Project Manager
2-Months: Planning & Design
· System Due Diligence Assessment/Documentation:
o Coordinate Audit requirements (i.e. Vendor BT VCAS Assessment and others).
o Develop System Documentation.
o Develop process documentation (including manual data entry).
· Conduct company Consultation Process with company Investigator and Internal users:
o Coordinate discussion with SSU and Investigator to establish contract contact.
o Endure site acceptance/usability of the tool.
US Pilot Implementation & Reporting - 4 months
• Manage Training:
o Develop Training Materials.
o Investigate site and user training in use of OLN tool.
o Conduct system module training.
o Develop required documentation (i.e. SOP etc.).
• Conduct ONL Pilot:
o Identify the optimum Pilot design to realize a robust OLN assessment.
o Conduct Pilot with the pilot studies identified and conduct follow up.
o Implementation Feedback-sites and CRO's.
o Assessment of negotiation metrics & user feedback.
• Assess Grants Plan/IMS OLN System Reporting Needs:
o Assessment study reporting capabilities.
• Assess success:
o Identify success measures.
o Evaluate Pilot success.
o Develop transition plan to US full implementation.
ROW Pilot Implementation & Reporting - 3 months
• Manage Training:
o Update Training materials.
o Investigate site and company user training in use of OLN tool.
o Conduct Module System training.
· Conduct OLN Pilot
o Identify the optimum Pilot design to realize a robust OLN assessment.
o Conduct Pilot with pilot studies identities and conduct pilot follow up.
o Implementation Feedback-Sites and company/company CROs.
o Assessment of negotiation metrics & user feedback.
• Assess Success
o Identify success measures.
o Evaluate Pilot Success.
o Develop transition plan to ROW full implementation.
• Lead Change Management & Communications
o Develop OLN tool introduction.
o Develop communication materials required.
o Provide regular updates to key stakeholders.
No Travel Required.
Critical Skills:-
• Great Communicator
• Great Planner
• Deliverable oriented.
• Must have background in Pharma and/or Clinical Operations
Warm Regards
Ricky Bansal
732-429-1925
ALTEN
Assystems
AntonPaar1