Job Description :
Title : Project Coordinator
Duration : 12 Months
Location : South San Francisco, CA

Duties:
The Systems Operations Coordinator/Generalist (SOC) ensures the ongoing day-today 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 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 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 specific clinical system logistics for continuity of business processes and system performance
Responsible for user management process for specific clinical systems in collaboration with internal and external stakeholders to ensure all service level agreements are upheld • Collaborates with IT Operational team to resolve end user requests and issues
Reports into Systems Operations Sr. Clinical Study Systems Implementation Leader • May participate on system related projects with internal ClinOps stakeholders, system stakeholders, and ClinOps preferred
CRO partners to ensure:
(1) operations, (2) data availability and (3) data integrity to the information which is used to manage ClinOps business


Skills:
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

Education:
Minimum: Bachelor’s degree • 3+ years’ experience in Biotech/Pharmaceutical industry