Here’s What You’ll Do:

　　 Collaborate with Clinical Development, Data Management and Digital, to implement new central data monitoring technologies to be utilized in support of clinical data management systems

　　 Develop, program, test and maintain TSDV Specifications for study builds and post-production changes (Medidata RAVE)

　　 Support RSR implementation from a data management perspective to support the RBQM strategy according to standards

　　 Support programming and maintenance of clinical data oversight metrics including KRIs and QTLs within Medidata (DETECT) and other technologies utilizing company standards.

　　 Implement and train study teams on standard processes across therapeutic areas for central data monitoring oversight.

　　 Maintain standard libraries associated with central data monitoring activities (Metrics, TSDV Specifications, critical data, etc.)

　　 Support data managers with creation of internal data mapping specifications for central monitoring activities and maintain standard specifications.

　　 Participate in meetings to build central monitoring smart listings and adhere to standards

　　 Managing project priorities and timelines with respect to provision of technology and central data monitoring solutions

　　 Represent the Central Data Monitoring function across Therapeutic Areas or programs and ensures aligned expectations between external CRO partners and central data monitoring activities including study metrics

　　 Support and participate in reviewing CRO partner Central Data Monitoring activities and findings.

　　 Coordinate and manage follow up to central data management findings as appropriate.

　　 Review central monitoring plans to ensure consistency and adherence to standards and the central data monitoring strategy for the studies.

　　 Perform central data monitoring oversight review utilizing technologies (i.e. Medidata DETECT, PerkinElmer Spotfire, Looker Listings, Tableau Listings, etc.)

　　 Ensures achievement of central data monitoring deliverables and milestones in coordination with cross functional team members including: Clinical Operations, Clinical Development, Biostatistics & Programming, Biomarker Operations & Sample Management and Pharmacovigilance in accordance with the data collection requirements as defined in the clinical protocol, in alignment with industry best practice guidelines and enforcement of data standards and processes

　　 Author data management documentation related to central data management technology and review practices

　　Here’s What You’ll Bring to the Table:

　　 BS/BA degree or equivalent in a relevant scientific discipline with 5+ years related Clinical experience

　　 Advanced knowledge of clinical database design and programming is a must (Rave TSDV, Inform, Oracle Clinical or other systems). Safety Gateway,

　　 Good communication skills; ability to work in a team environment with data managers, medical personnel, clinical monitors, statisticians, programmers, and medical writers

　　 Expert knowledge of FDA and ICH regulations and industry standards applicable to clinical programming

　　 Desired Medical or mathematics/computer science, or data analytics background a plus

　　 Detailed knowledge and experience in case report form design, central laboratories, programming databases, query resolution, data validation Knowledge of clinical trial design and basic statistics a plus

　　 Technical project management experience a strong plus Computer skills: knowledge of MS Office program suite

　　 Outstanding verbal and written communication skills, in addition to excellent organizational skills

　　 Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.

　　 Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient

　　Diversity, Equity & Inclusion

　　At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

　　Hiring diverse talent

　　Maintaining an inclusive environment through persistent self-reflection

　　Building a culture of care, engagement, and recognition with clear outcomes

　　Ensuring growth opportunities for our people

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.