Project Coordinator I W2 ONLY 7325048

South San Francisco, CA

Post Date: 08/09/2017 Job ID: 3094 Industry: Professional Positions

W2 ONLY   12 Month Contract


Job Purpose:

The Systems Operations Coordinator/Generalist (SOC) ensures the ongoing day-to-day maintenance of clinical systems; providing general and business support to clinical operations users and ensuring the clinical systems are operating in a stable manner.

This position will serve as a liaison between the Systems Operations Group in collaboration with multiple business partners including Program and Study Management, IT, and Data Management. The SOC has high level understanding in project management, customer service and knowledge base of gRED’ s Clinical Operational business needs and tools.

Primary Responsibilities and Accountabilities

• Responsible for the project management activities related to the development, deployment, maintenance and decommissioning of software systems as they pertain to gRED Clinical Trials

• Responsible for ensuring prompt resolution of system issues and provides timeline and accurate responses to end users and other stakeholders

• Partner with Systems Operations team members to assist in set-up and coordination of system startup, maintenance and close down activities and associated meetings

• Coordinates and manages project timelines for system-related activities such as start-up, UAT, enhancements and closeout

• Collaborates with Systems Operations team members to manage User Acceptance Testing (UAT) process from development through execution on various clinical systems, including managing system defects through resolution

• Collaborates with Systems Operations team and other stakeholders to generate test case scenarios specific to customized system design.

• Manages 3rd party vendor relationship throughout UAT execution to maintain business partnerships

• Manages gRED specific clinical system logistics for continuity of business processes and system performance

• Responsible for user management process for gRED specific clinical systems in collaboration with internal and external stakeholders to ensure all service level agreements are upheld

• Collaborates with gRED IT Operational team to resolve end user requests and issues

• Reports into gRED Systems Operations Sr. Clinical Study Systems Implementation Leader

• May participate on system related projects with internal gRED ClinOps stakeholders, our client' s system stakeholders, and gRED ClinOps preferred CRO partners to ensure: (1) operations, (2) data availability and (3) data integrity to the information which is used to manage gRED ClinOps business




• Knowledgeable with Clinical Operations and Information Systems such as CTMS, EDC, IxRS, Planisware, and Clinical Supply Systems
• Broad knowledge of applied GxP experience in pharmaceutical or Biotech industry with clinical drug development experience
• Knowledgeable with processes and principles of project management

• Proven ability to drive discussions and issues to resolution ensuring on time completion of deliverables
• Familiar with managing third party vendors in delivering service as expected through contracting process and support organizations
• Familiar in Software Development Life Cycle including requirements/specifications development and/or user acceptance testing for computer systems
• Knowledgeable with User Acceptance Testing methodologies
• Proficient problem solving skills as related to software systems
• Demonstrated ability to function independently with a proactive, self-starter attitude
• Highly proficient in MS Excel, MS Project, MS Word
• Highly effective verbal & written communication skills
• Highly effective team player and interpersonal skills (globally, internally and externally)
• Strong customer focus




·          Bachelors degree

·          3+ years experience in Biotech/Pharmaceutical industry

Calley Molina

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