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.
