Senior Study Manager, Immunology

Merck & Co.

Rahway (NJ)

On-site

USD 117,000 - 184,000

Full time

3 days ago

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Benefits offered by this job

Medical benefits

401(k) retirement plan

Paid holidays

Job summary

Merck & Co. is seeking a skilled Clinical Operations leader to oversee the planning and execution of one or more clinical trials within our global programs.

You will lead cross-functional teams, manage timelines, and drive strategic initiatives to ensure study success across sites and vendors. The role requires strong project management, regulatory knowledge, and leadership abilities to coordinate with study teams, country offices, and external partners.

Qualifications

Bachelor's degree or higher with 5+ years in pharma/clinical development or PM.
Master's degree with 3+ years in related field.
PhD/PharmD degree accepted.
Life sciences degree preferred.

Responsibilities

Responsible for operational planning, feasibility, and execution of a clinical trial.
May serve as the clinical trial team lead and oversee study planning and execution elements.
Lead timelines, risk management, issue resolution and stakeholder collaboration.
Coordinate with internal and external stakeholders to support trial objectives.
Accountable for managing study partners and vendors.
Drive communications plans, status reports, and study close-out activities.

Skills

Clinical Operations

Project Management

GCP Compliance

Regulatory Understanding

Stakeholder Management

Leadership

Communication

Strategic Thinking

Problem Solving

Time Management

Data Analysis

Clinical Development

Education

Bachelor's degree in life sciences

Master's degree in life sciences

PhD/PharmD

Degree in life sciences preferred

Tools

Microsoft Office

Data Management Tools

Job description

This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof in our Tulisokibart program. 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

Core Skills

Demonstrated ability to drive and manage operational activities on clinical protocols. This position may represent the company through external partnerships, collaborations, and key strategic engagements. This includes the ability to:
Solid knowledge of clinical research regulatory requirements (e.g., Good Clinical Practice (GCP) and International Council for Harmonisation (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-
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 and 5+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience -OR-
Master's Degree and 3+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience -OR-
PhD/PharmD Degree
Degree in life sciences, preferred

Ideal candidate would have:

Experience in conducting global clinical trials, including trial initiation through database lock
Highly Preferred: experience in conducting clinical trials for Gastroenterology, Dermatology or Rheumatology, especially autoimmune or immune‑mediated disorders
Experience in managing and driving operational activities on protocols for immunology related clinical trials

Required Skills:

Adaptability
Analytical Problem Solving
Clinical Development
Clinical Operations
Clinical Sciences
Conflict Management
Critical Thinking
Ethical Standards
Good Clinical Practice (GCP)
Partner Relationship Management (PRM)
People Management
Presentation Delivery
Process Improvements
Stakeholder Alignment
Strategic Thinking

Preferred Skills:

Leadership
Prioritization
Problem Solving
Study Management

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights

EEOC GINA Supplement

Learn more about your rights, including under California, Colorado and other US State Acts

San Francisco Residents Only:

We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

The salary range for this role is

$117,000.00 - $184,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits .

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License: