Clinical Data Manager

We are currently searching for a Clinical Data Manager to provide support to the National Institutes of Health (NIH). This opportunity is a full-time position with MSC, and it is on-site in Rockville, MD

• Oversee sponsor Clinical Data Management activities for the adaptive platform trial, ACTIV-2.
• Work collaboratively across multiple cross functional groups including Clinical Trial Managers (CTM’s), Biostatistics and Clinical Data Management vendors to ensure database development, data review/cleaning, database auditing, database lock, and receipt of final database deliverables are in compliance with standard operating procedures and regulatory agency guidelines.
• Provide technical oversight of service providers performing core data management functions including CRF/edit check development, user acceptance testing (UAT), integrated response technology (IRT), biostatistics, data cleaning, listings review, and database lock procedures.
• Responsible for the oversight of clinical data management study deliverables, evaluates and mitigates data management-related risks across functional areas of ACTIV-2 on behalf of the trial sponsor.
• Conduct reviews of oversight related data, operations-related trend analyses, and performs report reviews.
• Review the development of database specifications, validation plans, and data management plans, ensuring alignment with case report forms, protocol, and safety data standards.
• Responsible for overseeing the end-to-end data management study related activities in terms of quality and delivery according to plan on a day-to-day basis.
• Provide oversight for data management activities, including: Implementation of data management aspects of ACTIV-2 and data collection systems; Strategic input into mitigation of potential data management issues; Review data management activities and recommend process improvements; Maintain high-level oversight on data quality metrics and data management deliverables.

#LI-DD1

• Master’s Degree in clinical, biological, mathematical or computer science subject.
• Minimum ten (10) years of experience in clinical data management.
• Experience with developing and managing clinical trial databases and data management/collection systems.
• Familiarity with user testing, integrated response technology (IRT), and biostatistics useful.
• Experience with extensive data reporting, data specifications, validations and data planning.
• Project management experience or experience managing timelines highly desired.
• Strong verbal and written communication skills.

Due to our contractual requirements, to be eligible for this role, you must be fully vaccinated against COVID-19 at time of hire.  

Dovel Technologies and its Family of Companies (Medical Science & Computing and Ace Info Solutions) were acquired in October 2021.

Guidehouse is a leading global provider of consulting services to the public sector and commercial markets, with broad capabilities in management, technology, and risk consulting. By combining our public and private sector expertise, we help clients address their most complex challenges and navigate significant regulatory pressures focusing on transformational change, business resiliency, and technology-driven innovation. Across a range of advisory, consulting, outsourcing, and digital services, we create scalable, innovative solutions that help our clients outwit complexity and position them for future growth and success. The company has more than 12,000 professionals in over 50 locations globally. Guidehouse is a Veritas Capital portfolio company, led by seasoned professionals with proven and diverse expertise in traditional and emerging technologies, markets, and agenda-setting issues driving national and global economies.

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