Clincial Data Acquisition Analyst

MUST HAVES:

- 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.

Job Description:

Data Acquisition Lead Role Profile


- 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 group in a formal inspection or audit.
- Representing company in interactions with key external partners as part of company 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 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/ 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.