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Real World Data Manager

5 months ago

United Kingdom Verbatim Pharma Full time

We are seeking a Data Manager to focus on Real World Data for Early Access projects. This role involves partnering with clients and internal stakeholders to provide practical support and implement real-world data collection projects within the early access/named patient/compassionate use setting.

Responsibilities

  • Act as the main point of contact for clients regarding real-world data.
  • Lead the scoping and delivery of real-world data projects.
  • Participate in proposal development and project kick-off meetings to guide and define data collection strategies.
  • Provide oversight of all data management activities, including project design, set-up, and implementation.
  • Develop core project documents for data management, such as Data Management Plans (DMPs), Data Validation Plans (DVPs), and Case Report Form (CRF) completion guidelines.
  • Work closely with the Technical Operations team to design data collection solutions that meet individual client requirements.
  • Lead the design and validation of CRF specifications and edit checks for electronic data capture (EDC) systems.
  • Create and test study databases according to client specifications.
  • Partner with EDC vendors to ensure data projects are built on time and accurately reflect client requirements.
  • Monitor and review all data submitted via internal and external platforms to support real-world data projects.
  • Ensure real-time data management and maintain overall data quality and completeness.
  • Conduct data reviews, identify data issues, and generate queries as needed.
  • Undertake data cleansing and descriptive data analysis at agreed frequencies with clients.
  • Provide expert insight into developing and enhancing real-world data offerings.

Qualifications

  • Previous experience working as a data manager with Clinical trial / Real World Data experience is essential
  • Strong proficiency with EDC platforms for clinical data collection.
  • Deep understanding of data management processes and standards.
  • Experience attending client calls and being comfortable being client facing
  • Experience in analysing and processing clinical study data.
  • Experience in working with international organizations and multicultural environments.
  • Proactive team player with excellent communication skills.

Ideally you will be able to commute to Slough area to attend the office on a hybrid basis however if you are further away then remote could be open to consideration.