrid work Hybrid work model Inclusion Inclusive environment Inclusive workplace Insurance Meetings Paid holidays Retirement benefits Separation benefits package Sick Days Vacation

Tasks
  • Clinical trial execution
  • Collaboration
  • Communication
  • Compliance
  • Conflict resolution
  • Data Management
  • Execution
  • Feasibility
  • Innovation
  • Issue resolution
  • Leadership
  • Lead team
  • Planning
  • Presentation
  • Prioritization
  • Problem solving
  • Project management
  • Project planning
  • Risk Identification
  • Risk Management
  • Stakeholder collaboration
  • Team Leadership
Skills

Analytical Clinical Clinical drug development Clinical Research Clinical trials Collaboration Communication Compliance Conflict Resolution Critical thinking Data Data Management Development Drug Development Education Excel Execution GCP ICH Inclusion Influence Influencing Innovation Issue Resolution Leadership Life sciences Management Manufacturing Matrix Environment Medical Medical field Microsoft Office Operational Organization Outlook Pharmaceutical PharmD PhD Planning Policy PowerPoint Presentation Prioritization Project Management Project Planning Regulatory Regulatory requirements Research Risk Identification Talent Acquisition Teams Technical Timeline Management Time Management Word Writing

Experience

3 - 5 years

Education

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

Certifications

Microsoft

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