Clinical Data manager

Overview

Remote
Depends on Experience
Accepts corp to corp applications
Contract - Independent
Contract - W2

Skills

Data Acquisition
DTAs
vendor relations
Clinical Data pipelines
CDMS
Veeva
3rd Party Data Acquisition
FTP

Job Details

Need stronger with working on Data Acquisition, DTAs and vendor relations.

Responsibilities:

  • 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.

Technical/Functional Expertise:

  • 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.

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