Senior Specialist, Global 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 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.

• 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.

• 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.

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

#eligibleforERP

Accountability, Accountability, Adaptability, Budget Development, Change Management, Collaborative Development, Communication, Critical Thinking, Data Analysis, Epidemiological Research, Health Economics, Health Technology Assessment (HTA), Meeting Management, Outcomes Research, Process Improvements, Project Management, Project Prioritization, Project Schedule, Protocol Review, Public Health, Quality Control Management, Quality Management, Real World Evidence (RWE), Regulatory Compliance, Risk Management {+ 1 more}

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