Principal Clinical Data Manager jobs in United States
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Veristat · 19 hours ago

Principal Clinical Data Manager

Veristat is a global team with over 30 years of expertise in accelerating life-changing therapies to patients worldwide. The Principal Clinical Data Manager is responsible for managing data management tasks for clinical research projects, ensuring data quality, and leading a team of Clinical Data Managers to oversee multiple studies.

Life ScienceMedicalPharmaceutical
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H1B Sponsor Likelynote
Hiring Manager
Steffan Ishan
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Responsibilities

Working independently and in consort with management, the Principal Clinical Data Manager is responsible for the performance of data management tasks from study start-up through database lock for assigned clinical research projects, including paper-based and electronic data capture (EDC) studies, and is responsible for overall data quality and documentation on clinical research projects
The Principal Clinical Data Manager will work on mid-to-large complex projects in various indications, at times serving as program manager, overseeing multiple studies under the same client
S/he will lead a team of CDMs to ensure all the contracted activities are carried out according to the Standard Operating Procedures of Veristat and/or Sponsor specific requirements
In consort with Data Management leadership, the Principal Clinical Data Manager promotes consistent operations, efficient use of resources, and sharing of knowledge and best practices
S/he, in consultation with the managers, will assist with the training of other data managers on project specific and general data management processes, procedures and systems, as well as providing training to other functions across the company as needed

Qualification

Clinical Data ManagementICH GCP GuidelinesClinical Trial DatabasesProject ManagementMedical TerminologyTechnical LeadershipInterpersonal SkillsCommunication SkillsOrganizational Skills

Required

Bachelor's degree in a related field & 7+ years of relevant experience; at least 5 years' experience in clinical data management experience in a clinical research setting and 4 years of experience in leading project teams, required
Thorough knowledge of International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research
Working knowledge of the relationship and regulatory obligation of the contract research organization (CRO) industry with pharmaceutical / biotech companies
Demonstrated ability to lead by example, and demonstrated skill for technical leadership of staff
Demonstrated ability to serve as a strong internal and external consultant, influence without authority, and guide project teams to mutually acceptable outcomes
Demonstrated ability to operate with the “big picture” in mind and serve as a thought partner to management as needed
Expert level skills in use of computer technology, including clinical trial databases and applications (e.g., IBM Clinical Development, Medidata RaveX), with a strong desire and ability to learn new applications
Detailed understanding of project planning and management methods
Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment
Ability to work in different projects with different priorities and act as team mentor, and provide data management expertise

Benefits

Remote working
Flexible time off
Paid holidays
Medical insurance
Tuition reimbursement
Retirement plans

Company

Veristat

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Veristat is a full service Clinical Research Organization (CRO).

H1B Sponsorship

Veristat has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2023 (2)
2022 (5)
2021 (2)
2020 (11)

Funding

Current Stage
Late Stage
Total Funding
unknown
Key Investors
WindRose Health Investors
2021-04-07Private Equity

Leadership Team

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Barbara Balser
Executive Vice President and CSO
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Cindy Henderson
Chief Strategy Officer (CSO)
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Company data provided by crunchbase