
Senior Specialist, Global Research Manager
MSD
full-time
Posted on:
Location Type: Hybrid
Location: North Wales • New Jersey • Pennsylvania • United States
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Salary
💰 $106,200 - $167,200 per year
Job Level
About the role
- 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.
Requirements
- Minimum Bachelor's degree in life sciences or public health (or closely related discipline, such as epidemiology, health administration, or biological sciences).
- A minimum of three 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.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
primary-data collectionchart reviewdatabase studieshealth economic model developmentGood Pharmacoepidemiology Practicestandard operating proceduresprotocol preparationpublication developmentquality controldata management
Soft Skills
communication skillsinterpersonal skillsproject managementprioritization skillssolution-orienteddetail-orientedtimelycollaborationmentoringindependent work