Sr. Clinical Data Manager

Allucent

Amsterdam or Bristol

We are looking for a Sr. Clinical Data Manager (SrCDM) to join our A-team (hybrid*/remote). As a SrCDM at Allucent you lead 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 meets 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.

In this role your key tasks will include:

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), eCRF 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 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, 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
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 study
Assist in project-related 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
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
Contribute to other areas of business as required

Requirements:

To be successful you will possess:

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 eCOA
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
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
Attention to detail, strong technical, analytical and problem-solving skills
Strong project management skills
Ability to translate guidelines, rules and regulations in clear and usable recommendations
Ability to simplify complex issues into understandable concepts
Excellent organizational, negotiating and motivational skills