Senior Study Manager, Epidemiology Operations

Job Description

Support the Lead Epi Scientists by providing overall operational support for study conduct. Responsible for the coordination and execution of observational or non-interventional research studies (including Post Authorization studies), in compliance with Good Pharmacoepidemiology Practice (GPP) and Standard Operating Procedures (SOPs). Manages several complex activities and study types.

Primary responsibilities include

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Operational planning and project management of epidemiology research studies

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Execution, and close out of primary data collection, chart review, database, and molecular epidemiology studies in addition to other activities

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Manage vendors including qualification efforts, confidentiality agreements, specifications, and contract reviews

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Assist with review and finalization of all vendor documents such as the safety management, data management, communication, project management and validation plans

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Participate in protocol and interim/final report preparation, shepherd document through the internal review process for approval, and upload to department repository

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Coordination of collection, international shipment, processing by internal/external labs and data transfer for biospecimen- based studies

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Participate in quality control assessments and ensure integrity of study data for reports and publications

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Understand, coordinate, and document adherence to internal, external, and regulatory compliance requirements

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Collaborate extensively and troubleshoot issues by providing potential resolutions when necessary to ensure timely management and execution of studies

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Manage poster and publication development including: formatting, medical writing, figure/data content development, co-author review, internal review process, and journal submissions

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Conduct literature reviews

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Active participation in internal process improvement initiatives and mentoring of junior study managers

Educational Requirments

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Bachelor's degree required / Master's degree (preferred) in public health (or closely related discipline, such as biostatistics, epidemiology, health administration or biological sciences)

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Five (5)+ years of work experience within clinical/observational research or equivalent experience; or

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PhD with 3+ years relevant career experience

Required experience and skills

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Excellent communication and interpersonal skills and the ability to collaborate with and influence a wide variety of stakeholders

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Knowledge of epidemiology and/or outcomes research

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Strong project management and prioritization skills

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Highly motivated, able to work independently and collaboratively

Required Skills

Clinical Data, Clinical Operations, Clinical Study Design, Clinical Trial Compliance, Clinical Trial Management, Data Analysis, Epidemiology, Ethical Standards, ICH GCP Guidelines, Project Prioritization, Public Health, Regulatory Compliance, Regulatory Documents, Safety Management, Scientific Publications

Preferred Skills

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

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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 .

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

No relocation

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

N/A

Job Posting End Date

06/25/2026

*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.

Requisition ID: R403480