Support DM-related activities and collaborate with Lead DMs, Clinical Programmers, Data Scientists, Clinical Monitoring teams, and other functions like Project Management, Clinical Operations, and Biostatistics
• Provide regular updates to Lead DM on progress, timelines, risks, and quality; support resource planning when assigned as Lead CDM
• Track tasks against budget and forecasts; identify and initiate scope change requests when required
• Develop, review, and maintain key DM documents such as DMP, eCRF specifications, DVP, and external data transfer agreements
• Support or lead clinical database setup, including eCRF design and validation requirements
• Participate in reviewing study documents like protocols, project plans, safety plans, and statistical analysis plans
• Coordinate and complete User Acceptance Testing (UAT) activities for databases
• Create training materials and provide EDC training for study teams
Requirements
Review and validate clinical data to ensure accuracy, consistency, integrity, and completeness
• Support data cleaning strategies and assist in data releases (interim, final locks, and post-lock updates)
• Perform and coordinate data transfers and reconciliation activities (SAE, PK, lab data, etc.)
• Prepare and review project metrics and status reports, highlighting site performance, data trends, and protocol deviations
• Support and conduct Quality Review activities; may also lead these when required
• Support or manage database maintenance, lock, and close-out activities
• Participate in meetings with vendors and sponsors as needed
• Identify issues, solve problems, and assess effectiveness of solutions
• Maintain up-to-date DM documentation and ensure proper filing throughout the study
• Prepare documentation for audits and participate in internal/external audits when assigned
• Support alignment of data management and clinical programming standards and best practices
• Contribute to process improvement initiatives to enhance efficiency
Benefits
Benefits of working at Allucent include:
Disclaimers:
*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. The company is purpose-built through the convergence of leading providers to address this unmet need. Today, Allucent is a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, Allucent’s individualized partnership approach provides experience-driven insights and expertise to assist its clients in successfully navigating the complexities of delivering novel treatments to patients.
