Clinical Project Manager

Location: Santa Clara, CA, us

Company Description

About Collabera:

Established in 1991, Collabera is one of the fastest growing end-to-end information technology services and solutions companies globally. As a half a billion dollar IT company, Collabera's client-centric business model, commitment to service excellence and Global Delivery Model enables its global 2000 and leading mid-market clients to deliver successfully in an increasingly competitive marketplace.

With over 8200 IT professionals globally, Collabera provides value-added onsite, offsite and offshore technology services and solutions to premier corporations. Over the past few years, Collabera has been awarded numerous accolades and Industry recognitions including.

• Collabera awarded Best Staffing Company to work for in 2012 by SIA. (hyperlink here)
• Collabera listed in GS 100 - recognized for excellence and maturity
• Collabera named among the Top 500 Diversity Owned Businesses
• Collabera listed in GS 100 & ranked among top 10 service providers
• Collabera was ranked:
• 32 in the Top 100 Large Businesses in the U.S
• 18 in Top 500 Diversity Owned Businesses in the U.S
• 3 in the Top 100 Diversity Owned Businesses in New Jersey
• 3 in the Top 100 Privately-held Businesses in New Jersey
• 66th on FinTech 100
• 35th among top private companies in New Jersey
http://www.collabera.com/about_us/accolades.jsp

Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, Disability Insurance.

Job Description

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 

Qualifications

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

Additional Information

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