Overview

Principal Data Manager

US Remote

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee - from entry level through top executive - to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

The Principal Data Manager provides data management leadership and subject matter expertise for research studies. The Principal Data Manager works as an integral part of a cross-functional team through the lifecycle of the research study from design through final analysis and study closeout. The Principal Data Manager is responsible for the completeness and accuracy of the study data in the electronic database and serves as an expert consultant to cross-functional internal and external teams on all aspects of data collection and data management best practices.

Responsibilities

• Serves as lead point of contact for both internal cross-functional teams and external contacts on the design, documentation, testing, and implementation of clinical data collection studies in an electronic data capture (EDC) system
• Provides oversight for creation and/or review of study-specific electronic or paper Case Report Forms (CRFs) using strong technical knowledge, protocol-specific information, and departmental standards; ensures timely development and implementation of CRFs; serves as project or therapeutic area resource for design and development challenges
• Provides oversight for determining data collection requirements at a project or therapeutic area level, utilizing extensive experience to drive development
• Responsible for analyzing potential complex data management issues/risks and recommending/implementing solutions
• Approves/reviews clinical data management plans or develops key study document templates (e.g. Data Management Handbook, Data Management Plan, Data Validation Plan, EDC System User's Guide, EDC Training and Certification Documents)
• Leads data reviews with data management team to ensure accuracy and consistency and creates corrective action plan as necessary
• Provides oversight of training documentation and system user access; may serve as resource for complex troubleshooting
• Mentors DM staff in general team leadership skills, project management skills, internal Emmes DM processes, and for project or therapeutic area specific tasks
• Authors, reviews, and/or edits written summaries of data reports; presents data as applicable
• Provides oversight for the management and reconciliation processes of the data obtained through Electronic Medical Records (EMR) integration, commercially available EDC systems, or other external data sources
• May be required to facilitate or present at meetings, conferences, and other events representing Emmes, including job fairs or other external events
• Develops and implements data validation processes; ensures the integrity of data, providing recommendations for correction action when necessary
• May provide direct line support for DM staff. For direct reports:
  o Collaboratively conducts performance and compensation review activities with the applicable project leader or designee
  o Responsible for addressing employee relations issues and resolving problems
  o Ensures DM salary and bonus equity compliance
  o Approves timesheets, expense reports, and leave requests
• Other duties as assigned

Qualifications

• Bachelor's degree, preferably in a public health, clinical, science, technical, or related discipline; equivalent combination of education and relevant work experience may be considered in lieu of a degree
• Incumbent typically will possess at least 8 years of progressive data management experience (or Master's degree with 6 years) and strong understanding of clinical research and/or data management processes
• Ophthalmology experience, with a focus on gene therapy studies is preferred.
• Knowledge of GCP and applicable regulatory guidelines
• Experience in pharmaceutical industry and/or contract research organization preferred
• Experience in clinical electronic data capture (EDC) systems preferred
• Knowledge of Microsoft Office suite is essential
• Good analytical, interpersonal, and organizational skills
• Excellent verbal and written communication skills with ability to inform and collaborate
• Must have a good understanding of clinical database structures and data management processes
• Strong attention to detail, adaptable, and flexible
• Self-motivated and proactive with demonstrated ability to work independently

Emmes requires all US based Clinical Research Associate new hires to be fully vaccinated before their first day of employment. All new hires may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. Emmes complies with all applicable laws regarding reasonable accommodations or exemptions for religious, medical, or other legally protected reasons.

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Unlimited Approved Leave

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.