Data Manager Consultant

This is a fully remote position, open to applicants in Europe.

📋 Description

• Oversee data management tasks for clinical trials, which encompass database establishment, study execution, and conclusion.

• Ensure that study deliverables adhere to timelines and meet quality benchmarks.

• Work in collaboration with cross-functional teams to uphold project schedules and deliver high-caliber data management outputs.

• Examine clinical research documents, including protocols and Case Report Forms.

• Generate and assess specifications for electronic Case Report Forms.

• Formulate Data Management Plans, Data Validation Plans, eCRF Completion Guidelines, Data Entry Guidelines, and Data Review Plans.

• Create edit rules/checks, query logic, and query messages.

• Develop User Acceptance Testing Plans and evaluate data entry interfaces and edit checks.

• Design and deliver training sessions for clinical teams and sites.

• Conduct ongoing data review and reconciliation processes, providing metrics and patient trackers.

• Execute database lock/unlock and freeze/unfreeze procedures for statistical evaluations, interim analyses, and final database locks.

• Manage the archiving of study databases and associated documents.

• Draft Data Transfer Specifications and perform reconciliation with external vendors.

• Conduct SAE reconciliation.

• Enhance and sustain client satisfaction through exceptional service, communication, and clinical data management.

⛳️ Requirements

• A Bachelor’s degree in clinical, pharmacy, biological, mathematical sciences, a related discipline, or a nursing qualification.

• A minimum of 3 years of data management and/or related experience within the pharmaceutical sector.

• Proficient understanding of clinical research, clinical trial methodologies, relevant regulatory standards, and terminology.

• Strong expertise with various electronic data capture systems, such as Medidata Rave, Oracle InForm, OpenClinica, and Medrio.

• Execute responsibilities in accordance with SOPs, GCP, and ICH guidelines.

• Capability to prioritize tasks and adapt swiftly in a dynamic, fast-paced industry environment.

• Ability to independently lead a study or data management team.

• Drive quality and efficiency to meet deadlines and milestones, ensuring high-quality data management deliverables.

• Exceptional verbal and written communication abilities.

• Proficient in Microsoft Office Suite, including Outlook, Word, Excel, and PowerPoint.

🏝️ Benefits

• Opportunities for professional development and ongoing training.

• Promotion of work-life balance.

• A collaborative "one-team" culture.

• Commitment to equal opportunity and diversity/inclusivity.

• Prospects for career advancement.

• Initial phone interview as part of the application process.