Allucent

Global drug development services for biotech

Senior Clinical Data Manager

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeAmsterdam, Netherlands

About the Job

Requirements

A life science or healthcare degree, or a combination of education and experience.
At least 5 years of relevant work experience as a Clinical Data Manager in a contract research organization environment.
At least 5 years of experience in drug development and/or clinical research.
Thorough knowledge and understanding of ICH-GCP, 21 CFR Part 11, data privacy guidelines including GDPR and HIPAA, and awareness of local and regional requirements.
Good understanding of medical terminology.
Experience with electronic data capture software systems and other clinical study management tools, including IRT and eCOA.
Experience serving as the data management lead on several studies, preferably across different therapeutic areas and clinical development phases, and experience covering study start-up, conduct, and database lock.
Thorough understanding of relational database components and experience in technical data management practices, including validation plans, testing, and documentation.
Experience with CDISC conventions, including CDASH and TAUG models, and hands-on experience implementing these models.
Experience developing data management standards.
Strong written and verbal communication skills, including good command of English.
Ability to work in a fast-paced, challenging environment at a growing company.
Proficiency with Word, Excel, PowerPoint, and other computer applications.
Administrative excellence and attention to detail.
Strong technical, analytical, and problem-solving skills.
Strong project management skills.
Ability to translate guidelines, rules, and regulations into clear, usable recommendations and simplify complex issues into understandable concepts.
Organizational, negotiating, and motivational skills.

Responsibilities

Lead data management activities and serve as the primary data management contact for relevant internal groups, sponsors, vendors, and investigational sites.
Plan and project required resources, and manage tasks, timelines, risks, and quality.
Monitor tasks and track budgets and forecasts; manage changes in scope, budget, and revenue recognition.
Develop, review, and maintain project-specific data management documents, including data management plans, eCRF specifications, data validation plans, and external data transfer agreements, and ensure adherence to project requirements.
Lead and coordinate clinical study database setup, including eCRF design and database validation requirements.
Participate in reviewing study documents, including protocols, project plans, safety plans or manuals, and statistical analysis plans; lead and coordinate review of electronic case report forms.
Coordinate, oversee, and ensure completion of database user acceptance testing tasks.
Create training materials for electronic data capture users and provide project-specific training as required.
Lead and oversee clinical data review and validation to ensure consistency, accuracy, integrity, and completeness.
Create data-cleaning strategies with relevant functional groups and oversee data releases, including those for DETC, DSMB, and IDMC, interim and final locks, and updates after lock.
Perform or coordinate data transfers and reconciliation activities, including safety event, pharmacokinetic, and other external laboratory data.
Provide project metric reports and status updates, and advise project teams on site performance issues, data trends, protocol non-compliance, and study progress.
Organize and lead study quality review activities.
Assist with project-related contract negotiation and contracting with vendors, including EDC, IRT, and eCOA vendors.
Manage database maintenance, lock, close-out processes, and procedures.
Participate in conference calls and meetings with vendors and sponsors.
Recognize and solve potential problems and evaluate effectiveness.
Maintain study documentation on an ongoing basis and ensure filing is up to date.
Plan documentation supporting internal and external audits and participate in assigned audits.
Align data management and clinical programming best practices, standards, and conventions within the company.
Provide leadership, expertise, and support to department members.
Propose and support efficiency-improvement initiatives.
Support staff learning and development.
Share relevant information at department meetings and organize and lead data management meetings and discussions.
Represent the company at professional meetings, webinars, and seminars.
Train and mentor data management staff, support development of training materials, and train relevant staff.
Participate in interviewing new recruits.
Track data management regulatory developments and updates in consultation with the department Global Head and/or Director, and support process alignment and improvement.
Contribute as a Clinical Data Management subject matter expert to evaluating, improving, and drafting Quality Management System processes and procedures.
Maintain good communication and relationships with current and prospective clients.
Contribute to client evaluations and visits.
Support preparation of proposals and budgets for data management services.
Contribute to other business areas as required.

Desired Qualifications

Experience as the data management lead on studies across different therapeutic areas and clinical development phases is preferred.

Sr. Clinical Data Manager (Europe)

Allucent · Amsterdam, Netherlands (Hybrid) · Full-time · Posted 2026-10-12

Workplace: hybrid

Department: Data Management

Description

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.

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 in CRO environment
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

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)
Participation in our enriching Buddy Program as a new or existing employee
Internal growth opportunities and career progression
Financially rewarding internal employee referral program
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 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.

“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.”

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About the Company

Allucent

Global drug development services for biotech

Allucent provides global drug development services aimed at small and mid-sized biotech firms. Its offerings include therapeutic strategies, clinical trial operations, biometrics, and clinical pharmacology to support regulatory planning and execution. The company works by partnering with biotech teams to design and run clinical studies, extend in-house capabilities, and ensure accurate data collection and analysis across more than 60 countries. It differentiates itself by focusing on smaller biotech clients with end-to-end, globally coordinated development programs, backed by deep regulatory and scientific expertise and long-term collaborations. The goal is to help clients bring new therapies to market safely and efficiently through practical, hands-on development support.

Company size: 1,001-5,000
Company stage: Not listed
Total funding: Not listed
Headquarters: Cary, NC
Founded: 2022

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