Clinical Systems Leader
475 E Grand Ave., SSF42 South San Francisco, CA 94080
Bayside Solutions is seeking a Clinical Systems Leader to be part of our client’ s team in South San Francisco. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
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 at www.baysidesolutions.com.
Clinical Systems Leader
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- 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:
- Accountable to the team and partners with the PET to efficiently deliver effective clinical systems and solutions
- Manages the end-to-end specifications for the build of all clinical trial systems needed for a given study, including requirements reviewing, testing, deployment, maintenance, and supporting infrastructure
- Continually assesses the needs of the PET, consults the PET, and proactively finds system and solution recommendations to address their needs
- Serves as first line of contact for all support requests for each clinical study
- Ensures prompt resolution of critical system issues and provides timely and accurate responses to users, per the standard operating procedures
- Identifies business needs / issues and provides technical solutions to address
- Gathers, receives and interprets requirements from end users and documents business requirements
- Monitors key performance indicators and conducts analysis to identify root causes for defects and recommend process improvements
- Identifies process inefficiencies and compliance gaps and participate in process improvement initiatives
- Acts as the subject matter expert for Sys Ops supported systems
- Develops strong relationships and maintains effective communication within the ClinOps, as well as other functional departments within the company
- Reports to the Clinical Operations Sys Ops Manager
Summary of Qualifications:
- Bachelor’ s degree (MBA or advanced degree preferred)
- 5+ years’ experience in Biotech/Pharmaceutical industry
- Knowledgeable with the processes and principles of program and project management and business analysis
- Up-to-date knowledge of clinical operations processes and information systems
- Experience managing third party vendors in delivering quality service as expected
- Ability to see the interrelationship of systems and procedures within a project and understand their interdependencies
- Broad knowledge of applied GxP experience in pharmaceutical or Biotech industry with clinical drug development experience
- Previous experience in clinical trial planning and execution
- Ability to successfully lead a team or change initiative through implementation with little or no oversight
- Knowledgeable with Clinical Operations and Information Systems such as EDC, IxRS, Crystal, FELIx, and Clinical Supply Systems
- Demonstrated leadership and project management skills
- Ability to drive results to successful completion
- Analytical problem solving skills to enable ability to define problem statement clearly and accurately and apply structured and disciplined methodology to identify root-causes
- Comfortable working in a fast-paced, dynamic environment
- Highly proficient in Microsoft Excel, Microsoft Project and Microsoft Word
- Highly effective verbal & written communication skills
- Highly effective team player and interpersonal skills (globally, internal and externally)
- Strong customer focus