Clinical Documentation Administrator

Employer
Key People Limited
Location
Switzerland, Basel
Salary
£49.70 - £63.25 per hour
Closing date
23 Sep 2020

View more

Discipline
Clinical Research, Clinical Administrator
Hours
Full Time
Contract Type
Contract
You need to sign in or create an account to save a job.

Job purpose:
Senior Domain Expert for Clinical R&D Documents to support Source-to-Target Migrations of Clinical Documents. This resource will lead Migration Data Preparation activities and assist to determine all properties and attributes for Clinical Submission Documents such as Clinical Study Reports, Module 2 Documents, Clinical Safety Documents etc.

Major Accountabilities:

  • Collaborate with external vendor and NVS internal functions to build, expand and automate the migration approach for R&D (Clinical Submission, Safety) documents from Source to Target System build, expand and automate the Attribute Extraction Approach to determine mandatory document properties
  • Coordinate & oversee processes supporting extraction and migration activities by
  • Driving Quality Control activities to ensure that the migration/migration automation process is producing high-quality outputs
  • Coordinating and participating in Test Activities
  • Collaborate closely with CDGM organization and business process owners to ensure alignment of migration activities with a parallel system and/or process updates.
  • Engage with stakeholders in the Novartis organization to align on migration requirements, migration approach and missing or erroneous information in the source system

Requirements:

  • Minimum Bachelor's degree in life science/healthcare or equivalent
  • Fluent English (oral and written), German of advantage
  • Minimum 10+ years experience in LifeScience Industry
  • Extensive experience with usage of clinical document management systems
  • Working knowledge in a function exposed to R&D Documents Management (Medical Writing, Submission Management, Safety)
  • Experience with coordinating deliverables from 3rd party vendors
  • Knowledge of ICH GCP, 21 CFR part11
  • Experience with Documentum based D2LS system is a plus.
  • Experience with Document Migration Projects is a plus
  • Experience working as Business Analyst is a plus

International recruitment solutions

Key People is a truly international operation with offices in the UK, Switzerland and Iraq

We have developed working relationships with many of the FTSE 100 companies, including some of the world's most recognised global brands in the pharmaceutical, Oil, Gas, Energy and engineering industries.

Our dedication to both employers and candidates, and our vast experience enables us to provide superior solutions and effective results. We're proud to be a private company driven by our commitment to our customers and we are constantly exploring new markets in our bid to become the number one recruitment agency for customer satisfaction across a number of industry sectors.

Contact Us
  • Catherine House
  • Adelaide Street
  • St Albans
  • AL3 5BA
  • GB
  • +44 (0) 1727 811634
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert