SEC Recruitment

Contract Clinical Data Manager

£40 - £41 per hour
05 Sep 2019
03 Oct 2019
Priya Mukherjee
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Main responsibilities include:

* Support the set up and management of the EDC system and database.
* Support the database design and testing (UAT), using specialist clinical database applications
*Support the development of the edit checks both manual and coded (e.g. using Java Script)
* Support the development of protocols, plans, Standard Operating Procedures (SOP's) and processes as required identifying areas for process improvement as appropriate
* Upload study data to a variety of clinical and non-clinical databases and ensure ongoing timely data capture and data cleaning of all data sources
* Monitor data quality and integrity.
* Work closely with clients as a point of contact/troubleshooter for any data issues
* Ensure study timelines are met and data quality is according to high industry standards
* Oversee the issuing of queries and review query responses
* Ensure all database modifications are communicated with the team and implemented effectively
* Ensure adherence to GCP, regulatory guidelines, standard processes and SOPs
* Generate data analysis status reports on clinical studies for the clinical study teams as required
* Lock, transfer and archive databases
* Manage client relationships and foster client engagement, maintaining good links to help generate new/repeat business

Interested applicants will hold:

* A BSc/MSc (or equivalent) in life sciences, statistics or a related subject or industry equivalent experience
* Proven data management expertise and a sound working knowledge of the data management process
* Solid knowledge of clinical trial database technologies and processes
* Proven experience working within the pharmaceutical/clinical trials industry
* Good understanding of Good Clinical Practices and relevant regulatory guidelines
* Ability to work collaboratively on multi-disciplinary project teams and proactively manage relationships with other
* Significant experience in clinical data management across Phase I-IV.
* Good project management, planning, risk, organisational and communication skills
* Excellent written and verbal English
* Excellent accuracy and attention to detail
* Excellent computer literacy, including strong Microsoft Office skills (excel, word, power-point, project)