Data Team Lead Resume NJ - Hire IT People

SUMMARY

10+ Years Industry Experience, 8+ years as a Lead Data Manager in Oncology Phase 1, 2 and 3 trials. Integral in cleaning and preparing Phase 3 trials for Interim Analysis, Primay Analysis and Database Locks. All years of experience include hands on work with Data in CRO and Sponsor capacity.

PROFESSIONAL EXPERIENCE

Confidential NJ

Data Team Lead

Responsibilities:

Lead Data Management Activities in Oncology Phases 1, 2 and 3
Protocol review
Design, Review and Approve eCRFs
Develop Edit Checks
Coordinate and Perform UAT of Database Screens and Edits
Work within cohesive team in cleaning and tracking multiple Phase 3 studies with 900+ patients
Data review and reconciliation (SAE and 3rd Party Vendors)
Study closeout activities
Database lock activities
Chair client meetings and provide detailed study status reports
Build/Maintain trusting relationships with clients and team
Participate in initiatives
Mentor Junior staff
Act as primary point of contact for DM related activities
Deliver Quality results within specified timelines
Compliance with company / client SOPs and ICH - GCP guidelines

Confidential, NJ

Lead Clinical Data Manager,

Responsibilities:

Lead Data Management activities in Oncology Phases 1, 2, 3 and 4
Assist on Data Management tasks for Phase 3 studies preparing for Major Milestones (query generation, resolution, tracking, reconciliation)
Manage CROs to ensure quality set up and clean database delivery
Manage CROs to ensure deliverables are met
Lead efforts in CRF design, review and approval
Performing SAE and external data reconciliation e.g., lab data
Review and approve Data Management Plans, Budgets, and Contracts
Provide status updates, timelines and define project and trial level data management strategy.

Confidential, NJ

Project Manager

Responsibilities:

Responsible for study set-up, maintenance, and closeout activities for Phases 1, 2, 3 and 4 studies across multiple therapeutic areas.
Develop and maintain study documentation.
Maintain excellent customer care.
Presentations at Investigator Meetings
Maintain Study Budget
Chair and participate in internal and client meetings
Monitor timelines, deliverables
Proactively detect and communicate any problems to team .
Provide status reports to clients according to Work Order Specification Document development
QC study or client documentation and databases.
Maintain electronic project files
Assist with the Digital ECG Community activities.
Responsible for reading SOPs and being proactive with training needs
Archive studies