Job Title: 3rd Party Data Acquisition Lead (FSP)
Client: Takeda
Location: Candidate must be on the East Coast
Onsite/Remote: Remote
Duration: 9+ Months
Visa: USC, GC
Must have fantastic communication skills and able to take a video screen with me today.
3rd Party Data Acquisition Lead (FSP) Role Profile
- Serve as the subject matter expert for the planning, set-up, and acquisition of external clinical data at the study level and manage study start up, conduct, and close out activities.
- Create external data transfer agreements, ensuring external clinical trial data are in alignment with company Standards and specifications to support data integration, analysis, and reporting.
- Help and advice in setting up infrastructure for external data, to flow into company Clinical data pipelines.
- Responsible for validation of all 3rd Party Data generated in clinical trial into company Clinical Data pipelines.
- Develop strong and productive working relationships with key stakeholders like Clinical Data Management, Clinical Data Engineering, Standards, and other Study Execution Team members.
- Participate in preparing function for submission readiness and may represent Clinical Trial Tools & Technologies (CT3) group in a formal inspection or audit.
- Representing company in interactions with key external partners as part of company CT3 3rd Party Data Acquisition team.
- Responsible for timely submission and on-going maintenance of study related 3rd Party Data Acquisition documentation in TMF.
- Follow 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.
- Liaise with and reviewing work delivered by external partners (e.g., laboratories, eCOA providers, technology providers, etc.) performing services on behalf of company.
- Escalate 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 company.
- 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.