Senior Specialist, Research Manager

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 Senior Specialist serves as a key cross-functional coordinator, partnering with Real-World Data Analytics & Innovation (RDAI), Outcomes Research, and/or internal and external stakeholders to ensure successful study execution. This position, under the supervision of an Associate Director or above, will execute a variety of study operations, facilitate collaboration across teams, track milestones and deliverables, and support the delivery of protocols, publications, and compliance requirements throughout the study lifecycle. Research managers will be aligned by department/Therapeutic Area for activities under Value & Implementation (V&I) Plans.

Primary responsibilities include:

• Coordinates all aspects of observational or non-interventional research activities.

• 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 a variety of complex activities and study types.

• Track timelines/deliverables and follow up on action items.

• Maintain key study information in applicable system(s) and manage budget, including adherence to invoice and payment schedule.

• Assist with review and finalization of study related documents such as monitoring, project management, safety management, data management and validation plans.

• Participate in protocol and interim/final report preparation, shepherd documents through the internal review process for approval, and submit to the internal repository.

• Coordinate internal/external meeting management and draft/review agenda/minutes.

• Ensure studies follow all non-interventional processes for informed consent, compliance, training, site contract and budget review/approval, protocol document review (including DRC), study registration (when applicable), adverse event reconciliation, change orders, publication submission, and study close out.

• 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.

• Coordinate confidentiality, consultant agreements and external engagement meetings.

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

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

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

• May participate in internal process improvement initiatives with Research Management and mentoring of other Research Managers.

Qualifications:

Education Required:

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

EducationPreferred:

• Master’s degree in life sciences or public health

• PMP or CAPM certification

• Therapeutic area background in oncology, vaccines, infectious disease, immunology, diabetes, or cardiology

Experience and Skills:

Required:

• Three or more years of work experience within clinical/observational research or equivalent

• Excellent communication and interpersonal skills; ability to collaborate with a wide variety of stakeholders in medical or scientific teams

• Basic knowledge of epidemiologic, outcomes research, or health economic modeling

• Strong project management and prioritization skills; resourcefulness

• Highly motivated, able to work independently and collaboratively

• Solution-oriented, timely and detailed-oriented

• Ability to manage higher volume/complexity of research activities; flexibility

• Proficiency in Microsoft Office suite (Outlook, Word, Excel, PowerPoint, Teams, etc.)

Preferred:

• Prior experience leading large complex multi-stakeholder projects

• Prior cross-functional study management and budget-planning experience

• Working knowledge of Veeva Vault and iEnvision platforms and applications

Required Skills:

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. Asa 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

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*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.