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Real World Data Specialist (Clinical Data Management)
Fixed Term Contract, Surrey
 
If you have clinical operations data experience and would like to join a thriving mid-size pharma company you should consider this new vacancy.
 
Job Title: Real World Data Specialist 
Location: Surrey 
Salary: c.£34'000
Contract Term: 1 Year
 
Working with Real World Data and Consulting colleagues, you will be providing medical operations support for certain clients including protocol design, writing SOPs, set up of data collection tools, remote or on site monitoring and preparing reports. 
 
Required qualifications, experience and skills includes:
Science degree
Demonstrable experience in the clinical operations field (preferably site monitoring, data management and report writing)
Demonstrable experience of protocol and SOP design and development
A customer focused character, able to build relationships with key internal and external customers
Proven experience with clinical data management tools
 
Responsibilities will include:
 
  • Any treatment guidance/protocols or other medical documents required for the program
  • Set up of required data capture tool
  • Monitoring plan if needed
  • As the dedicated Medical Data Specialist, interact with relevant teams, Client and Pharmacists/Physicians participating in the programs on a regular 
  • Delivery of treatment guidance/protocols, data capture tools to all the Physicians and Pharmacists where applicable
  • Answers Pharmacists/Physicians questions related to treatment guidance or data capture and liaising with the program team or Client(s) team as required.  This may involve visiting sites with specific issues or even following an agreed monitoring plan.
  • Collection of all the data from patients in line with the agreed treatment guidance/protocol from the physicians/pharmacists and checking for completeness.
  • Engage with the site management coordinators in the US and the Programme Operations team in the UK in relation to data collection from the sites.
  • Preparation of any required status reports on the data from the program including reports required by regulatory agencies where applicable.
  • Transfer of the Adverse Event findings which are described in the forms to the client's Pharmacovigilance Department, or alternatively to the company Pharmacovigilance responsible person.
  • Work with the Medical Affairs Team to ensure all enquiries are efficiently and accurately addressed
  • Support the MI and Quality departments in the event of a recall or quality complaint.
  • Adhere to regulatory, quality and compliance guidelines and appropriate level of SOP competence measured against company quality standards.
  • At the end of a MAP program ensure the following are completed
  • All data are collected from sites
  • All agreed reports are drafted and reviewed as agreed with the client

To learn more about this role, please apply or contact Lorna directly on lorna.plowright@bluepelican.com

How to apply

If this position is of interest please send us your CV here, or you can call Lorna Plowright direct on to discuss this and other vacancies that may suit.

Lorna Plowright

Email: lorna.plowright@bluepelican.com