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Clinical Study Data Lead

Company: Maverick Technology
Location: Hamilton
Posted on: October 9, 2020

Job Description:

Responsibilities Study Delivery 1. Provides support and training on the Clinical data management activities to TCS Data Managers for the relevant functional processeswork statementsprojects - be trained and perform as back up where required 2. Maintains builds awareness of internal and external clinical Data Management practices to enhance domain expertise 3. Single point of contact for Roche Study Data Manager designee Study Project Management 4. Overall in-charge of all Data Management activities for a studyies including Study Set up, Conduct and Close Out. 5. Primary point of contact for CDM and works are liaison for CP, DAS and CCS activities too 6. Monitors and evaluates overall study progress, identify the potential risk challenges faced during the course of the study 7. Conducts regular team meetings for study updates and provides guidance on study related issues to Roche as well TCS internal teams 8. Monitor, maintain report KPI SLAs metrics on the study 9. Performs tasksactivities as communicated by the TCS Group Leader (GL) and or Project Manager (PM) and Roche Study Data Manager (SDM) 10. Ensures adequate resource for the Study throughout its lifecycle in collaboration with Group leader and informs Roche (SDM andor Alliance Manager (AM) as applicable) contact of any changes in staff 11. Keeps TCS Group Lead Project Manager fully informed about the need for the resources so the resource requests can be finalized with Roche AM and TCS PM 12. Keeps record of all activities to ensure the smooth flow of the study throughout its lifecycle 13. Set priorities and targets of the study within the CP, DM, CCS, DAS teams 14. Responsible for recruitment, selection, training of team members managing attrition 15. Works as mentor for DM staff assigned on the studyies Training Communication 16. Provide regular status reports to TCS Group Lead and Roche Study Data Manager (SDM) 17. Proactively communicate escalate the identified unresolved issueschallenges to TCS Group Lead and or Project Manager and Roche Alliance manager Study Data Manager (SDM) 18. Communicate between different stakeholders and Roche Study Data Manager (SDM) 19. Identify training needs for team members and maintains documents of staff training assessments including updates. 20. Actively contributing in creation of Investigator Meeting slides and attending the SMT meetings Quality 21. Ensure the team members deliver high quality work and follow effective Data Management processes within the function 22. Ensures compliance of the team with all relevant Roche and TCS SOPs and all documentation requirement of staff training assessments People 23. Responsible for ongoing monitoring development of study team at functional level 24. Assist Group lead in recruitment and selection of the team members from a domain technical evaluation perspective 25. Responsible for assessing the performance of Data Managers and reporting the progress to Skills Required 26. Excellent Technical skills, start-up knowledge is must 27. Excellent verbal and written skills, good organizational, interpersonal, and team skills 28. Project management result orientation 29. Excellent Planning and Organizing skills 30. Strong knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology

Keywords: Maverick Technology, Hamilton , Clinical Study Data Lead, Other , Hamilton, Ohio

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