Senior Study Manager, Immunology

MSD Malaysia; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Medical, dental, vision

Job summary

Merck in Rahway, NJ seeks a Clinical Operations Lead to orchestrate the planning and execution of one or more clinical trials within the Tulisokibart program. The role requires expertise in study planning, country/site selection, and cross-functional collaboration to meet timelines and deliverables.

The ideal candidate demonstrates strong project management, leadership, and problem-solving skills, with solid knowledge of GCP/ICH regulatory requirements and excellent communication capabilities.

Qualifications

• Experience driving operational activities on clinical protocols.
• Solid knowledge of clinical research regulatory requirements (GCP/ICH).
• Ability to manage multiple priorities with planning and prioritization.
• Strong written and verbal communication skills.

Responsibilities

• Lead operational planning and execution of one or more clinical trials.
• Coordinate data management deliverables, timelines, and site selection.
• Collaborate with internal/external stakeholders to meet study objectives.
• Manage vendors and study partners to ensure milestones are met.
• Provide leadership in meetings and drive study goals in a matrix environment.

Skills

Clinical operations

Regulatory knowledge (GCP/ICH)

Project planning

Timeline management

Stakeholder management

Problem solving

Communication

Leadership

Team coordination

Microsoft Office

Education

Tools

MS Office

Job description

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

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.)

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 clinicaltrialjobs 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

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. Please click here if you need an accommodation during the application or hiring process. 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 We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts 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. 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. The application deadline for this position is stated on this posting. 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

Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 09/24/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.