What are the responsibilities and job description for the Clinical Data Manager position at Katalyst Healthcares & Life Sciences?
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.
