Description
A pharmaceutical provider within the San Francisco Bay area is now recruiting for a Senior Clinical Programmer.The senior clinical programmer will provide clinical programming support for assigned studies. The senior clinical programmer will also be responsible for program listing and reports and the generation of program specifications, as well as being responsible for performing system setup and/or User Acceptance Testing following standard process procedure and SOP.
Responsibilities
- Responsible for in-depth knowledge of assigned studies' protocols, CRFs, clinical and external data structure and content, study timelines and key milestones
- Proactively ensure all data transfers are scheduled and multiple data sources coordinated if necessary to support the reporting needs of assigned studies.
- Ensure specifications are in place for all data transfers, verification of data against data transfer specs, reconciliation of external data with clinical data, clinical data review deliverables, including patient profiles and BOXI reports, and study metrics deliverables:
- Review routine specifications drafted by support programmers or study team members, revise if needed with input from team
- Ensure end users have sufficient detail (QC listings, support data presentation) in addition to the formal deliverables to evaluate them for approval
- Maintain change logs as specifications are revised or updated
- Manage the Clinical Programming queue of work from request to release: Send reviewed/completed specifications for programming
- Ensure support programmers (in-house or CRO) meet timelines, or escalate any at risk
- Orients support programmers to the study and to Onyx systems and processes
- Provides responsive programming support for any tight-timeline, ad hoc, or crucial deliverables or data transfers, and for quick turnaround code fixes to facilitate release
- Provides support in development and implementation of improved clinical programming processes, SOPs, methods, and deliverables
Required Education and Experience
- Bachelor in Computer Sciences, Mathematics, Life Sciences with a minimum of 5 - 8 years of clinical or statistical programming experience in the pharmaceutical or biotechnology industry, or MA/MS with 4 years of experience
- Proven Clinical programmer experience in a pharmaceutical or CRO working in a FDA regulated environment
- Experience in EDC systems, data management preferred
- Experience in project management
Compensation
This healthcare provider is very eager to hire and encourages all interested applicants to apply as soon as possible. This is a 1 year contract, with potential for extension or conversion. Do not hesitate to apply today.