Senior Clinical Data Management Professional
3 weken geleden
About Allucent
At Allucent, we are dedicated to providing high-quality services to our clients in the biopharmaceutical industry. We strive to deliver innovative solutions that meet the ever-changing needs of our clients.
About the Role
We are seeking a highly skilled Senior Clinical Data Management Professional to join our team. As a key member of our data management department, you will be responsible for leading and coordinating clinical study database set-up, ensuring the completeness, accuracy, and consistency of clinical data meets quality standards and regulatory requirements.
Main Responsibilities
- Lead and serve as primary contact for data management with all relevant parties internally and externally;
- Plan and project resources required, including management of tasks, timelines, risk, and quality;
- Monitor tasks against budget, forecasts, and manage changes of scope, budget, revenue recognition;
- Develop, review, and maintain project-specific data management documents, including data management plan (DMP), eCRF specifications, data validation plan (DVP), and external data transfer agreements;
- 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, 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;
- Perform and/or coordinate various data transfers and reconciliation activities, including SAE, PK, and external laboratory data;
- Provide project metric reports, status updates, study progress, feedback, and advice to the project team on site performance issues, data trends, and protocol non-compliance;
- Organize and lead Quality Review activities during studies;
- Assist in project-related contracts negotiation and contracting process with vendors (EDC, IRT, eCOA);
- Manage database maintenance, lock, and close-out processes and procedures;
- 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 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 staff learning and 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).
Benefits
Allucent offers a comprehensive benefits package, including competitive salaries, flexible working hours, opportunity for remote/hybrid working, leadership and mentoring opportunities, participation in our Buddy Program, internal growth opportunities and career progression, financially rewarding internal employee referral program, access to online soft-skills and technical training, eligibility for Spot Bonus Award Program, and Loyalty Award Program.
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