Associate Director Study Manager (Hybrid)

Job Description

Role Overview: The Associate Director Study Manager leads the operational planning, execution, and delivery of one or more global clinical trials. This role is accountable for ensuring high-quality study conduct, driving timelines, managing risks, and coordinating across internal and external stakeholders to meet clinical trial objectives.

Key Responsibilities:

• Lead operational planning, feasibility assessment, and execution of assigned clinical trials(s)

• Serve as the Clinical Trial Team (CTT) Lead and provide cross-functional leadership

• Drive study strategy, operational reviews, and risk identification and mitigation planning

• Collaborate with internal teams, country organizations, and external partners (e.g. CROs, vendors) to deliver study objectives

• Oversee study timelines, key deliverables, and execution milestones

• Provide operational input into clinical trial documents (protocols, plans, reports)

• Lead governance interactions, including senior management updates and cross-functional meetings

• Build team capabilities through coaching, mentoring, and development of junior staff

• Contribute to process improvements and may serve as a subject matter expert

Required Qualifications

Education:

• Bachelor's degree in life sciences or related field required

• Advanced degree preferred

Experience:

• Bachelor's with a minimum of 9 years OR

• Master's with a minimum of 6 years OR

• PhD/PharmD with a minimum of 2 years of clinical development experience

Required Skills:

• Strong Knowledge of ICH/GCP and clinical research regulatory requirements

• Proven ability to lead global, cross-functional clinical trial teams

• Strong project management, planning, and execution skills

• Ability to manage competing priorities and drive milestone delivery

• Advanced problem-solving and risk managementcapabilities

• Strong Stakeholder engagement and influencing skills

• Excellent written and verbal communication skills

• Proficiency in Microsoft Office tools (Excel, PowerPoint, Word)

Preferred Skills:

• Experience working in global clinical trial environments

• Vendor/CRO oversight experience

• Experience in Immunology or relevant therapeutic area

• Experience leading cross-functional governance and decision-making forums

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Required Skills:

Analytical Problem Solving, Clinical Data Management, Clinical Development, Clinical Immunology, Clinical Operations, Clinical Study Design, Clinical Study Management, Clinical Trial Documentation, Clinical Trials, Clinical Trials Operations, Data Analysis, Ethical Standards, Good Clinical Practice (GCP), Health Literacy, Identifying Risks, Life Science, Medical Writing, Operational Performance Management (PM), Operations Support, People Management, Stakeholder Management

Preferred Skills:

Metrics Management, Problem Solving

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US and Puerto Rico Residents Only:

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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:

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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.

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The salary range for this role is

$142,400.00 - $224,100.00

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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). 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

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

07/4/2026

*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.