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Hi,
I am Rakesh from Anveta. I am trying to reach you for Job opportunity for 3rd Party Data Acquisition Lead at Remote.
Please share me below detail for quick submission along with resume.
Work authorization:
Current location::
Local DL:
LinkedIn Id:
Must have Veeva CDMS, clinical Trail exp
Must have pharmaceutical exp
3rd Party Data Acquisition Lead
Remote
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:
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.
Thanks & Regards,
Email is the best way to reach Me!!!
Rakesh Jaiswal
Technical Recruiter
Direct: 4694980074
Anveta Inc.
Email: [email protected] l URL: http://www.anveta.com
Address: 1333 Corporate Drive, Suite #108 Irving, TX 75038, USA
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