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.
The Clinical Data Manager I (CDM1) assists in data management related activities of the Allucent Data Management (DM) department.
This position supports other Allucent Clinical Data Managers (CDMs) and Clinical Programmer(s) and performs DM activities 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.
In this role your key tasks will include:
- Assist in DM related tasks and collaborate with Lead DMs and relevant roles within Data Management (e.g. Clinical Programmers, Data Scientist) as well as with Clinical Monitoring staff. May be in contact with other functional groups (e.g Project Management, Clinical Operations/Monitoring, Biostatistics)
- Provide feedback and status updates to Lead DM regarding progress, timelines, risk and quality
- Monitor tasks against budget, forecasts and timely raise/alert changes of scope requests
- Support the development, review and maintenance project-specific DM documents including data management plan (DMP), eCRF, data validation plan (DVP) and external data transfer agreements throughout the lifecycle of the project and ensure adherence to the project requirements
- Provide support during eCRF design and database validation requirements
- Participate in database User Acceptance Testing (UAT) related tasks
- Create training materials for EDC users
- Review and validate clinical data to ensure consistency, accuracy, integrity and completeness
- 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 and document findings
- Support the database maintenance, lock and close-out processes and procedure
- Signal, recognize and solve potential problems and evaluate effectiveness
- Support the maintenance of DM study documentation on an ongoing basis and ensure that all filing is up to date
- Support collection and creation of necessary documentation to support internal and external audits
- 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.
- 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
Requirements
To be successful you will possess:
- Life science, healthcare and/or related field degree
- Minimum 6 months of relevant work experience, e.g. as Data Manager, CRA or Clinical Database Programmer
- Minimum 6 months of experience in drug development and/or clinical research
- Basic knowledge of ICH-GCP, GDPR/HIPPA and applicable (local) regulatory requirements
- Good understanding of Medical Terminology
- Worked with at least one or two electronic data capture (EDC) software systems and other tools for managing clinical studies
- Supported at least one or two studies in data review and query management and participated in User Acceptance testing (UAT) on a couple of studies
- Good understanding of relational database components and experience in technical data management practices (validation plans, testing, and documentation
- Good understanding of CDISC data conventions
- 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
- Good project management skills
- Ability to translate guidelines, rules and regulations in clear and usable recommendations
Benefits
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)
- Opportunity for remote/hybrid* working depending on location
- 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 GoodHabitz 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
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.”
