Sr. Spclst, Project Management

Job Description

Role Summary

• The Senior Specialist, Research Manager, position resides in the Value & Implementation (V&I) organization, which includes Global Medical and Scientific Affairs as well as Outcomes Research.

• The Non-Interventional Research Management team provides support across all elements of management and execution of non-interventional studies and research activities.

• This position, under the supervision of an Associate Director or above, will execute a variety of research management activities from study execution to closeout and summarization of results from observational-research activities. Research managers are aligned by department/therapeutic area (TA) for activities under V&I Plans.

Responsibilities and Primary Activities

• Coordinates all aspects of observational or non-interventional research activities, which includes the implementation of primary-data collection, chart review/survey, and database studies; health economic model development and adaptations; and other activities in support of Health Technology Assessment (HTA).

• Supports scientist(s) by providing overall operational support for research conduct in compliance with Good Pharmacoepidemiology Practice (GPP), company policies, and standard operating procedures (SOPs).

• Provides operational support of observation or non-interventional research activities, including execution and closeout of primary-data collection, chart review, and database studies in addition to other activity types.

• Manages several complex activities and study types.

• Liaises with and provides oversight/direction to supplier and communicates with internal cross-functional teams to share project status and mitigations.

• Tracks timelines/deliverables and follows up on action items (vendor and internal teams/scientists).

• Assists with review and finalization of all supplier documents, such as monitoring, project management, safety management, data management, and validation plans.

• Participates in protocol and interim/final report preparation, shepherds documents through the internal review process for approval, and submits to the internal repository.

• Coordinates internal/external meeting management and drafts/reviews agendas and minutes.

• Ensures that studies follow all non-interventional processes for informed consent, compliance, site contract and budget review/approval, protocol document review, study registration (when applicable), adverse-event reconciliation, publication submission, and closeout.

• Coordinates confidentiality and consultant agreements, as well as external engagement meetings.

• Participates in quality control and integrity of study data and reports for publications.

• Manages publication development, including formatting, figure/data content development, co-author review, internal review process, and journal submissions.

• Collaborates and troubleshoots issues by providing potential resolutions when necessary to ensure timely management and execution of activities.

• Participates in internal process-improvement initiatives with Research Management and mentors other research managers as necessary.

 

Required Qualifications, Skills and Experience

Minimum

• Bachelor's degree in life sciences or public health (or closely related discipline, such as epidemiology, health administration, or biological sciences).

• At least three to five years of work experience within clinical/observational research or equivalent.

• Ability to understand, describe and document (when applicable) procedures/compliance requirements for observational studies to internal and external stakeholders such as outside investigators/suppliers and key opinion leaders.

• Excellent communication and interpersonal skills; ability to collaborate with a wide variety of stakeholders.

• Basic knowledge of epidemiologic or outcomes research.

• Strong project management and prioritization skills.

• Motivation and ability to work independently and collaboratively.

• Proven ability to be solution-oriented, detail-oriented and timely.

• Ability to manage a high volume of complex research activities.

Preferred

• Master's degree in life sciences or public health (or related discipline such as epidemiology, health administration, or biological sciences).

Required Skills:

Adaptability, Adaptability, Biological Sciences, Budget Development, Change Management, Collaborative Development, Critical Thinking, Data Analysis, Epidemiological Research, Health Economics, Health Technology Assessment (HTA), Life Science, Meeting Management, Prioritization, Process Improvements, Project Management, Project Schedule, Public Health, Quality Control Management, Quality Management, Real World Evidence (RWE), Regulatory Compliance, Resource Allocation, Risk Management, Safety Management {+ 1 more}

Preferred Skills:

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Current Contingent Workers apply HERE

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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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

$106,200.00 - $167,200.00

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:

04/29/2026

*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.