Data Management Lead

vor 3 Wochen

Munich, Deutschland AL Solutions Vollzeit

We are hiring AL solutions are currently hiring an oncology focused biotech based in Munich

Exciting Opportunity as a Data Management Lead role.

Are you ready to take the helm as a Data Management Lead, guiding groundbreaking clinical trials to success? This dynamic role offers the chance to lead and innovate in the field of data management, ensuring that each phase of sponsored clinical trials unfolds with precision and excellence. Join our team, and let's embark on this thrilling journey together


Your Thrilling Role

  • Data Management Mastery: Seize the opportunity to oversee data management activities, channeling your expertise into all phases of sponsored clinical trials. You'll be the captain of data management, steering us to success.
  • Scope of Work Craftsmanship: Help craft the Scope of Work (SOW), shaping the future of data management deliverables and timelines, setting the stage for a remarkable journey.
  • Collaboration with Clinical Trailblazers: Collaborate closely with Clinical Trial Managers to chart timelines and ensure data management objectives are met, turning visions into reality.
  • Risk-Based Monitoring Innovation: Pioneer the way forward with your input in Risk-Based Monitoring activities, ensuring that data remains at the heart of our clinical trial success.
  • Timelines and Deliverables Leadership: Unleash your leadership by defining data management timelines, deliverables, and performance metrics. Share your vision and witness it come to life as we reach study milestones.
  • Protocol Prowess: Uncover the secrets within study protocols, ensuring they align seamlessly with data management activities. Your keen insights will guide us to victory.
  • Data Management Launchpad: Take part in the strategic planning and initiation of data management activities, including eCRF design, edit check specification, and user acceptance testing, all in close collaboration with the clinical study team.
  • Data Management Blueprint: Shape the Data Management Plan, incorporating data cleaning strategies, quality control plans, Serious Adverse Event guidelines, edit check documentation, and coding guidelines. This is your canvas for excellence.
  • Database Design Wizardry: Envision databases designed with precision, accuracy, completeness, and consistency, working closely with the lead CRO data manager. You are the architect of data integrity.
  • Quality Control Vigilance: Monitor the journey of data transferred from external vendors into the clinical database, ensuring clarity and consistency. Maintain the quality compass and initiate remediation activities when needed.
  • Trail Progress Exploration: Embark on an exciting journey of assessing and forecasting clinical trial progress through metrics and timeline management. Navigate to success and adjust course when necessary.
  • Database Freeze and Lock: Take charge of final checks for database consistency and completeness before the exhilarating moment of database freeze and lock. Safeguard the treasure of data with precision.
  • Close-Out and Archiving Adventure: Lead the charge in coordinating the thrilling close-out activities and the secure archiving of study data and data management support documents.
  • Data Management Innovation: Contribute to the dynamic landscape of data management, exploring avenues such as SOP development and data warehousing. Your ideas are the seeds of innovation.

Requirements

Your Qualifications Adventure

  • Educational Discovery: A degree in a scientific discipline or equivalent is your foundation for this thrilling journey.
  • Experience Triumph: With a minimum of 5 years' experience as a Data Manager, you're ready to lead, having managed studies from preparation through close-out, including outsourced CDM activities.
  • Independence and Communication Skills: Your ability to work independently with finesse and your exceptional written and oral communication skills set the stage for success.
  • Coding and Regulatory Mastery: Your familiarity with medication coding, medical condition coding, and Adverse Event/Serious Adverse Event handling is vital. Navigate the regulatory seas with confidence.
  • Clinical Trial Insight: A profound understanding of clinical trial methodology, data, and databases fuels your journey to success
  • Language Proficiency: Fluent in English, both written and spoken.
  • Attention to Detail: A true explorer, you are a team player with an eagle eye for detail and a passion for quality.

Benefits

This role is your ticket to an exhilarating adventure, ensuring that data management is the beacon guiding us to success in the ever-exciting world of clinical trials. Don't miss this opportunity to lead and innovate in a dynamic environment where excellence is the ultimate destination

If you are interested in hearing more, please share your CV and a good time for us to talk.

If not… who could you recommend for any of these positions?

Please reach out for further details

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