The Data Management Programmer I/II will perform data management programming for clinical trials as well as extramural partner trials.
The Data Management Programmer I/II will support all platforms and integrations, and will primarily manage electronic data collection and access, all in accordance with GCP and SOPs.
BS/MS and/or 8+ years of relevant industry experience.
3+ years of relevant experience in clinical data management and data management programming, oncology trial experience preferred; expertise in the acquisition and management of data from multiple sources
Clinical Trial Management (CTM) Analyst is responsible for supporting systems/processes within the Clinical Trials Management Solutions team such as Clinical Trial Management System (CTMS) and Grants Manager.
Work with Study Teams and partners during study build process to create/maintain the following in CTMS
Study, Country, Site, Contacts, and Institution records
Create and set up templates such as Health Authority, IRB/IEC, Financial Disclosure, Subject Visit, Visit/Trip Report, etc.
Update system dropdown values
Create/Update assignments, configurations, properties, attributes, triggers, and parameters in the system.
Add Payees and study triggers
Subject deviations/central findings
Any other general study build activities
Troubleshoot integration errors between CTMS and other applications
Position Roles & Responsibilities:
5 years of work experience is required, and Commercial Sponsorship Coordinator Specialist will be responsible for overseeing the compliant execution, process management and administration for the electronic approval system supporting Sponsorship and Exhibit requests.
Oversight for activities such as coordinating training, identifying and resolving systematic and process issues and concerns, partnering with key business stakeholders and the third party service provider(s) to enhance the system’s effectiveness and efficiency, monitoring transactions, document flow, approvals and exceptions and developing report
Serve as a key compliance resource for stakeholders across the commercial organization.
December 4, 2017 – Senior Manager for Global Risk Management – p b Job description: /b /p ul li Preparing and updating risk management plans (e.g. REMS, EU-RMPs) for product submissions including NDA and
October 31, 2017 – Clinical Trial Management System Consultant – p b Roles and Responsibilities: /b /p ul li CTMS Administrator/Programmer to configure, deploy, test and support our CTMS system (BioClinica
August 30, 2017 – Service Management Specialist II – p b Primary Role /b /p ul li Provide a brief summary describing the major role, responsibilities and purpose of the job. Summarize key areas of
July 23, 2017 – Clinical Documents Management Specialist – p b Responsibilities: /b /p ul li Operational responsibility to set-up the local Trial Master File (eTMF) and Investigator Site File including