General Information

Location: Bala Cynwyd, PA

Organization: ACI Clinical

Job Type: Full Time

Description and Requirements

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.  
  
Responsibilities:   

  • 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  

 
Requirements:   
  • 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.  

ABOUT US:

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.