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32 FCS Software Solutions Jobs

Data Acquisition Lead (FSP)

8-12 years

Noida

1 vacancy

Data Acquisition Lead (FSP)

FCS Software Solutions

posted 1d ago

Job Description

Role: Data Acquisition Lead (FSP)

Duration: Contract

Location: Remote

Work timing: IST or UK Hours


Job Description:


- 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:

Abhinav Krishna Srivastava

Mob : +91- 9667680709

FCS Software Solutions Ltd.

Email: asrivastava@fcsltd.com



Employment Type: Full Time, Temporary/Contractual

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What people at FCS Software Solutions are saying

What FCS Software Solutions employees are saying about work life

based on 142 employees
61%
81%
75%
57%
Flexible timing
Monday to Friday
No travel
Day Shift
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FCS Software Solutions Benefits

Cafeteria
Team Outings
Health Insurance
Free Transport
Soft Skill Training
Job Training +6 more
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