Project Manager

SUMMARY:

- Seeking a PM who can plan and execute a deployment of a tool in a Real Time environment
- Handle risk and contingency planning, Maintain and document issues
- Update training materials to make it more company-specific. Understand what existing training materials are, and how to make it fit with the company.
- Planning and Design
- Develop process documentation (including manual data entry).
- Conduct Consultation Process with Investigator and Internal users
- Coordinate discussion with SSU and Investigator to establish contract contact
- Endure site acceptance/usability of the tool. US Pilot Implementation and Reporting
- Manage Training
- Develop Training Materials investigator site and user training in use of OLN tool.
- Conduct system module training
- Develop required documentation (ie SOP etc.)
- Conduct OLN Pilot
- Identify the optimum Pilot design to realize a robust OLN assessment
- Conduct Pilot with the pilot studies identified and conduct follow up
- Implementation Feedback sites and CRO's
- Assessment of negotiation metrics and user feedback
- Assess Grants Plan/IMS OLN System Reporting Needs
- Assess success
- Identify success measures
- Evaluate Pilot success
- Develop transition plan to US full implementation
- ROW Pilot Implementation and Reporting - 3 months
- Provide regular updates to key stakeholders

SKILLS:

SKILLS:

- Great Communicator
- Great Planner
- Deliverable oriented
- Project Timelines
- NOT looking for an IT person, not technology, it is much more of a process person they are looking for. Communicating with clinical trials team, outsourcing/operations group and other stakeholders.
- Must have experience with all phases of managing a project and great communication skills
- Experience in a Pharma environment specifically with contracting in a clinical trial.
- Very little guidance and coaching, needs to have the experience with great ideas for the team
- Needs to provide feedback in a fast paced environment via emails, IM, etc
- Clinical experience: Ideal candidate has already dealt with this at other sites. Implementing a tool that will help with contract negotiations. Site contracting processing and supporting trials. Understand the roles of people involved with clinical trials.
- Must know how to run a project, plan, understanding stakeholder requirements, provide high level project plans, implementing a tool.
- PMP helps but not required
- OLN: online negotiation