Clinical Systems Associate
South San Francisco, CA | Contract
Bayside Solutions is seeking a Clinical Systems Associate to be part of our Client’ s team in South San Francisco. This is an opportunity to work with a local Biotechnical company focusing on the discovery, development, manufacturing and commercialization of medicines to treat patients with serious or life-threatening medical conditions.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website atwww.baysidesolutions.com.
Clinical Systems Associate
- An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Responsible for the project management activities related to the development, deployment, maintenance and decommissioning of software systems.
- 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.
- Coordinate and manage project timelines for system-related activities such as start-up, UAT, enhancements and closeout.
- Collaborate 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.
- Collaborate with Systems Operations team and other stakeholders to generate test case scenarios specific to customized system design.
- Manage 3rd party vendor relationship throughout UAT execution to maintain business partnerships.
- Must have a Bachelor’ s degree and 3+ years’ experience in Biotech/Pharmaceutical industry.
- 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 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).