Associate Director, Study Manager - Atherosclerosis and Metabolism

Merck•Rahway, NJ

4d•$142,400 - $224,100

About The Position

This position participates in strategy and leads the operational planning and execution of one or more clinical trials. As part of a global, cross-functional team, the Study Manager demonstrates advanced leadership and technical skills and builds and coaches team members 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 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.
Proactive approach, strategic thinking, and leadership in working with stakeholders across the department, division, and company to achieve study goals.
Demonstrated leadership in programs and processes, including leading meetings and influencing peers and direct or indirect reports in a matrix environment.
Problem-solving, prioritization, conflict-resolution, and critical-thinking skills.
Strong communication, writing, and presentation skills.
Proficient knowledge of Microsoft Office or similar applications, 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

Degree in life sciences.
Preferred skills include process improvement, program management, and project management.

Responsibilities

Oversee operational planning, feasibility, execution, and conduct of 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, senior management presentations, program-level cross-functional meetings, and governance.
Facilitate collaboration 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 relevant clinical documents, including protocols, and provide clinical operations input.
May 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 assignment, professional development, and performance management.