Biotech Jobs Foster City, CA GILEAD Senior Clinical Data Associate

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Senior Clinical Data Associate

Save this Job				ID: 374338
Company Name:	View All GILEAD Jobs	Approximate Salary:	Not Specified
Location:	Foster City, California	Country:	US
Industry:	Biotech	Position type:	Full-Time
Experience level:		Education level:
Short Description
BIOMETRICS
Long Description
: Ability to function in a study-lead role for 3 concurrent Phase I/II trials or 2 Phase III/IV trials in the antiviral therapeutic area (HIV, HCV, HBV), while delegating selected activities and acting as a mentor to other Clinical Data Associates. Utilize electronic data capture and management systems such as Medidata Rave or Phase Forward InForm, and/or manage the outsourcing of CDM services to CROs. Manage clinical data for trials in various stages (set-up, conduct, database freeze/finalization, and archiving), with goal of achieving data quality sufficient for analysis and regulatory submission, by leveraging standard eCRFs and corresponding edit checks, as well as data-review listings. High degree of collaboration required with Clinical and Statistical Programming, Biostatistics, external vendors, and cross-functional study management team members including Clinical Operations, Clinical Research, and Regulatory Affairs. Essential Duties and Job Functions: Works collaboratively with CRA, Statistical Programmer, Biostatistician and other Clinical, Global Drug Safety, Regulatory and Project Management staffs to meet project deliverables and timelines for non-routine clinical data acquisition, quality checking and reporting. Ensures completeness, correctness and consistency of clinical data and data structure. Responsibilities include: ensuring effective communication with vendors with a general understanding and expectation in terms of study timelines and milestones. May lead in the design and implementation of clinical data management process with CRO including data entry, data quality checking, data transfer, reporting, backup, and recovery. May lead in the design of CRF/eCRF for sound and thorough data collection through the regulatory approval process. Assist in the planning and implementation of the data management portions of clinical research projects. Reviews study protocols and assists site coordinators, investigators, and field clinical staff in collecting data to meet the protocol requirements in a timely manner. Identifies, tracks, and resolves non-routine queries. Utilizes reports to track study progress and ensure timeliness and quality expectations are met. Knowledge, Experience and Skills: Typically requires a BS degree in a Biomedical Science or equivalent and minimum 6 years of relevant experience along with clinical background/experience in Clinical Data Management in a CRO or bio/pharmaceutical setting, or a MS degree minimum 4 years of relevant industry experience. Excellent verbal and written communication skills and interpersonal skills are required. Experience with relational database design, general knowledge of FDA regulations and with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA is also required. Must have excellent communication, problem solving and people/project leadership skills. * For application attention if web source is requested please use PharmaDiversity or PharmaDiversity Job Board. Pharmaceutical jobs. Biotech jobs. Healthcare jobs. Diversity jobs. PharmaDiversity. PharmaDiversity Job Board. GILEAD prefers that you apply to this job directly on their site