Associate Director, Study Manager - Atherosclerosis and Metabolism

MSD • Rahway, NJ

10d • $142,400 - $224,100

About The Position

The Associate Director, Study Manager participates in strategy and leads the operational planning and execution of one or more clinical trials. The role provides an opportunity to demonstrate advanced leadership and technical skills as part of a global, cross-functional team. The Study Manager builds and coaches the team in project management, communication, and collaboration skills in support of clinical trials.

Requirements

• Bachelor’s degree and 9 or more years of pharmaceutical, clinical drug development, project management, and/or medical field experience; or a master’s degree and 6 or more years; or a PhD/PharmD degree and 2 or more years.
• Strong knowledge of clinical research regulatory requirements, such as Good Clinical Practice (GCP) and International Council for Harmonisation (ICH).
• Ability to manage competing priorities, delegate effectively, and assign activities to meet business needs.
• Ability to develop realistic and effective short- and mid-range project plans.
• Strong analytical skills to drive operational milestones.
• Ability to influence opinions and decisions of internal and external customers and vendors across functional areas and within the division.
• Ability to interact with stakeholders across the department, division, and company, using proactive approaches, strategic thinking, and leadership to drive study goals.
• Demonstrated leadership in programs and processes, including leading meetings and influencing peers and direct and indirect reports in a matrix environment.
• Problem-solving, prioritization, conflict-resolution, and critical-thinking skills.
• Strong communication, writing, and presentation skills.
• Proficiency with Microsoft Office or similar tools, including Excel, PowerPoint, Word, and Outlook.
• Required skills include adaptability, analytical problem solving, clinical data management, clinical study management, collaboration, attention to detail, ethical standards, GCP, stakeholder alignment, and strategic thinking.

Nice To Haves

• A degree in life sciences is preferred.
• Preferred skills include process improvement, program management, and project management.

Responsibilities

• Lead operational planning, feasibility, execution, and conduct of one or more clinical trials.
• Serve as the Clinical Trial Team (CTT) lead.
• Lead and direct teams in study planning, development, and execution, including operational reviews, issue escalation and mitigation, presentations at senior management meetings, program-level cross-functional meetings, and governance.
• Facilitate and collaborate with internal and external stakeholders, including study teams, subsidiary country teams, vendors, and committees, to support clinical trial objectives.
• Liaise with partners, vendors, and the vendor management team.
• Review clinical documents, including protocols, and provide clinical operations input as appropriate.
• Serve as a subject matter expert and/or participate on process improvement teams.
• Build junior team members’ capabilities through coaching, mentoring, and development opportunities.
• May manage direct or indirect reports, including resource assignments, professional development, and performance management.

Benefits

• Medical, dental, and vision healthcare and other insurance benefits for employees and families.
• Retirement benefits, including a 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Eligible for an annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Director