Sr. Clinical Data Manager I

As a Senior Clinical Data Manager I at Allucent, your role involves leading data management activities in the Allucent Data Management (DM) department. You will be responsible for managing, coordinating, reviewing, and approving DM deliverables from database design & set-up to database locking. It is crucial to ensure the completeness, accuracy, and consistency of clinical data to meet quality standards and regulatory requirements for analysis and reporting. Additionally, you will provide expertise in relevant data management areas, participate in cross-functional initiatives, and contribute to the development of departmental processes, tools, and staff training. Your involvement in Request for Proposals (RFPs) and Business Development (BD) Meetings is also expected. Your key responsibilities will include: - Leading and serving as the primary contact for DM with internal and external parties - Planning and projecting required resources, managing tasks, timelines, risk, and quality - Developing, reviewing, and maintaining project-specific DM documents - Coordinating the development of clinical study database set-up, eCRF design, and database validation requirements - Creating training materials for EDC users and conducting project-specific training - Overseeing data cleaning strategy, data releases, transfers, and reconciliation activities - Providing project metric reports, status updates, study progress, and feedback to the project team - Maintaining DM study documentation, supporting audits, and aligning best practices - Participating in client evaluations, preparing proposals and budgets for Data Management services, and staying updated on regulatory trends Qualifications required for this role: - Life science, healthcare degree and/or combination of education and experience - Minimum 5 years of relevant work experience as a Clinical Data Manager - Thorough knowledge of ICH-GCP, 21CFR11 data privacy guidelines, and awareness of local/regional requirements - Experience with EDC software systems, IRT, eCOA, and CDISC conventions - Strong written and verbal communication skills, organizational, negotiating, and motivational skills - Ability to work in a fast-paced challenging environment and proficiency with computer applications Working at Allucent offers the following benefits: - Comprehensive benefits package - Competitive salaries - Departmental Study/Training Budget for professional development - Flexible working hours and remote/office-based working opportunities - Leadership and mentoring opportunities - Internal growth opportunities, employee referral program, and access to online training platforms Please note that Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any open roles. Candidates should never be submitted directly to hiring managers, employees, or human resources.,