Senior Clinical Programmer, Clinical Data Management
WE CAN OFFER YOU:
- The chance to join a successful and growing organization with an unmatched leadership team, passionate about their employees.
- An opportunity to make a real impact on chronic kidney disease patients with our cutting-edge therapeutics.
- A supportive, collaborative work environment, with colleagues who care about the success of the organization.
- A place that will treat you fairly, provide competitive compensation, on-going recognition, and most of all, a chance to learn, contribute and develop your skills.
- Fun, enthusiasm, support, a passion for healthy living and never a dull moment…
- Program / generate ad-hoc reports and listings in collaboration with the CRO for the Clinical Study Team (CST).
- Act as primary contact for internal departments and external vendors.
- Oversight of data management CRO/service providers on assigned studies.
- Participate in vendor evaluation, qualification, and selection, as needed.
- Participate in clinical study protocol design and review.
- Lead the CRF design/review (paper or eCRF) for assigned studies.
- Generate, review and/or approve study documents (e.g. data management plans, case report forms, data transfer specifications, SAE and/or external data reconciliation plans, coding conventions).
- Define or review Edit Check Specifications; test edit checks.
- Develop internal UAT plans, coordinate and participate in UAT for EDC as needed.
- Perform UAT based on vendor scripts (e.g., IWRS).
- Adhere to CDISC (Clinical Data Interchange Standard Consortium) utilizing CDASH guideline and best practices to facilitate creation of SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) standards.
- Execute and/or distribute data management metrics, listings, and reports.
- Monitor the progress of all data management activities on assigned studies to ensure project timelines are met.
- Provide training on the CRF completion guidelines and EDC system at the Investigators’ Meetings and to internal or external team members.
- Perform data review for quality issues and general data trends.
- Proactively identify potential study issues/risks and recommend/implement solutions.
- Review or perform external data reconciliation.
- Ensure accuracy and completeness of the clinical data collected during a clinical trial.
- Provide Data Management support to Statisticians and Statistical Programmers in production of clinical trial reports and other deliverables.
- Understand and follow SOPs.
- Review and contribute to Data Management SOPs.
- Ensure compliance with all applicable laws, regulations, and regulatory guidelines.
- Ad hoc duties as assigned.
EXPERIENCE AND SKILLS:
- Bachelor’s degree; life sciences preferred.
- Minimum 5+ years of relevant industry (sponsor and/or CRO) experience.
- Knowledge of and experience with SAS programming.
- Demonstrated knowledge of clinical data management principles, clinical trials process and regulatory requirements.
- Excellent verbal, written and interpersonal skills for working in a fast paced, cross-functional team environment.
- Good working knowledge of ICH, FDA and GCP regulations and guidelines.
- Strong well-rounded technical skills (SAS, EDC systems, MS Word, Excel, PowerPoint).
- Knowledge of industry standards (CDISC, SDTM, CDASH).
- Experience with web-based Electronic Data Capture (EDC), clinical data management systems and industry wide thesauri, such as MedDRA and WHO Drug.
- Proven ability to work both independently or in a team setting.
- Travel may comprise up to 5% of this position.
Competitive Compensation and Benefits include: Medical, Dental, and Vision Coverages, Life, AD&D, Disability, 401(k), Flexible Spending Plan, stock options. 15 vacation days per year and 11 paid holidays per year, which includes 1 floating holiday will also be provided according to company practice.
Tricida is located in South San Francisco, CA.
SEND RESUMES TO: email@example.com and indicate Job Code 110.117
Tricida is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.