Senior Study Manager

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.

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

Primary responsibilities include:

• Operational planning and project management of epidemiology research studies
• Execution, and close out of primary data collection, chart review, database, and molecular epidemiology studies in addition to other activities
• Manage- vendors including qualification efforts, confidentiality agreements, specifications, and contract reviews
• Assist with review and finalization of all vendor documents such as the safety management, data management, communication, project management and validation plans
• Participate in protocol and interim/final report preparation, shepherd document through the internal review process for approval, and upload to department repository
• Coordination of collection, international shipment, processing by internal/external labs and data transfer for biospecimen- based studies
• Participate in quality control assessments and ensure integrity of study data for reports and publications
• Understand, coordinate, and document adherence to internal, external, and regulatory compliance requirements
• Collaborate extensively and troubleshoot issues by providing potential resolutions when necessary to ensure timely management and execution of studies
• Manage poster and publication development including formatting, medical writing, figure/data content development, co-author review, internal review process, and journal submissions
• Conduct literature reviews
• Active participation in internal process improvement initiatives and mentoring of junior study managers

Education Requirements:

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

Required experience and skills:

• Five (5)+ years of work experience within clinical/observational research or equivalent experience; or PhD with 3+ years relevant career experience
• Excellent communication and interpersonal skills and the ability to collaborate with and influence a wide variety of stakeholders
• Knowledge of epidemiology and/or outcomes research
• Strong project management and prioritization skills
• Highly motivated, able to work independently and collaboratively

Required Skills:
Accountability, Adaptability, Clinical Data, Clinical Operations, Clinical Study Design, Clinical Trial Compliance, Clinical Trial Management, Data Analysis, Deep Learning, Ethical Standards, ICH GCP Guidelines, Machine Learning (ML), Medical Writing, Motivation Management, Regulatory Compliance, Regulatory Documents, 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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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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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

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 .

You can apply for this role through (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:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
No

Job Posting End Date:
03/20/2026
*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: R389417