Planet Pharma · 8 hours ago
Systems Designer / Analyst II
Irvine, CA
Full-time
Onsite
Mid, Senior Level
$29/hr - $39/hr
3+ years expPlanet Pharma is a leading company in the clinical trials data space, and they are seeking a Systems Designer / Analyst II to ensure the successful delivery of data and statistical sciences projects. The role involves designing Electronic Data Captures (EDC) systems, ensuring adherence to regulatory standards, and collaborating with cross-functional teams to meet program objectives.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Ensures that the requirements of each study protocol are reflected in the Electronic Data Captures (EDC) design and that common data standards are used
Ensures that EDC is specified to optimize on functionality, end user experience, and data flow
Accountable for the on-time design and delivery of new EDC systems, integrations between EDC and other applicable systems (e.g. IRT)., as well as any required changes to EDC. Utilizes project management tools to track study progress and plan work. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions
Ensures that TA- and program-level consistency is achieved
Interacts with and influences DSS and cross-functional team members to achieve program and study objectives. Ensures that assigned work product is synchronized with upstream and downstream dependencies
Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development
Utilizes project management tools to track study progress and plan work. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions
Participates in DSS and cross-functional innovation and process improvement initiatives
Experience with common industry design and development tools preferred
Demonstrated understanding of clinical trial process
Knowledge of CDASH and SDTM
Demonstrated ability to influence of others without direct authority
Demonstrated effective communication skills
Demonstrated effective analytical skills
Qualification
Required
Bachelor's degree in business, management information systems, computer science, life sciences or equivalent
Must have 3+ years of clinical technology experience (EDC) or 5+ years of experience in a similar technical role or in a clinical development role
Demonstrated understanding of clinical trial process
Knowledge of CDASH and SDTM
Demonstrated ability to influence of others without direct authority
Demonstrated effective communication skills
Demonstrated effective analytical skills
Preferred
Masters preferred
Experience with common industry design and development tools preferred
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase