Senior Study Manager - Womens cancer

$111,400 - $175,300/Yr

Merck KGaA Darmstadt Germany - North Wales, PA

Full-time - Mid Level

Onsite - North Wales, PA

Chemical Manufacturing

About the position

The Senior Study Manager for Women's Cancer is responsible for leading the operational planning and execution of clinical trials. This role involves demonstrating leadership and technical skills within a global, cross-functional team, applying project management, communication, and collaboration skills to support clinical trials effectively.

Responsibilities

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

Requirements

• Bachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR Master's Degree +3 years of experience OR PhD/PharmD Degree.
• Degree in life sciences preferred.
• Solid knowledge of clinical research regulatory requirements (e.g., Google Cloud Platform 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.
• Strong communication, writing, and presentation skills.
• Intermediate knowledge in Microsoft Office or similar (Excel, PowerPoint, Word, Outlook, etc.).

Benefits

• Bonus eligibility
• Long term incentive if applicable
• Health care and other insurance benefits (for employee and family)
• Retirement benefits
• Paid holidays
• Vacation
• Sick days