Observational Research Programs Lead

Merck & Co.; Philadelphia (Philadelphia County); Hybrid; USD 106,000 - 167,000; Full time

Job summary

Merck & Co. is seeking a Senior Specialist, Research Manager to coordinate observational/non-interventional studies within the Value & Implementation organization.

You will partner with Real-World Data Analytics & Innovation, Outcomes Research, and internal/external stakeholders to ensure successful study execution and deliverables throughout the lifecycle. Education requires a life sciences/public health background; 3+ years in clinical/observational research is expected.

Qualifications

• 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 management and prioritization skills; resourcefulness
• Highly motivated, able to work independently and collaboratively
• Solution-oriented, timely and detailed-oriented
• Ability to manage higher volume/complexity of research activities; flexibility
• Proficiency in Microsoft Office suite (Outlook, Word, Excel, PowerPoint, Teams, etc.)

Responsibilities

• Coordinates all aspects of observational or non-interventional research activities.
• Supports scientist(s) by providing operational support for research conduct in compliance with GPP, SOPs and company policies.
• Provides operational support of observation or non-interventional research activities, including data collection, chart review, and database studies.
• Manages a variety of complex activities and study types.
• Tracks timelines/deliverables and follows up on action items.
• Maintains key study information in applicable systems and manages budget and invoicing.
• Assists with review and finalization of study documents such as monitoring, PM, safety, data management and validation plans.
• Participates in protocol and interim/final report preparation and submits to internal repository.
• Coordinates internal/external meeting management and drafts agendas/minutes.
• Ensures studies follow non-interventional processes for consent, compliance, contracts, budgets, and publication submissions.
• Describe procedures/compliance requirements for observational studies to stakeholders.
• Coordinates confidentiality, consultant agreements and external engagement meetings.
• Participates in QA and integrity of study data and reports for publications.
• Manages publication development including formatting, figures/tables, co-author review, and journal submissions.
• Collaborates and troubleshoot issues to ensure timely management and execution of activities.
• May participate in process improvements and mentoring of other Research Managers.

Skills

Data Analytics

Meeting Management

Observational Research

Project Management

Real World Data

Real World Evidence

Research Administration

Research Management

Problem Identification

Education

Bachelor's degree in life sciences or public health

Master's degree in life sciences or public health

PMP or CAPM certification

Tools

Veeva Vault

iEnvision

Job description

Merck & Co. is seeking a Senior Specialist, Research Manager to coordinate observational/non-interventional studies within the Value & Implementation organization.

You will partner with Real-World Data Analytics & Innovation, Outcomes Research, and internal/external stakeholders to ensure successful study execution and deliverables throughout the lifecycle. Education requires a life sciences/public health background; 3+ years in clinical/observational research is expected.