Clinical Data Acquisition Specialist
16 hours ago
We are seeking a highly skilled Clinical Data Acquisition Specialist to join our team at Maxis Clinical Sciences. As a key member of our Clinical Trial Tools & Technologies (CT3) group, you will be responsible for planning, setting up, and acquiring external clinical data at the study level.
Key Responsibilities:
- Develop and maintain strong relationships with key stakeholders, including Clinical Data Management, Clinical Data Engineering, and other Study Execution Team members.
- Participate in preparing the function for submission readiness and represent the CT3 group in formal inspections or audits.
- Represent the client in interactions with external partners as part of the CT3 3rd Party Data Acquisition team.
- Responsible for timely submission and ongoing maintenance of study-related 3rd Party Data Acquisition documentation in the Trial Master File (TMF).
- Liaise with and review work delivered by external partners, such as laboratories, eCOA providers, and technology providers.
- Escalate issues to CT3 leadership as needed.
Requirements:
- Working knowledge and understanding 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.
- May lead study-level negotiation and agreement for data transfer or integration on behalf of the client.
About Maxis Clinical Sciences:
Maxis Clinical Sciences provides complete solutions for clinical and digital services. With a global presence and a team of 200+ techno-functional domain experts, we offer a range of services, including clinical data management, clinical analytics, patient-centric technology enablement services, and more.
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