Header

Project Manager/ Business Analyst - Santa Clara, CA

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:

  1. Handling top-priority projects;
  2. Mentoring or managing more junior Project Managers and business analyst in leadership and strategic skills;
  3. 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

  1. Be recognized by the project team as an amiable team member and leader, respected for his/her abilities and expertise.
  2. Identify resource needs for a given project and elevate any constraints to the management team for resolution;
  3. Lead risk management activities by working with teams to identify risks and implement mitigation
  4. Generate a set of sound options and recommendations for management’s consideration in problem resolution
  5. Work with outside vendors and suppliers in contract development and negotiation;
  6. Solve complex problems within area of responsibility that require ingenuity and creativity
  7. Use superior writing and presentation skills to convey the idea or decision
  8. Excellent knowledge of CFR, GCP, local regulations and internal procedures required for clinical trials;
  9. Ensure compliance with applicable Corporate and Divisional Policies and procedures

Scope and Responsibilities

  1. Requires minimal guidance in completing assignments
  2. 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.
  3. Ensure that projects are delivered on time and under budget
  4. Work with managers to identify new opportunities for team members relevant to the project
  5. 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;

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