at IQVIA in Calais, Maine, United States
Principal Data Manager position is to oversee data operations tasks for a team of data managers from study start-up to database lock, to produce a clean and analyzable database.
+ Serve as Data Team Lead (DTL) on a program of 6-10 global clinical trials or 40+ increasingly complex central laboratory studies
+ Provide leadership to CDM team.
+ Manage CDM customer relationship for CDM project team to include leading (with minimal guidance) CDM customer negotiations on complex timeline, budgetary and other issues.
+ Provide marketing capabilities presentations and business development presentations. . Or serve as Data Operations Coordinator (DOC) for one or three global clinical trials with fewer than 25 operations staff (excludes DE) or 20-40 central laboratory studies, or serve in a leadership role to a specific DM Task.
+ Serve as back-up for Data Operations Coordinator or Data Team Lead
+ Provide leadership to Operations team
+ Provide technical expertise. Or serve as a Subject Matter Expert (SME)
+ Provide leadership and expertise in a specific CDM task or technology. Manage delivery of projects through full data management process life-cycle.
+ Project timelines
+ Quality issues
+ Resource management
+ SOW (scope of work) / budget.
+ Provide justification for customer negotiations.
+ May serve as Project Manager for single service data management projects.
+ Manage comprehensive data management tasks pertaining to the documented project specifications.
+ Manage comprehensive quality control procedures.
+ Provide data management expertise and data management process improvement to CDM management.
+ Mentor other team members in training and developing data management expertise.
+ Independently bring project solutions to the CDM team and the CDM Department.
+ Manage a focus team or a best practice team.
+ Manage the development and implementation of new technology/tool.
+ Present at professional conferences and/or publish articles in professional journals.
+ Provide CDM with technical expertise.
+ Provide review and expert opinion in developing, revising, and maintaining core operating procedures and working instructions.
+ Perform other duties as directed by the functional manager.
+ Meet objectives as assigned.
+ Develop and maintain good communications and working relationships with CDM and project teams."
+ Bachelor’s Degree in clinical, biological or mathematical sciences, or related field or nursing qualification Required
+ 5 years relevant experience including proven competence in managing delivery of multiple projects simultaneously through full data management study life-cycle , including large trials >1000 patients , and including experience handling customer negotiations (e.g. bid defense meetings) is Required, or Equivalent combination of education, training and experience.
+ Experience working with Medical Devices/Wearables including ECG, Spirometry, ABPM/HBPM/OBPM, CGM/BGM, Actigraphy and Vitals.
+ Thorough knowledge of the data management process and experience in specialized data management skills (e.g., therapeutic, extensive knowledge, SAE reconciliation, central laboratory, and/or new technology.
+ Comprehensive understanding of clinical drug development process (detail oriented).
+ Knowledge of operating procedures and work instructions, and the ability to apply them in practice.
+ Excellent experience and organizational, communication, and demonstrated expert data management skills.
+ Ability to establish and maintain effective working relationships with coworkers, managers and clients.
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status
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