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Data Quality Lead

Employer
Actalent
Location
London
Salary
50.00 - 75.00 GBP/Hourly
Start date
16 Aug 2022
Closing date
24 Aug 2022

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Job Details

Description:

Develop and deliver end-to-end clinical data management in early clinical studies that establish portfolio of evidence supporting pivotal trials of medical device(s) for immunomodulation therapies. Position will work in a small company environment with cross-function teams, external investigators, Contract Research Organizations, and Core and Biomarker Laboratories.

Responsibilities:

  • Lead and manage end-to-end clinical data management across Galvani projects including
  • Electronic Case Report Form design and other clinical outcomes assessments
  • Defining and executing the Data Management Strategy including data ingestion, cleaning, and reconciliation
  • Interim and final cleaned database lock
  • Archival of all DM documents in the eTMF
  • Archival of the study database and provision of clinical data to the study site resource management,
  • Develop study data management plans and documentation in accordance with SOPs and WIs to deliver high quality, timely data deliverables to support study reporting and regulatory submissions/updates.
  • Ensure appropriate oversight of database development and data management at a CRO, including budget management, consistency in data standards across projects and studies, and lead deliverables
  • Creates study level timelines for DM deliverables
  • Lead interim data reviews and study progress reviews at study team meetings
  • Oversee and administer clinical data/document management systems including oversight of system access and management data transfers/uploads from internal and external sources including
  • DSMB reports, central laboratory, biomarkers, imaging, device logs and clinical data archiving
  • Train personnel on associated data / document management systems
  • Ensure appropriate licensing is in place for PROs/COAs and clinical dictionaries
  • Develop and manage relationships with key stakeholders e.g., CRO, Clinical Operations, Medical Monitor, Project Leader, Statistics, Field Clinical Engineers
  • Work closely with Clinical Operations personnel to maintain the company’s electronic Trial Master File (Veeva vault eTMF), which may require risk assessment of periodic release features, user acceptance testing of configuration changes, quality checking of study file completeness, study level access management
  • Participate in project teams for planning, executing, and managing the operations of complex, data intensive clinical studies, including input and review of clinical study documentation (protocol, procedures manuals, clinical study reports, charters, Monitoring plan, etc.)
  • Participate in DSMB closed sessions
  • May lead or assist clinical risk management process within study teams during liftime of the study and liaise with Device Risk Management lead to ensure appropriate clinical mitigations are applied

Requirements:

  • Minimum 5 years data management experience
  • Degree in life science 

To find out more, please contact me on 02079977220 or via email on namanuel@actalentservices.com

Job Title: Data Quality Lead

Location: London, UK

Rate/Salary: 50.00 - 75.00 GBP Hourly

Job Type: Contract

Trading as Aerotek. Allegis Group Limited, Maxis 2, Western Road, Bracknell, RG12 1RT, United Kingdom. No. 2876353. Allegis Group Limited operates as an Employment Business and Employment Agency as set out in the Conduct of Employment Agencies and Employment Businesses Regulations 2003. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, Talentis Solutions, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available at https://www.allegisgroup.com/en-gb/privacy-notices.

To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to https://www.allegisgroup.com/en-gb/privacy-notices.

We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice at https://www.allegisgroup.com/en-gb/privacy-notices for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield

Company

About Actalent

Actalent connects passion with purpose. Our scalable services and talent solutions drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world.

 

Actalent’s global footprint and flexible delivery models ensure access to specialized talent where and when you need it. We promote consultant engagement through professional development and provide experiences to ensure continuous learning. Our people are the difference.

 

Our expertise spans capabilities in engineering including product and manufacturing, systems and software, construction management, environmental, architecture and civil; and power and utilities. We focus on sciences capabilities in laboratory sciences, healthcare, and clinical research.

 

Actalent is an operating company of Allegis Group, the global leader in talent solutions.

Company info
Website
Telephone
+44 0 1344 383 100
Location
Maxis 2 ,
Western Rd
Bracknell
Berkshire
RG12 1RT
GB

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