Data Entry jobs in United Kingdom

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The Senior Data Manager ensures data management tasks for assigned studies are performed on time and within budget. They partner with Sponsors, clinical teams, and statisticians to develop data collection specifications from all data sources.

The Senior Data Manager manages in-stream data flow activities, delivers a quality database according to the project plan, leads the data management team, and acts as the primary contact for the Sponsor and the project’s data management responsibilities.

The Senior Data Manager ensures data management tasks for the assigned studies are performed on time and within budget. They partner with Sponsors, clinical, and statistics teams to develop data collection specifications from all data sources. They manage in-stream data flow activities, deliver a quality database in accordance with the project plan, lead the DM team, and serve as the reference point for the Sponsor and the project from a data management perspective.

• Drive achievement of project milestones from study start-up through database delivery.
• Provide data management input into the protocol.
• Design the Case Record Form (CRF) and guide the CRF approval process.
• Define and develop the Data Management Plan, Data Validation Plan, and annexes (e.g., Reconciliation Plan), with input from the study team.
• Validate the database and perform computerized checks, including SAS listings or checks.
• Define the User Acceptance Test (UAT) Plan for EDC studies and execute testing to ensure quality eCRF.
• Respond timely to issues identified by the eCRF Helpdesk.
• Prepare CRF completion guidelines and data-entry guidelines; train data-entry staff.
• Perform term coding, raise manual queries for uncoded terms, and manage query resolution.
• Create and test import programs for external data.
• Perform data reconciliation and integration of CRF and non-CRF data.
• Monitor study data progress, manage queries, escalate issues, and ensure data quality.
• Lead the DM team, assign work, schedule, prioritize, and monitor progress.
• Contribute to training and follow SOPs, industry standards (ICH, GCP).
• Recommend process improvements and develop new standards.
• Maintain communication with the study team and sponsor, represent Data Management in meetings.
• Perform other activities as required.

• Degree in life sciences, pharmacy, biology, or related field, or at least 5 years of experience in data management in pharma.
• Knowledge of Data Management processes and industry guidelines (ICH, GCP).
• Experience in oncology and early-phase studies.
• Proficiency in Medidata RAVE EDC.

• English proficiency, good MS Office skills.
• Trustworthy, quality-focused, personable, willing to learn, team player.
• Effective stress management, learning agility, conflict management, problem-solving, communication, networking skills.

Bachelor of Science in Biology, Life Sciences, or Pharmacy.

Regular, Full-time.

• Verona-Remote; Bologna-Remote; Verona; Milan; Bologna; Padova-Remote; Padova; Milan-Remote