Clinical Project Manager

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

Skills – Program Management, Project Management, Technology Strategy, SDLC, Business Process Modeling, Vendor Management, User Adoption, System Training, Business Analysis

Clinical Research Functional Experience – Data Management, Clinical Safety, Biostatistics

Systems Experience – RAVE EDC, DS Navigator, SAS Programming, Reporting and Analytics, Siebel CTMS, Documentum

equirements

• 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.

• Experience with implementation of CTMS tool highly desired.

• Clinical Research experience in the Medical Device/Pharma industry is a plus.

Skills

1) Project Management

2) Business Analysis

3) Business Process Modeling

4) Clinical Technology Strategy

5) User Adoption

6) System Training

7) Vendor Management

Systems Experience

1) RAVE EDC

2) CTMS (preferably Oracle CTMS, Medidata CTMS, BioClinica CTMS, ArisGlobal CTMS)

3) eTMF Solutions (i.e. VEEVA, Documentum, NextDocs)

4) Safety Database

5) Reporting and Analytics

6) DS Navigator

7) SAS Programming

All your information will be kept confidential according to EEO guidelines.