Orion Business Innovations Careers
Program Overview and Objectives To Increase TMF completeness by implementing EDL milestones in eTMF Vault for Study Conduct and Closeout.
To enable greater compliance and TMF completeness checks for regulatory inspection readiness.
Leverage EDL (Expected Document List) from SSU SIP implementation.
Enable Veeva Vault Clinical EDL capability to provide greater Oversight and Reporting from Study startup Study Conduct Closeout phases Project Approach Update the Veeva Clinical Vault Configuration for milestones and expected document lists (EDLs) for study conduct closeout.
Make appropriate changes to CTMS eTMF interfaces Phased approach for Business adoption Initially to follow the approach of enabling four studies from SSU then follow up to enabling for all active studies that are on SSUSIP.
Project will include Communications Plan, Change management, and Training for impacted processes and users Delivery of a playbook for business adoption for 2021 adoption of EDL toolkit in eTMF Description of Services This project manager needs to drive and coordinate the project across multiple internal groups as well as with vendors who will be providing services.
The Project Manager will work across all work streams, with internal IT and vendors, to provide a comprehensive view of the program including management of integrated timelines, RAID items, dependencies, status, financials, and support for communications and updates to stakeholders of all levels.
Strong project management skills are required, along with strong communication skills which can be tailored to different stakeholders.
Knowledge of the clinical domain is a preferred.
Specific Activities Activity Project Manager 1.
Drive planning activities, develop and maintain an integrated project plan 2.
Define cadence of project team meetings 3.
Conduct project meetings and maintain mutual interaction with project team members, leaders, staff, vendors, and consultants 4.
Identify project and application risks, confirming mitigation and contingency plans are in place for identified risks in order to reduce the risk of failure and support success of the project.
Escalate risks as required.
5.
Track and monitor project issues and escalate as required 6.
Maintain the RAID Log 7.
Work with all teams to understand, plan and manage dependencies between activities.
8.
Ensure resource allocations and escalate resource deficiencies 9.
Provide weekly and monthly status updates to key stakeholders, project leads and the PMOProgram Manager 10 Inform senior leadership of key activities and create periodic progress reports summarizing project status, risks, and required actions and associated timelines.
Maintain and confirm accuracy of project documents and reports 11.
Facilitate communication within the project and across workstreams about issues, risks and decisions and other key program related communications 12.
Track project financials.
This includes updating project financial projections and reconciling with actuals 13.
Facilitate the creation of POs.
Track invoice approval.
Managing spending against POs and amendclose the PO as required.
14.
Support vendor management as required.