Data Integration/Clinical Data Standards Expert – Ambitious Top Pharma - $110k - $180k

Data Integration/Clinical Data Standards– Clinical Operations – Ambitious Top Pharma - $110k - $180k + Benefits – Bergen County, New Jersey

Suitable for: Data Systems Manager, Data Standards Expert, Data Integration, Data Specialist, Clinical Data

Data Integration/Clinical Data Standards Expert - $130k - $180k – Bergen County, New Jersey

Company Information

Now is an incredibly exciting time to join this organisation who have several roles at varying levels, they already have one arm of their business established within the industry and based all around the world, they are now working on the second arm to their business. You have the benefit of the security and financial backing of a global leading business, however the feel of a start up and close knit team who work collaboratively. The company has a significant presence in branded generics markets across emerging economies, with presence across 20 countries, 16 manufacturing facilities in 5 countries and 6 R&D centres dedicated to the goal of enriching lives around the world. Currently employing over 11,000 people from around 50 nationalities they strongly believe their work force is the driving force behind the success of the organization.

Data Integration/Clinical Data Standards - $130k - $175k – Bergen County, New Jersey

Please contact Emily O’Brien on 646-569-9081 or if you would like to know more about this opportunity. This will be 100% confidential.

Position Summary

Provide experienced standard and regulatory compliant insight to Clinical Development Plans, Clinical Study Protocols and Clinical Study Reports across the Innovative and Approved products. You should be able to “think with the end of mind” to ensure the compliance in terms of data collection and presentation to support regulatory dossier submission.


* Accountable for ensuring that submission datasets are conforming to the data standards required by regulatory agencies

* Lead the collaboration between relevant functions to produce compliant datasets for regulatory submissions

* Maintain Knowledge of regulatory developments related to data standardization, follow the latest submissions requirements for agencies

* Participate in standards-related process improvement meetings and workshops

Required Skills

* Experience of preparing, reviewing and submitting CDISC compliant datasets to the regulatory agencies

* Experience overseeing CRO activities

* Experience in standardisation of clinical collections and submissions modules

Please contact Emily O’Brien on 646-569-9081 or if you would like to know more about this opportunity. This will be 100% confidential.


Key Words: CDISC, SDTM, ADaM, SAS, Statistical, Programming, Data Standards, Datasets, Pharmaceutical, USA, New Jersey, NJ, Bergen County