Clinical Data Manager
Apply NowCompany: Katalyst HealthCares and Life Sciences
Location: South Plainfield, NJ 07080
Description:
Responsibilities:
Requirements:
- Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities.
- Assist in creating external data transfer agreements, ensuring alignment with Takeda Standards and specifications to support data integration, analysis, and reporting.
- Provide support in setting up infrastructure for external data to flow into Takeda Clinical data pipelines.
- Assist in validation of all 3rd Party Data generated in clinical trials into Takeda Clinical Data pipelines.
- Develop and maintain working relationships with key stakeholders like Clinical Data Management, Clinical Data Engineering, Standards, and other Study Execution Team members.
- Assist in preparing function for submission readiness and may support Clinical Trial Tools & Technologies (CT3) group in formal inspections or audits.
- Act as a representative for Takeda in interactions with key external partners as part of the Takeda CT3 3rd Party Data Acquisition team.
- Support timely submission and ongoing maintenance of study-related 3rd Party Data Acquisition documentation in TMF.
- Follow procedural documents and assist in reviewing and updating documents to ensure they reflect industry standards and regulatory requirements and include optimal processes.
- Assist in liaising with and reviewing work delivered by external partners (e.g., laboratories, eCOA providers, technology providers) performing services on behalf of Takeda.
- Escalate issues to CT3 leadership as appropriate.
Requirements:
- Develop working knowledge and understanding of FDA and ICH regulations and industry standards and quality control principles.
- Gain exposure to all phases of drug development.
- Assist in handling Clinical data acquisition and management from external/3rd Party vendors.
- May support study-level negotiation and agreement for data transfer or integration on behalf of Takeda.
- Collaborate with all levels of employees with moderate supervision required.
- Familiarity with FTP tools like GlobalSCAPE, Clinical platforms like Veeva CDMS, Elluminate, and Veeva TMF will be beneficial.