Principal Clinical Programmer

Smart, hard working and friendly team (aka family); opportunities for growth and development; flexible hours and fully remote work

• Acts as the Clinical programming program leader by ensuring consistency between studies for a sponsor, monitoring study timelines, evaluating, and mitigating project risks and reporting/reconciling project budgets.
• May act as the Lead Clinical Programmer for one or multiple studies.
• Attend capability and defense presentations with clients to support the development of new business
• Provide regular status updates and keep the team and management informed of any changes.
• Work with management and senior clinical programming/DM personnel to implement technical solutions and resolve issues.
• Complete Clinical programmer tasks for assigned studies under minimal supervision according to the study contract and applicable SOPs.
• Design, develop, implement, maintain, and support clinical database systems.
• Offer technical expertise for internal and external clients.
• Code, test, and document databases as per programming standards and clinical validation policies.
• Program database manipulation and conduct data transfers for clients.
• Review Data Validation Plans and Case Report Forms as per area of expertise.
• Add all external data sources such as PK and central lab within the clinical database if integration is requested or required.
• Serve as programming contact to handle database issues within area of expertise.
• Support development and implementation of new technologies.
• Support Information Technology to evaluate new technology upgrades by participating in software change controls.
• Support development, revision and maintenance of core operating procedures and working instructions pertaining to database development, user acceptance testing and change controls
• Interface with project team to organize responsibilities and deliverables.
• Establish effective communication and professional relationships with teams and external vendors.
• Interface with Clinical Data Management and corporate team to negotiate timelines.
• Perform administrative tasks within the EDC system, such as site and user management, URL level reviews and/or approvals, and dictionary updates.
• Follow and influence the development of data standards and strategies pertaining to the standards library

• Minimum BS in a scientific or health related field or equivalent in years of experience.
• Minimum 10 years of experience as a clinical database developer with at least 5 years of experience leading a study build.
• Excellent programming skills in SAS and R, including designing and developing output tables, listings, and figures.
• Experience with EDC systems, such as Medidata Rave, InForm, Medrio, Veeva, IBM.
• Understanding of the principles of ICH GCP and regulatory requirements is essential.
• Excellent organizational and analytical skills, strong oral and written communication skills, and able to work in a high paced, timeline driven setting.

All your information will be kept confidential according to EEO guidelines.