Senior Specialist, Project Management

Role Overview

• 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)
• 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

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