Overview
On Site
Full Time
Skills
Acquisition
Startups
Data Integration
Reporting
Data Flow
Clinical Data Management
Data Engineering
Clinical Trials
Auditing
Documentation
Regulatory Compliance
Leadership
Quality Control
Data Acquisition
Management
Negotiations
Collaboration
Supervision
FTP
CDMS
Veeva
TMF
Job Details
Roles & Responsibilities:
Technical/Functional Expertise:
- Serve as the subject matter expert for planning, setup, and acquisition of external clinical data at the study level, managing study startup, conduct, and closeout activities.
- Create external data transfer agreements, ensuring alignment with company standards and specifications to support data integration, analysis, and reporting.
- Provide guidance in setting up infrastructure for external data flow into company clinical data pipelines.
- Oversee the validation of all third-party data generated in clinical trials, ensuring accurate integration into company clinical data pipelines.
- Develop strong and productive working relationships with key stakeholders, including Clinical Data Management, Clinical Data Engineering, Standards, and other Study Execution Team members.
- Support submission readiness efforts and may represent the Clinical Trial Tools & Technologies (CT3) group in formal inspections or audits.
- Represent the company in interactions with key external partners as part of the CT3 Third-Party Data Acquisition team.
- Ensure timely submission and ongoing maintenance of study-related third-party data acquisition documentation in the Trial Master File (TMF).
- dhere to procedural documents and participate in their review and updates to ensure compliance with industry standards, regulatory requirements, and best practices.
- Collaborate with and review work delivered by external partners (e.g., laboratories, eCOA providers, technology providers) performing services on behalf of the company.
- Escalate issues to CT3 leadership as needed.
Technical/Functional Expertise:
- Strong working knowledge of FDA and ICH regulations, industry standards, and quality control principles.
- Experience across all phases of drug development.
- Extensive experience in clinical data acquisition and management from external/third-party vendors.
- bility to lead study-level negotiations and agreements for data transfer or integration on behalf of the company.
- Strong collaboration skills, with the ability to work effectively across all levels of the organization with moderate supervision.
- Familiarity with FTP tools like GlobalScape and clinical platforms such as Veeva CDMS, Elluminate, and Veeva TMF is a plus.
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