3rd Party Data Acquisition Lead

Maxisit - Lexington, MA

Full-time - Mid Level

Remote - Lexington, MA

Repair and Maintenance

About the position

The 3rd Party Data Acquisition Lead is responsible for overseeing the planning, setup, and acquisition of external clinical data at the study level. This role involves managing study startup, conduct, and closeout activities, ensuring that external clinical trial data aligns with client standards and specifications. The lead will also validate all 3rd party data generated in clinical trials and develop strong relationships with key stakeholders to facilitate effective data integration and reporting.

Responsibilities

• Serve as the subject matter expert for planning, setup, and acquisition of external clinical data at the study level.
• Manage study startup, conduct, and closeout activities.
• Create external data transfer agreements and ensure alignment with client standards.
• Assist in setting up infrastructure for external data flow into client clinical data pipelines.
• Validate all 3rd party data generated in clinical trials into client clinical data pipelines.
• Develop strong working relationships with stakeholders like Clinical Data Management and Clinical Data Engineering.
• Participate in submission readiness and represent the CT3 group in inspections or audits.
• Represent the client in interactions with key external partners as part of the CT3 3rd Party Data Acquisition team.
• Ensure timely submission and maintenance of study-related 3rd Party Data Acquisition documentation in TMF.
• Review and update procedural documents to reflect industry standards and regulatory requirements.
• Liaise with and review work delivered by external partners performing services on behalf of the client.
• Escalate issues to CT3 leadership appropriately.

Requirements

• Working knowledge of FDA and ICH regulations and industry standards.
• Experience with all phases of drug development.
• Solid experience in handling clinical data acquisition and management from external/3rd party vendors.
• Ability to lead study-level negotiations and agreements for data transfer or integration.
• Collaborative functioning with all levels of employees, requiring moderate supervision.
• Knowledge of FTP tools like GlobalScape and clinical platforms like Veeva CDMS, Elluminate, and Veeva TMF is a plus.

Benefits

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance