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) Education Preferred: 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 mana