Clinical Data Manager
il y a 2 semaines
For the expansion of our Clinical Data Management team, argenx is looking for a Clinical Data Manager (CDM).
Key Accountabilities/Responsibilities:
The CDM is responsible for all data management aspects of the assigned clinical studies from initiation till closure ensuring that clinical data completeness, accuracy and consistency meet the standards of quality for analysis and reporting to regulatory bodies, compliant with the local and global regulations.
The CDM will:
- Take a leadership role with the CRO, clinical study team and other internal and external partners to establish, align and conform data management expectations for the assigned trials.
- Set quality expectations and timelines for data management deliverables and will regularly follow up on data management milestones
- Ensure compliance with SOPs, company policies and regulatory requirements from trial start-up to trial close-out.
For the assigned trial(s) the CDM may be asked to:
- Participate in CRO selection and contract negotiations together with the argenx clinical study team and the Vendor Management representative
- Contribute to development of the protocol for the sections relevant for DM (feasibility of data collection, adherence to industry and argenx standards, (interim) locks) and/or review of protocol versions.
For the assigned trial(s), the CDM will:
- Oversee all deliverables of activities outsourced to CROs as outlined in the SOW and described in the Data Management Trial Oversight plan, including, but not limited to:
- Creation of data collection tools (EDC, DTAs for 3rd party vendors, EDC integrations)
- Creation of essential documents (DMP, UAT documents)
- Creation of submission ready clinical data package per regulatory agencies requirements.
- Creation of archival package of clinical data per argenx requirements
- Oversee all activities related to Data Management:
- Ensure that Data Management essential documents are written in a timely manner and of such quality to allow the evaluation of the conduct of a trial and the quality of the data produced
- Facilitate cross-functional review by applicable stakeholders of essential documents and data management deliverables
- Keep track of project plan, budget, metrics and KPIs. Adjust project plan as needed in consultation with Data Management CRO and Clinical Team.
- Create Data Release Plan in consultation with applicable stakeholders and oversee Data Releases (such as for DSMB/IDMC, interim and final locks, updates after lock) as per plan and blinding rules.
- Participate in User Acceptance Testing Activities for the applicable Data Collection Tools
- Perform adequate Quality Control for data completeness and accuracy
- Contribute to the development in lessons learned and shares best practices within the trial and department.
The CDM will also participate in activities other than study-related:
- Lead/participate in initiatives on process improvements
- Participate in regulatory inspections and company audits
Desired Skills and Experience:
- Knowledgeable in GCP standards, CDISC standards (CDASH, SDTM, ADaM), FDA and ICH guidelines, and recommended CDM best practices
- Experience with tools and systems for managing clinical studies (study progress and metric systems, eCRF systems, metadata repositories)
- Eye for detail, analytical skills
- Able to work effectively within a team matrix as well as independently
- Strong communication and interpersonal skills
- Fluent in English (written and spoken)
- Bachelor’s degree or Master’s degree - medical, para-medical (Biology, Biomedical Sciences, Pharmacy, Veterinary etc.), mathematics or equivalent by experience
- Demonstrated experience in Clinical Data Management
- Experience in managing CROs and vendors is a plus
- Biotech experience is a plus
- Auto-immune and/or orphan disease clinical study background is a plus
-
Clinical Applications Manager
il y a 2 semaines
Gent, Belgique Collins McNicholas Temps pleinExcellent opportunity for a **Clinical Application Manager **to join an innovative start up **Medical Devices company** based in **Belgium**. The **Clinical Application Manager** will lead the team responsible for developing the **advanced mathematical models** of human physiology/anatomy and their interaction with the company's **implantable...
-
Clinical Scientist
Il y a 2 mois
Gent, Belgique Argenx Temps pleinFor the expansion of our Clinical team, argenx is looking for a Clinical Scientist who directs the planning and implementation of clinical programs to meet corporate and clinical research goals. He/she will be the primary clinical/scientific contact for one or multiple clinical studies and provides clinical research expertise within the cross-functional...
-
Clinical Trial Manager
il y a 6 jours
Gent, Flandre, Belgique Argenx Temps pleinAs we are growing, we are currently looking for a Clinical Trial Manager (CTM).The CTM is responsible for all operational aspects of the assigned clinical studies from monitoring initiation till closure of the studies. The successful candidate will have clinical trial operational experience in phase I, II and III drug development phases and is an operational...
-
Clinical Scientist
Il y a 2 mois
Gent, Belgique Argenx Temps pleinFor the expansion of our Clinical team, argenx is looking for a Clinical Scientist who directs the planning and implementation of clinical programs to meet corporate and clinical research goals. He/she will be the primary clinical/scientific contact for one or multiple clinical studies and provides clinical research expertise within the cross-functional...
-
Clinical Trial Manager
il y a 2 semaines
Gent, Belgique Proclinical Temps pleinProclinical is recruiting a Clinical Project Manager/Clinical Trial Manager for a Mid-size CRO. This role is on a permanent basis and is located in Belgium. **Responsibilities**: - Contribute to the strategy or plan for clinical development. - In the allocated clinical study, proactively identify and address problems to the head of trial operations, and/or...
-
Clinical Analyst
il y a 1 semaine
Gent, Belgique Agfa Temps pleinAgfa HealthCare, is a division of the Agfa-Gevaert Group which is headquartered in Mortsel, Belgium and traded on Euronext Brussels (AGFB). At Agfa HealthCare, we support healthcare professionals across the globe to transform the delivery of care. Our focus is 100% on providing best-of-suite Imaging IT software solutions that enable secure, effective and...
-
Clinical Analyst
il y a 4 semaines
Gent, Flandre, Belgique AGFA Temps pleinAgfa HealthCare, is a division of the Agfa-Gevaert Group which is headquartered in Mortsel, Belgium and traded on Euronext Brussels (AGFB). At Agfa HealthCare, we support healthcare professionals across the globe to transform the delivery of care. Our focus is 100% on providing best-of-suite Imaging IT software solutions that enable secure, effective and...
-
Clinical Analyst
il y a 6 jours
Gent, Flandre, Belgique AGFA Temps pleinAgfa HealthCare, is a division of the Agfa-Gevaert Group which is headquartered in Mortsel, Belgium and traded on Euronext Brussels (AGFB). At Agfa HealthCare, we support healthcare professionals across the globe to transform the delivery of care. Our focus is 100% on providing best-of-suite Imaging IT software solutions that enable secure, effective and...
-
Clinical Analyst
il y a 3 semaines
Gent, Flandre, Belgique AGFA Temps pleinAgfa HealthCare, is a division of the Agfa-Gevaert Group which is headquartered in Mortsel, Belgium and traded on Euronext Brussels (AGFB). At Agfa HealthCare, we support healthcare professionals across the globe to transform the delivery of care. Our focus is 100% on providing best-of-suite Imaging IT software solutions that enable secure, effective and...
-
Clinical Analyst
il y a 4 semaines
Gent, Belgique AGFA Temps pleinAgfa HealthCare, is a division of the Agfa-Gevaert Group which is headquartered in Mortsel, Belgium and traded on Euronext Brussels (AGFB). At Agfa HealthCare, we support healthcare professionals across the globe to transform the delivery of care. Our focus is 100% on providing best-of-suite Imaging IT software solutions that enable secure, effective and...
-
Clinical Analyst
il y a 3 semaines
Gent, Belgique AGFA Temps pleinAgfa HealthCare, is a division of the Agfa-Gevaert Group which is headquartered in Mortsel, Belgium and traded on Euronext Brussels (AGFB). At Agfa HealthCare, we support healthcare professionals across the globe to transform the delivery of care. Our focus is 100% on providing best-of-suite Imaging IT software solutions that enable secure, effective and...
-
Clinical Trial Assistant
Il y a 2 mois
Gent, Belgique Proclinical Temps pleinProclinical are partnering with a small Contract Research Organisation (CRO) that provides high-quality clinical research services to the pharmaceutical, biotech, and medical device industries. They are an exciting CRO who are developing in size and are working with exciting companies.They are currently seeking a highly motivated Clinical Trial Assistant to...
-
Clinical Pharmacologist/pharmacometrician
il y a 2 semaines
Gent, Belgique Argenx Temps pleinAs member of Quantitative Clinical Pharmacology and Pharmacometrics (QCP²), the Clinical Pharmacologist/Pharmacometrician will support aspects of clinical pharmacology and responsible for supervising and conducting population PK/PD modeling and simulation activities with emphasis on both early and late-phase drug development. Principal Responsibilities: -...
-
Clinical Trial Supply Manager
il y a 3 semaines
Gent, Belgique MindCapture Temps pleinCLINICAL TRIAL SUPPLY MANAGER - Biopharma- Ghent & remoteWHAT IS OFFERED We offer strong compensation packages that reward your abilities, hard work and ingenuity in achieving success. We reward you with competitive wages and offer a strong package with additional legal benefits such as meal vouchers, eco vouchers, high health insurance (DKV) and group...
-
Team Lead Data Management
Il y a 2 mois
Gent, Belgique VIB Data Core Temps plein**Context**: VIB (Vlaams Instituut voor Biotechnologie) is an entrepreneurial non-profit research institute, with a clear focus on ground-breaking strategic basic research in life sciences and operates in close partnership with the five universities in Flanders. The VIB Data Core is a new initiative that will offer hardware, software, and data-related...
-
Clinical Operations Manager
il y a 6 jours
Gent, Flandre, Belgique Workplace Options Temps pleinFounded in 1982, WPO is the largest independent provider of holistic wellbeing solutions. Through our customized programs, and comprehensive global network of credentialed providers and professionals, we support individuals to become healthier, happier and more productive both personally and professionally. Trusted by 51% of Fortune 500 companies, we deliver...
-
Clinical Trial Assistant
il y a 6 jours
Gent, Flandre, Belgique Proclinical Temps pleinProclinical are partnering with a small Contract Research Organisation (CRO) that provides high-quality clinical research services to the pharmaceutical, biotech, and medical device industries. They are an exciting CRO who are developing in size and are working with exciting companies.They are currently seeking a highly motivated Clinical Trial Assistant to...
-
Clinical Trial Supply Manager
il y a 6 jours
Gent, Flandre, Belgique MindCapture Temps pleinCLINICAL TRIAL SUPPLY MANAGER Biopharma Ghent & remoteWHAT IS OFFEREDWe offer strong compensation packages that reward your abilities, hard work and ingenuity in achieving success.We reward you with competitive wages and offer a strong package with additional legal benefits such as meal vouchers, eco vouchers, high health insurance (DKV) and group insurance....
-
Project Manager Data Analysis
Il y a 2 mois
Gent, Belgique VIB Data Core Temps plein**Context**: VIB (Vlaams Instituut voor Biotechnologie) is an entrepreneurial non-profit research institute, with a clear focus on ground-breaking strategic basic research in life sciences and operates in close partnership with the five universities in Flanders. The VIB Data Core is a new initiative that will offer hardware, software, and data-related...
-
Data Steward
Il y a 2 mois
Gent, Belgique VIB Data Core Temps plein**Context**: VIB (Vlaams Instituut voor Biotechnologie) is an entrepreneurial non-profit research institute, with a clear focus on ground-breaking strategic basic research in life sciences and operates in close partnership with the five universities in Flanders. The VIB Data Core is a new initiative that will offer hardware, software, and data-related...
