Manager - IT Clinical Systems
Well established international contract research organization serving both commercial as well as government markets, is conducting a search for a full time Manager of IT Clinical Systems to be based at the company's headquarters in Princeton NJ.
Responsibilities:
Manage the development and validation of IWRS and EDC study builds and the associated data listings, reports and data transfers.
Coach, develop and provide continuous feedback to direct reports / Provide guidance and direction to ensure departmental and client/project goals are met.
Maintains detailed timelines for each study build.
Ensure internal and external deadlines are met, and work is kept within budget.
Create strategies and best practices to increase efficiency.
Develop and track metrics on productivity and quality.
Define and communicate capacity of the study build team. Be proactive in anticipating resource challenges and finding creative solutions.
Simultaneous manage the development and validation of IWRS, EDC, and reports for numerous new studies and protocol amendments.
Lead weekly cross-departmental Study Build status meetings. Effectively allocate resources and lead efforts to agree on solutions.
Represent IT in cross-functional teams.
Ensure that the team adheres to SOPs and GCP regulations.
Requirements:
Bachelor's degree
4
years related experience managing EDC study builds, preferably in a CRO environment.
Prior experience directly managing staff members and high performing teams.
2
years Oracle Clinical / Remote Data Capture (OC/RDC) experience
Solid working knowledge of GCPs, CFR Part 11 and computer systems validation.
Strong leadership, collaboration and organizational skills with the proven ability to successfully manage numerous, simultaneous projects and meet deadlines.
Strong analytical, problem-solving and excellent communication skills (written and oral) are essential.Estimated Salary: $20 to $28 per hour based on qualifications.
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