Serve as the subject matter expert for the planning, set-up, and acquisition of external clinical data at the study level and manage study start up, conduct and close out activities.
Create external data transfer agreements, ensuring external clinical trial data are aligned with company Standards and specifications to support data integration, analysis, and reporting.
Help and advice in setting up infrastructure for external data, to flow into company Clinical data pipelines.
Responsible for validation of all 3rd Party Data generated in clinical trial into company Clinical Data pipelines.
Develop strong and productive working relationships with key stakeholders like Clinical Data Management, Clinical Data Engineering, Standards and other Study Execution Team members.
Participate in preparing function for submission readiness and may represent Clinical Trial Tools & Technologies (CT3) group in a formal inspection or audit.
Representing company in interactions with key external partners as part of company CT3 3rd Party Data Acquisition team.
Responsible for timely submission and on-going maintenance of study related 3rd Party Data Acquisition documentation in TMF.
Follow procedural documents and participating in reviewing and updating documents to make sure they are reflective of industry standards and regulatory requirements and include optimal processes.
Follow procedural documents and participating in reviewing and updating documents to make sure they are reflective of industry standards and regulatory requirements and include optimal processes.
Escalate issues to CT3 leadership appropriately.
REQUIREMENTS:
Master's degree in public administration in Epidemiology and Biostatistics or related discipline.
24 months experience as Clinical Data Manager, Statistician, Biostatistician or related occupation.
Must also have experience with at least one of the following areas/technologies also required: Clinical Data Capture: Medidata Rave, Sitero, Medrio, Phase Forward InForm
Data Analysis: SAS or similar technologies.
Email resume to: hr.us@acldigital.com
Posted on: 9/9/2026
Numbers & Facts
Location
King of Prussia, PA
Skills
Biostatisticsunmatched
Clinical Dataunmatched
Clinical Data Managementunmatched
Clinical Trialunmatched
Data Analysisunmatched
Data Collectionunmatched
Data Managementunmatched
Documentationunmatched
Epidemiologyunmatched
Public Administrationunmatched
Startupunmatched
Statistical Analysis System (SAS)unmatched
Time Managementunmatched
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