Manager, Clinical Programming
Employment Type: Full-Time
Industry: Scientific Research
ACI Clinical is searching for a Manager, Clinical Programming. In this role, the person selected will lead and manage programming activities for ongoing projects that require Adjudication of Endpoints.
- Collaborate with Clinical, Data Management and Project Management teams to help support by providing programming support for adjudication of endpoints/outcome events
- Discuss with Clinical trial leaders and develop strategies for identification of endpoints defined in the Charter/Protocol documents
- Author specifications as per the charter-defined event identification strategy for programmatic identification of events as per the charter definition.
- Lead and Manage Endpoint Adjudication programming activities that include dataset specification, development, generation & validation of datasets, Summaries, Patient profiles and Data listings for ongoing clinical trials
- Develop data transfer documents for active studies and lead exchange of clinical and adjudicated data between vendors/CROs/sponsors
- Develop customized graphical displays as per the statistical analysis plan/charter, perform data integrity checks and ensure correctness of data displays.
- Manage multiple projects and develop global tools to improve programming efficiency and quality
- Responsible for creating documentation through specification development, programming and validation for future reference and for internal control purposes.
- Perform exploratory programming for statistical analysis and ad hoc analysis
- 10+ years of SAS programming experience supporting analysis and reporting for Phase I / Phase II, Phase III and Phase IV clinical trials data.
- Experience in mapping clinical study data to standard/submission/repository data models and programming experience converting raw data to the data models.
- Programming experience supporting Oncology, Cardiovascular, CNS, Infectious disease and device related studies.
- Proven experience in developing data transfer documents and leading exchange of clinical data between vendors/CROs/sponsors.
- Strong Base SAS and SAS Macro programming skills.
- Proven skills in the development and review of SAS programs, macros/utilities, debug macros within a clinical trials environment.
- Proven experience in developing programs to check adjudicated data quality, ensure consistency and compliance to CDISC data guidelines, data transfer agreements.
- Ability to develop programs converting raw data to standard format as per the business rules.
- Generate Flat files - Delimited Text/Excel files/ODS, summaries, graphs, listings, narratives and reconciliation outputs for ongoing clinical trials.
- Provide technical support and guidance to the internal team mentoring junior programming members.
- Prior experience in authoring Training documents, work instructions, guidelines and SOPs.
- Excellent communication skill and problem-solving abilities.
ACI Clinical, a member of the WCG Clinical family, is a specialty provider of clinical trial committees and clinical trial advisory services. ACI maintains deep involvement in several public-private thought leadership efforts to improve the quality and effectiveness of clinical trials by enhancing data integrity for regulators and the scientific community to drive efficiencies in clinical research and enable more informed decision-making.
WCG is proud to be an equal opportunity employer Qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, sexual orientation, gender identity, age, marital status, disability, veteran status or any other status protected by law.
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Associated topics: clinical, clinical development, clinical informatics, clinical trial, coordinator, lab, laboratory, research, research coordinator
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