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Clinical Systems Leader

South San Francisco, CA 94080

Posted: 03/10/2023 Employment Type: Contract Job Category: Clinical Development and Operations Job Number: 547460 Is job remote?: No Country: United States

Job Description


Summary:

The Clinical Systems Leader (CSL) role sits within the R&D Early Clinical Development Informatics (ECDi) Systems Operations (Sys Ops) Team. The CSL ensures that clinical systems are appropriately setup and operational for Early Clinical Development (ECD) Trials. The CSL interfaces with Protocol Execution Teams (PETs) and other internal stakeholders, serving as the primary point of contact for clinical systems at the individual study or project level. The CSL has expertise in Systems Development Lifecycle (SDLC), Business Systems Analysis, Project Management, and Vendor Management.

Job Responsibilities
  • Accountable to and partners with PET members including Clinical Operations, Biostatistics, Clinical Supplies, Data Management, and Vendor PMs, to deliver high quality and efficiently designed systems.
  • Manages the end-to-end specifications for the build of outsourced clinical trial systems needed for a given study, including requirements review, testing, deployment, maintenance, and enhancements.
  • Manages and executes UAT processes for various systems, including test case generation, defect management and resolution
  • Serves as a crucial stakeholder for systems support requests for clinical studies.
  • Assesses the needs of the PET continually, and proactively finds and recommends system solutions.
  • Ensures prompt resolution of system issues and provides timely and accurate root cause analysis,

escalation, and issue tracking support.
  • Gathers, receives and interprets requirements from end users and documents business requirements.
  • Monitors key performance indicators (KPIs) and conducts qualitative analyses to identify root causes for defects and recommends process improvements.
  • Identifies process inefficiencies and compliance gaps and participates in process improvement initiatives.
  • Acts as a subject matter expert for Sys Ops supported systems.
  • Develops strong relationships and maintains effective communication with Clinical Operations, Clinical Science, and other functional departments.

Job Requirements Education:
  • Bachelors degree (advanced degree preferred)
  • 2+ years experience in Biotech/Pharmaceutical industry

Experience, Skills, Knowledge:
  • Working knowledge of SDLC, project management, business systems analysis, and product development.
  • Knowledgeable with clinical trial systems and technologies, including: IxRS, EDC, eCOA, eConsent, CTMS, and Clinical Supply Management Systems, and Wearables.
  • Knowledgeable with User Acceptance Testing (UAT) methodologies
  • Ability to successfully lead a team or project through planning, implementation, maintenance, and decommissioning with little or no oversight.
  • Ability to see the inter-relationship of systems, data flow, and procedures within a project and understand their interdependencies within the company wide ecosystem.
  • Up-to-date industry knowledge of clinical operations processes and supporting information systems.
  • Experience managing third party vendors in delivering quality products and service per expectations.
  • Broad knowledge of applied GxP experience in Pharmaceutical / Biotech industry.
  • Demonstrated leadership and influencing skills across technical and non-technical stakeholders.
  • Ability to drive results to successful completion, and proactively share learnings.
  • Excellent issue management skills to identify root-causes, and manage corrective/ preventative actions.
  • Analytical problem-solving skills to define clear problem statements and apply structured and disciplined methodology to intelligibly solution systems, processes, and issues.
  • Comfortable working in a fast-paced, dynamic, and highly matrixed environment.
  • Proficient in productivity software including: Microsoft Suite, Google Suite, Slack, SharePoint, and Trello.
  • Highly effective verbal and written communication skills.
  • Diligent team player with attentive and engaging interpersonal skills.
  • Strong customer focus.



Target Pay Rate Range: $55-65/hr. Salary will be commensurate with experience 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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