MIRATI THERAPEUTICS, INC. – $139,568.00/Year

Contd from H.8 In lieu of Masters degree and 3 years of experience, employer will accept a Bachelors degree or equivalent in Life Sciences, Health Services, Computer Science, Mathematics, or a related field and 5 years of progressive clinical data management experience to include any relevant job titles within this occupation in the CRO, pharmaceutical, or biotechnology industry.br Contd from H.10B. clinical data management experience to include any relevant job titles within this occupation in the CRO, pharmaceutical, or biotechnology industry.br br In H.12, job requirements are normal for the employer due to the complexity of job duties associated with this position and common in the industry. Employer answered no to Question H.12 based on SVP analysis only.br br Work experience to include 1. Working in EDC clinical data management system. 2. Utilizing clinical data management principles, supporting clinical trials processes, and working with regulatory requirements. 3. Utilizing MedDRA and WHODrug medical coding dictionaries. 4. Working with industry standards CDISC, SDTM, and CDASH, SAS, 21 CFR Part 11, ICH guidelines, and FDA regulations. 5. Performing data management activities for clinical studies, including development of internal data management processes. 6. Supporting clinical studies from inception to close, including reviewing and contributing to study protocols, CRF Case Report Form design, performing and coordinating UAT User Acceptance Testing, reviewing CRF completion guidelines, data management plans, edit check specifications, external data transfers, performing data quality checks, discrepancy management, and database lock activities. 7. Collaborating with multidisciplinal teams including any 2 of the following Clinical Science, Biostatistics, Medical, Clinical Safety, or CROs for database development, CRF design and standardization, data review and cleaning, database lock, and receipt of final database deliverables. 8. Supporting analysis of regulatory submissions, safety monitoring, and publications. 9. Participating in the development of data management Standard Operating Procedures SOPs, processes and CRF standards to ensure adherence to industry standards CDISC, SDTM, and CDASH, Good Clinical Practices GCP, Good Clinical Data Management Practices GCDMP and internal and external customer requirements.