clinical data Specialist

Serving as the subject matter expert for the planning, set-up, and acquisition of external clinical data at the study level, managing study start up, conduct and close out activities.

· Creating external data transfer agreements, ensuring external clinical trial data are in alignment with the Takeda Standards and specifications to support data integration, analysis, and reporting.

· Help and advice in setting up infrastructure for external data, to flow into Takeda Clinical data pipelines.

· Responsible for validation of all 3rd Party Data generated in clinical trial into Takeda Clinical Data pipelines.

· Developing strong and productive working relationships with key stakeholders like Clinical Data Management, Clinical Data Engineering, Standards and other Study Execution Team members.

· Participates in preparing function for submission readiness and may represent Clinical Trial Tools & Technologies (CT3) group in a formal inspection or audit.

· Representing Takeda in interactions with key external partners as part of Takeda CT3 3rd Party Data Acquisition team

· Responsible for timely submission and on-going maintenance of study related 3rd Party Data Acquisition documentation in TMF

· Following 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.

· Liaising with and reviewing work delivered by external partners (e.g. laboratories, eCOA providers, technology providers, etc.) performing services on behalf of Takeda.

· Escalating issues to CT3 leadership appropriately

Technical/Functional Expertise

· Working knowledge and understanding of FDA and ICH regulations and industry standards and quality control principles.

· Experience with all phases of drug development.

· Solid Experience in handling Clinical data acquisition and management from external/3rd Party vendors

· May lead study level negotiation and agreement for data transfer or integration on behalf of Takeda.

· should be able to function collaboratively (with some guidance) with all levels of employees , moderate supervision required

· Knowledge on FTP tools like GlobalScape, Clinical platforms like Veeva CDMS, Elluminate and Veeva TMF will be a plus.

Job Types: Full-time, Contract

Pay: $12,000.00 - $12,500.00 per year

Schedule:

• 8 hour shift

Experience:

• HEDIS: 1 year (Preferred)

License/Certification:

• Epic Certification (Preferred)

Ability to Commute:

• Boston, MA 02114 (Required)

Ability to Relocate:

• Boston, MA 02114: Relocate before starting work (Required)

Work Location: In person

Salary : $12,000 - $12,500