Clinical Data Manager III

Summary

Join Allucent™ as a Clinical Data Manager III and lead data management activities, ensuring data quality and regulatory compliance. You will manage and coordinate deliverables from database design to reporting, collaborating with internal and external stakeholders. Key responsibilities include planning resources, developing documentation, coordinating database setup and validation, reviewing data, and creating reports. This role requires a life sciences degree, 3+ years of relevant experience, and expertise in ICH-GCP, EDC software, and CDISC conventions. Allucent offers a comprehensive benefits package, flexible working hours, remote work options, professional development opportunities, and a supportive work environment.

Requirements

• Life Sciences, Healthcare degree and/or combination of education and experience
• Minimum 3 years of relevant work experience as Clinical Data Manager
• Minimum 3 years of experience in drug development and/or clinical research
• Good knowledge and understanding of ICH-GCP, 21CFR11 data privacy (GDPR/HIPPA) guidelines and awareness of local/regional requirements
• Good understanding of Medical Terminology
• Experience with electronic data capture (EDC) software systems and other tools for managing clinical studies, including IRT and eCOA
• Active participation, support and leadership in Data Management activities related to database setup, data cleaning and query management, external data reconciliation for several studies
• Thorough understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation
• Experienced in CDISC conventions, i.e., CDASH, TAUG models and hands on experience implementing these models
• Strong written and verbal communication skills including good command of English language
• Representative, outgoing and client focused
• Ability to work in a fast-paced challenging environment of a growing company
• Proficiency with various computer applications such as Word, Excel, and PowerPoint required
• Administrative excellence
• Eye for detail, strong technical, analytical and problem-solving skills
• Good project management skills
• Ability to translate guidelines, rules and regulations in clear and usable recommendations
• Ability to simplify complex issues into understandable concepts

Responsibilities

• Lead and serve as primary contact for DM with all relevant parties, both internally (e.g. Clinical Programmers, Data Scientists, Project Management, Clinical Operations/Monitoring, Biostatistics and externally (e.g. sponsors, vendors (EDC, external data), and investigational sites)
• Plan and project the resources required including management of tasks, timelines, risk and quality
• Monitor tasks against and keep track on budget, forecasts, identify and trigger changes of scope requests
• Develop, review and maintain project-specific DM documents including data management plan (DMP), eCRF specifications, data validation plan (DVP) and external data transfer agreements
• Lead and coordinate the development of clinical study database set-up, including eCRF design and database validation requirements
• Participate in the review of study documents (e.g. protocol, Project Plan, safety plans/manuals and statistical analysis plan), lead and coordinate the review of (electronic) case report forms (eCRFs)
• Coordinate, participate and complete the database User Acceptance Testing (UAT) related tasks
• Create training materials for EDC users and provide project-specific training as required
• Review and validate clinical data to ensure consistency, accuracy, integrity and completeness
• Create data cleaning strategy in consultation with applicable functional groups and assist in data releases (such as for DETC/DSMB/IDMC, interim and final locks, updates after lock)
• Perform and/or coordinate various data transfers and reconciliation activities including (but not limited to) SAE, PK, and (other) external laboratory data
• Create and review project metric reports, status updates, study progress to Lead DM in order to share information on site performance issues, data trends and protocol non-compliance
• Support and conduct Quality Review checks during study & as a Lead DM, may organize and lead Quality Review activities
• Assist in contracts negotiation and contracting process with vendors (EDC, IRT, eCOA)
• Manage the database maintenance, lock and close-out processes and procedure
• Participate in conference calls and/or meetings with vendors and sponsors
• Recognize and solve potential problems and evaluate effectiveness
• Maintain DM study documentation on an ongoing basis and ensure that all filing is up to date
• Plan and create necessary documentation to support internal and external audits; may participate in such audits assigned
• Help to align data management and clinical programming best practices, standards and conventions within the company
• Propose and support initiatives for improving efficiency
• Actively support to staff learning & development within the company
• Share relevant information at applicable DM departmental meetings and chair or lead DM-related meetings and discussions
• Train and mentor data management staff
• Proactively track Data Management related regulatory development trends and updates, in consultation with department Global Head and/or Director, for further alignment and improvement of current processes
• Contribute in the field of Clinical Data Management activities to the evaluation/improvement of processes and procedures within the Quality Management System
• Assure good communication and relationships with (future) clients
• Contribute to other areas of business as required

Benefits

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid* working depending on location
• Leadership and mentoring opportunities
• Participation in our Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms