Sr. Spclst, Project Management
Merck
4 hours ago
Remote friendly (North Wales, PA)
United States
Operations
Responsibilities And Primary Activities:
- Coordinates all aspects of observational/non-interventional research activities, including primary-data collection, chart review/surveys, database studies, health economic model development/adaptations, and other Health Technology Assessment (HTA) support activities.
- Supports scientist(s) with overall operational support for research conduct in compliance with Good Pharmacoepidemiology Practice (GPP), company policies, and SOPs.
- Provides operational support for execution and closeout of primary-data collection, chart review, and database studies (and other activity types).
- Manages several complex activities and study types.
- Liaises with and provides oversight/direction to suppliers; communicates with internal cross-functional teams to share project status and mitigations.
- Tracks timelines/deliverables and follows up on action items (vendors and internal teams/scientists).
- Assists with review/finalization of supplier documents (monitoring, project management, safety management, data management, validation plans).
- Participates in protocol and interim/final report preparation; shepherds documents through internal review/approval and submits to internal repository.
- Coordinates internal/external meeting management and drafts/reviews agendas and minutes.
- Ensures studies follow non-interventional processes: informed consent, compliance, site contract and budget review/approval, protocol review, study registration (when applicable), adverse-event reconciliation, publication submission, and closeout.
- Coordinates confidentiality and consultant agreements and external engagement meetings.
- Participates in quality control and integrity of study data and reports for publications.
- Manages publication development (formatting, figure/data content, co-author review, internal review, journal submissions).
- Collaborates and troubleshoots issues with potential resolutions to ensure timely execution.
- Participates in internal process-improvement initiatives and mentors other research managers.
Required Qualifications/Experience:
- Bachelor’s degree in life sciences or public health (or closely related discipline such as epidemiology, health administration, or biological sciences).
- 3–5+ years of work experience in clinical/observational research (or equivalent).
- Ability to understand, describe, and document observational study procedures/compliance requirements for internal/external stakeholders (e.g., outside investigators/suppliers, key opinion leaders).
- Excellent communication and interpersonal skills; ability to collaborate with diverse stakeholders.
- Basic knowledge of epidemiologic or outcomes research.
- Strong project management and prioritization skills.
- Motivated; able to work independently and collaboratively.
- Solution-oriented, detail-oriented, and timely.
- Ability to manage a high volume of complex research activities.
Preferred Qualifications:
- Master’s degree in life sciences or public health (or related discipline such as epidemiology, health administration, or biological sciences).
Required Skills:
- Adaptability, critical thinking, data analysis, epidemiological research, health economics, Health Technology Assessment (HTA), Real World Evidence (RWE), meeting management, project management, project scheduling, process improvements, regulatory compliance, risk management, safety management, budget development, change/resource allocation.
Benefits (if explicitly stated):
- Eligible for annual bonus and long-term incentive (if applicable); comprehensive benefits including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.
- Coordinates all aspects of observational/non-interventional research activities, including primary-data collection, chart review/surveys, database studies, health economic model development/adaptations, and other Health Technology Assessment (HTA) support activities.
- Supports scientist(s) with overall operational support for research conduct in compliance with Good Pharmacoepidemiology Practice (GPP), company policies, and SOPs.
- Provides operational support for execution and closeout of primary-data collection, chart review, and database studies (and other activity types).
- Manages several complex activities and study types.
- Liaises with and provides oversight/direction to suppliers; communicates with internal cross-functional teams to share project status and mitigations.
- Tracks timelines/deliverables and follows up on action items (vendors and internal teams/scientists).
- Assists with review/finalization of supplier documents (monitoring, project management, safety management, data management, validation plans).
- Participates in protocol and interim/final report preparation; shepherds documents through internal review/approval and submits to internal repository.
- Coordinates internal/external meeting management and drafts/reviews agendas and minutes.
- Ensures studies follow non-interventional processes: informed consent, compliance, site contract and budget review/approval, protocol review, study registration (when applicable), adverse-event reconciliation, publication submission, and closeout.
- Coordinates confidentiality and consultant agreements and external engagement meetings.
- Participates in quality control and integrity of study data and reports for publications.
- Manages publication development (formatting, figure/data content, co-author review, internal review, journal submissions).
- Collaborates and troubleshoots issues with potential resolutions to ensure timely execution.
- Participates in internal process-improvement initiatives and mentors other research managers.
Required Qualifications/Experience:
- Bachelor’s degree in life sciences or public health (or closely related discipline such as epidemiology, health administration, or biological sciences).
- 3–5+ years of work experience in clinical/observational research (or equivalent).
- Ability to understand, describe, and document observational study procedures/compliance requirements for internal/external stakeholders (e.g., outside investigators/suppliers, key opinion leaders).
- Excellent communication and interpersonal skills; ability to collaborate with diverse stakeholders.
- Basic knowledge of epidemiologic or outcomes research.
- Strong project management and prioritization skills.
- Motivated; able to work independently and collaboratively.
- Solution-oriented, detail-oriented, and timely.
- Ability to manage a high volume of complex research activities.
Preferred Qualifications:
- Master’s degree in life sciences or public health (or related discipline such as epidemiology, health administration, or biological sciences).
Required Skills:
- Adaptability, critical thinking, data analysis, epidemiological research, health economics, Health Technology Assessment (HTA), Real World Evidence (RWE), meeting management, project management, project scheduling, process improvements, regulatory compliance, risk management, safety management, budget development, change/resource allocation.
Benefits (if explicitly stated):
- Eligible for annual bonus and long-term incentive (if applicable); comprehensive benefits including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate/sick days.
Application Instructions:
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Application deadline is stated on the posting.