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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Hybrid Hybrid work Hybrid work model On-site Puerto Rico residents only US and Puerto Rico residents only
Benefits/PerksAccommodation 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
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
Experience3 - 5 years
EducationAS 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 TimezonesAmerica/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