Senior Clinical Data Manager - I

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

Senior Clinical Data Manager I (Sr CDM1) leads data management activities of the Allucent Data Management (DM) department.

This position manages, coordinates, reviews and approves DM deliverables from database design & set-up, through cleaning and reporting to database locking, ensuring that the completeness, accuracy and consistency of clinical data meet the quality standards and regulatory requirements for analysis and reporting.

This position also provides expertise in relevant data management areas and cross-functional initiatives, including the development of departmental processes, tools, and training of staff.

The Sr CDM1 provides support in Request for Proposals (RFPs) and presents at Business Development (BD) Meetings.

The Sr CDM1 is a member of the Data Management staff.

• 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, Clinical Monitoring, Biostatistics and other functional groups) 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 and manage changes of scope, budget, revenue recognition.
• Develop, review and maintain project-specific DM documents including data management plan (DMP), e CRF specifications, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements
• Lead and coordinate the development of clinical study database set-up, including e CRF 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 (e CRFs)
• Coordinate, oversee and ensure the database User Acceptance Testing (UAT) related tasks are successfully completed
• Create training materials for EDC users and provide project-specific training as required
• Lead and oversee the review and validation of clinical data to ensure consistency, accuracy, integrity and completeness
• Plan and project the resources required including management of tasks, timelines, risk and quality
• Monitor tasks against and keep track on budget, forecasts and manage changes of scope, budget, revenue recognition.
• Develop, review and maintain project-specific DM documents including data management plan (DMP), e CRF specifications, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements
• Lead and coordinate the development of clinical study database set-up, including e CRF 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 (e CRFs)
• Coordinate, oversee and ensure the database User Acceptance Testing (UAT) related tasks are successfully completed
• Create training materials for EDC users and provide project-specific training as required
• Create data cleaning strategy in consultation with applicable functional groups and oversee 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
• Provide project metric reports, status updates, study progress, feedback and advice to project team on site performance issues, data trends and protocol non-compliance
• Organize and lead Quality Review activities during stud
• Assist in project-related contracts negotiation and contracting process with vendors (EDC, IRT, e COA)
• 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
• Provide leadership, expertise and support to other department members.
• 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 organize and lead DM-related meetings and discussions
• Represent the company at professional meetings, webinars or seminars
• Train and mentor data management staff, support in development of new training material and provide training to relevant staff
• Participate in the interview process for new recruits
• 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 as Clinical Data Management Subject Matter Expert (SME) to the evaluation/improvement/drafting of processes and procedures within the Quality Management System
• Assure good communication and relationships with (future) clients
• Contribute to and take part in client evaluations and visits
• Support in preparation of new proposals and budgets for Data Management services
• Life science, healthcare degree and/or combination of education and experience
• Minimum 5 years of relevant work experience as Clinical Data Manager
• Minimum 5 years of experience in drug development and/or clinical research
• Thorough 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 e COA
• Experience as DM lead on several studies, preferably in different Therapeutic Areas and clinical development phases.

Experience in covering all phases of a clinical study (start up, conduct and database lock).

• 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
• Experience in developing data management standards

Benefits of working at Allucent include

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Leadership and mentoring opportunities
• Participation in our enriching 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 Good Habitz and internal platforms
• Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
• Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees.
• About Allucent

Our mission is to help bring new therapies to light.

When you work at Allucent, that means applying your unique skill set, expertise, and knowledge to build partnerships with our clients in their pursuit to develop new, life-improving treatments.

If you’re passionate about helping customers develop new pharmaceuticals and biologics; have an entrepreneurial spirit; and ready to join other science, business, and operations leaders, we would love to get to learn more about how we can help each other grow.

Together we SHINE. find more information about our values.

Disclaimers

*Our in-office 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.

For this role you can be home-based.

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