Lead Data Manager

Lead Data Manager
Alderley Park

Are you seeking your next challenge as a Lead Data Manager? Want to help drive the growth and development of a data management department to support the commercial success of an innovative and forward-thinking business? If so, we want to hear from you.

The Company:

Aptus Clinical supports life science companies and academia in their quest to identify and develop valuable new medicines. We have a passion for drug development and a belief in the power of collective knowledge and collaboration.

This is a fantastic opportunity to join us as our Lead Data Manager and shape the development of the data management processes and capability on behalf of the company.

The Benefits:

– Competitive salary
– Company performance-based bonus
– On-site parking
– Pension
– Holiday benefit is 22 days’ holiday (rising to 25 days with service)

Once you join our team, you’ll discover a fast-growing and exciting company where we combine expertise and close partnership to deliver the right outcome for our clients.

Based in an open plan office, we foster an informal and fun, yet fast-paced environment. We believe that by bringing talented people together, we can deliver ground-breaking innovations to the world of medicine.

So, if you think you’d thrive with a pioneering business that supports personal growth and development, this is the role for you.

The Role: 

As our Lead Data Manager you will be accepting this exciting opportunity to lead the development of our data management capability and processes to ensure the quality, control and timeliness of all data management deliverables for the clinical trials being delivered on behalf of the business.  As a key member of the clinical study team, you will establish, perform and oversee the setup, maintenance, control, cleaning and validation of clinical study databases ensuring compliance with Standard Operating Procedures and applicable regulatory guidelines at all times

Specifically, you will:

  • Lead the development of the Data Management function and processes on behalf of Aptus Clinical
  • Define and manage clinical data management timelines on multiple studies or programmes
  • Coordinate/perform all CDM activities for assigned studies/programmes, including eCRF design, EDC system set up, user acceptance testing, users training, data review, query generation and data coding
  • Prepare data management plans, data validation plans and other study specific procedures and guidelines in compliance with standard processes and SOPs
  • Ensure appropriate study specific training is provided to assigned study teams and documented
  • Generate data analysis status reports on clinical studies for the clinical study teams

About You: 

To join us as our Lead Data Manager, you’ll need:

  • A scientific background, ideally university level and GCP trained
  • A minimum of 5 years’ experience in clinical data management with strong experience using major EDC systems and related tools and technologies
  • Experience in leading data management studies and teams to timely delivery of quality databases that meet regulatory requirements
  • Sound working knowledge of programming languages utilised in data management (e.g. javascript, SQL)
  • Knowledge and experience of using CDISC standards such as SDTM, CDASH, Controlled terminology and define.xml
  • Good planning, organisational and communication skills
  • Excellent written and verbal English
  • Excellent attention to detail
  • Ideally experience of using Viedoc EDC

Additionally, to be considered for our Lead Data Manager position, you will ideally have experience of using Viedoc EDC.

If you have the talents we’re looking for, this could be your chance to join our rapidly growing company.

Please note we do not accept applications from agencies and you must be eligible to live and work in the UK.

To apply, please attach your CV and quote job reference JMC/LDM.

If we think you’ve got potential, we’ll be in touch within 10 working days.

So, if you’re seeking your next challenge as a Lead Data Manager, please apply by emailing your CV to contact@aptusclinical.com.