Job ID: ABLJP00031030
Title: Project Manager/ Business Analyst
Location: 3200 Lakeside Drive, Santa Clara – AV, CA USA 95054
Duration: 1+ years W2 Contract
Primary Job Function Clinical Solutions (IT) Project Manager/ Business Analyst are viewed as a departmental resource capable of management. The core functions the role is listed below: - Handling top-priority projects;
- Mentoring or managing more junior Project Managers and business analyst in leadership and strategic skills;
- Acting as a business unit consultant or resource to other business units and teams;
This person can be assigned to non- IT project related activities, such as procedure/process teams with the intent to lead process improvements of moderate complexity. Core Job Function - Be recognized by the project team as an amiable team member and leader, respected for his/her abilities and expertise.
- Identify resource needs for a given project and elevate any constraints to the management team for resolution;
- Lead risk management activities by working with teams to identify risks and implement mitigation
- Generate a set of sound options and recommendations for management’s consideration in problem resolution
- Work with outside vendors and suppliers in contract development and negotiation;
- Solve complex problems within area of responsibility that require ingenuity and creativity
- Use superior writing and presentation skills to convey the idea or decision
- Excellent knowledge of CFR, GCP, local regulations and internal procedures required for clinical trials;
- Ensure compliance with applicable Corporate and Divisional Policies and procedures
Scope and Responsibilities - Requires minimal guidance in completing assignments
- Demonstrate the ability to influence others at a variety of levels and in different parts of the organization to achieve positive results and collaboration based on reputation, proven knowledge, and abilities.
- Ensure that projects are delivered on time and under budget
- Work with managers to identify new opportunities for team members relevant to the project
- Interact with management, the immediate supervisor and Clinical Research team members locally and internationally as required
Software Expertise - Experience with one or more of the following systems CTMS, Electronic Data Capture, IVRS, Clinical Document Control, Sharepoint, Safety Systems
- Medidata RAVE Product line experience is a plus
- SQL Programming is a must
· JAVA Programming |
SPECIAL SKILLS NEEDED
Minimum Education - Bachelor's or Masters degree in business, Information Services, or Computer Science.
- PMI or PMP certified required
Minimum Experience/Training - 7+ years of experience in professional consulting and program/project management
- 3+ years of supporting clinical research systems and users in a medical device or pharmaceutical company
- 4+ years of managing projects
- Must be able to explain 21 CRF Part 11 Electronic Records and Electronic Signatures and 21 CFR Part 820 Quality Systems and its impact on systems;
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Thank you,
Prem
Sr. IT Recruiter
US Tech Solutions, Inc.
Desk: 201.524.9600 x 128
Fax: 201-524-9601
Email id: prem@ustechsolutions.com
Web: www.ustechsolutions.com
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