Data Acquisition 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 client Standards and specifications to support data integration, analysis, and reporting.
• Help and advice in setting up infrastructure for external data, to flow into client Clinical data pipelines.
• Responsible for validation of all 3rd Party Data generated in clinical trial into client 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 client in interactions with key external partners as part of client 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 client.
• 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 Client.
• 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 Type: Full-time

Pay: $27.53 - $33.16 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Ability to Relocate:

• Lexington, MA 02421: Relocate before starting work (Required)

Work Location: Hybrid remote in Lexington, MA 02421