Senior Study Manager, Oncology

$111,400 - $175,300/Yr

Merck & Co. - Rahway, NJ

Full-time - Mid Level

Onsite - Rahway, NJ

Chemical Manufacturing

About the position

The Senior Study Manager, Oncology position is a pivotal role that leads the operational planning and execution of one or more clinical trials or significant aspects of them. This position offers an opportunity to demonstrate leadership and technical skills as part of a global, cross-functional team. The successful candidate will utilize project management, communication, and collaboration skills to support clinical trials effectively. The role requires a proactive approach to managing timelines, identifying risks, and resolving issues, ensuring that the study objectives are met efficiently. In this role, the Senior Study Manager will be responsible for the operational planning, feasibility, and execution of clinical trials. They may serve as the clinical trial team lead and will lead the team in key study planning, development, and execution elements. This includes managing data management deliverables, trial level plans and timelines, country and site selection, site materials, system updates, investigator meeting planning, communication plans, preparation of status update reports, and study close-out activities. The Senior Study Manager will also facilitate collaboration with key internal and external stakeholders, including study teams, country teams, vendors, and committees, to support clinical study objectives. The position requires solid knowledge of clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Council for Harmonisation (ICH) guidelines. The candidate must possess the ability to manage multiple competing priorities, demonstrating excellent planning, time management, and prioritization skills. Strong analytical skills are essential to drive operational milestones, and the ability to influence opinions and decisions across functional areas is crucial. The role also demands strong communication, writing, and presentation skills, along with intermediate knowledge of Microsoft Office or similar tools.

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.
• Lead team for 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 with 5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience, OR
• Master's Degree with 3 years of pharmaceutical, clinical drug development, project management, and/or medical field experience, OR
• PhD/PharmD Degree in a relevant field, preferably in life sciences.
• 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 and project management.
• Good analytical skills to drive operational milestones.
• Strong communication, writing, and presentation skills.

Nice-to-haves

• Experience in oncology clinical trials.
• Familiarity with electronic data capture systems.
• Knowledge of vendor management and oversight.

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