Clinical Project Manager
About The Position
Job Description for Clinical Solutions Project Manager – Contract position Oversight and management of Clinical Trial systems used by Clinical Research organization Program and Project Management for Clinical Systems projects including system updates, enhancements, and new system implementation Author project documentation including Project Charters, Business Requirements etc… Develop and present Clinical System strategies and roadmaps. Partner with global Clinical Research functions to identify business needs and propose new/enhance existing clinical system solutions. Drive adoption of and facilitate change management of clinical systems in the global Clinical Research function Develop and Conduct clinical systems training for Global Business End Users Manage System Vendor relationships. Provide global production support activities
Requirements
- BA or BS degree in technical or scientific discipline required.
- 8+ years of experience implementing systems in GxP controlled environment including responsibility for the implementation of either an EDC, Safety or CTMS system.
- Strong interpersonal and communication skills; ability to interact with different levels of management.
- Project Management
- Business Analysis
- Business Process Modeling
- Clinical Technology Strategy
- User Adoption
- System Training
- Vendor Management
- RAVE EDC
- CTMS (preferably Oracle CTMS, Medidata CTMS, BioClinica CTMS, ArisGlobal CTMS)
- eTMF Solutions (i.e. VEEVA, Documentum, NextDocs)
- Safety Database
- Reporting and Analytics
- DS Navigator
- SAS Programming
Nice To Haves
- Experience with implementation of CTMS tool highly desired.
- Clinical Research experience in the Medical Device/Pharma industry is a plus.
Responsibilities
- Oversight and management of Clinical Trial systems used by Clinical Research organization
- Program and Project Management for Clinical Systems projects including system updates, enhancements, and new system implementation
- Author project documentation including Project Charters, Business Requirements etc…
- Develop and present Clinical System strategies and roadmaps.
- Partner with global Clinical Research functions to identify business needs and propose new/enhance existing clinical system solutions.
- Drive adoption of and facilitate change management of clinical systems in the global Clinical Research function
- Develop and Conduct clinical systems training for Global Business End Users
- Manage System Vendor relationships.
- Provide global production support activities
Benefits
- paid vacations
- holidays
- personal days
- Medical
- Dental and Vision insurance
- 401K retirement savings plan
- Life Insurance
- Disability Insurance
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What This Job Offers
Career Level
Manager
