Manish Patel Email & Phone Number

PA

• Lead cross functional team meeting for DM tasks and establish expectations for dataset content and structure. Actively work with CRO for Study Set Up activities, grant access for various CRO roles, provide training as.
• Ensure real-time inspection readiness of all Integrated Data Services (IDS) deliverables for the trial. Participate in Regulatory Agency and Johnson & Johnson internal audits as necessary.
• Perform trial level oversight controls as described in the oversight plan, QC process and work instructions. Review clinical data management documents (including submission package) ensuring appropriate quality.
• Identify and communicate lessons learned, best practices and frequently asked questions at the trial level.
• Supported vendor evaluation, selection, contracting, and oversight activities for Global Data Management.
• Set up Clinical Study database in RAVE iMedidata Set up. Lead UAT process & compliance documentation.

NJ

• Responsible for the overall leadership of the DM Systems (Oracle Clinical, RAVE iMedidata) capabilities including operational governance of EDC platforms enabling Data Management & Study team best practices, delivering.
• Effectively managed projects via engaging key stakeholders as per governance strategy to ensure business needs and requirements are met, prioritized, and communicated. Prepared and presented summary to executive team
• User Administrator responsibility for RAVE and OC, managing Site, Internal & External user roles, and functionality of the EDCs. Accountable for system performance, implementation of system enhancements, project.
• Actively supported authority inspection via grant/revoke access, providing study users role info and documents.
• Developed training curriculum for GDM, Site & Sponsors. Reviewed and approved vendor assignments and invoices.
• Plan and track content, format, quality, and timing of data management deliverables, including, eCRF, RAVE EDC set up, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan.

PA

Perform all Clinical Data Management and Clinical Programming activities.

North Wales, PA

New Haven, CT

Start-up of clinical data management & programming functional team within Clinical Affair, Regulatory dept. Annual budget forcasting & performance evaluation of direct reports. Managing, training & mentoring Oracle Clinical, RDC On Site, TMS & Siebel Clinical (CTMS) team. GLIB development based on CDISC - SDTM standards. Create & implement several SOPs and.

Groton, CT

Project Manager, Trainer, SME, Clinical Data Manager, Clinical Database Programmer, Manage CROs, FSPs, Global Clinical Data Systems & Work assignment.

Collegeville, Pennsylvania, United States

CRF designer, OC Database programmer, GLIB set up in Oracle Clinical

Ms, Computer Information Systems

Bs, Medical Technologist