Clinical Operations Manager
il y a 2 semaines
**Responsibilities**:
- Organization and management of clinical operations activities, adhering to standards and regulations required within the field: notably ICH guidelines (including GCP) and all other EU/US legislation and directives relating to clinical research activities.
- Development, management and evaluation of all aspects about “Clinical Compliance” in partnership with the Clinical Quality representative
- In partnership with the Clinical Director and Clinical Science Manager:
- Review and provide expert clinical operations input into clinical documents related to the drug development process including Investigator Brochures, INDs, IMPDs, study synopses and protocols, clinical study reports, DSURS and other safety reports.
- Provide input into clinical trial timeless of the clinical development plan.
- Execute clinical trials from protocol design to the final clinical study report.
- Streamline financial management to ensure proper forecasting, budgeting and oversight for the implementation of the clinical development plan.
- Provide expert clinical operations input into preparation for essential regulatory meetings (e.g., Pre-IND, End-of-Phase 2, Scientific Advice Meetings)
- Line management of the clinical operations team
- Provide as needed hands-on support to the clinical operations team in the:
- Preparation and/or management of all documentation relating to a clinical trial (e.g., study protocol, patient informed consent, CRF, trial management plan, risk management plan, safety plan)
- Selection and management of CRO and other sub-contractors involved in the clinical trials.
- Management of interactions with ethics committees and competent authorities
- Monitoring and coordination of patient recruitment plans
- Coordination of exchanges with investigators and management of site visits
- Training/ coaching operational teams involved in clinical trials (interna and external)
- Conduct of on-site monitoring, trial logistics, and establishing permanent contact with named investigators.
**Profile**:
- Scientific educational background: Master or PhD.
- Minimum 10 years of experience in clinical research experience with a pharmaceutical company or CRO (preferably including people management) with a hands-on-mentality.
- Management experience with multi-center studies including global clinical trials (US study conduct is an asset).
- Strong understanding of the principles of clinical trial conduct and project management.
- Solid experience in CRO management.
- Strong regulatory knowledge, including Good Clinical Practices (GCPs).
- Experience with protocol, ICF, CRF and CSR development and review.
- Strong organizational skills and ability to deal with competing priorities.
- Excellent leadership skills.
- Solid computer skills with a working knowledge of Windows and Microsoft Office.
- Good oral and written communication skills, be able to communicate effectively in English.
**Offer**:
- A full-time permanent position (40h/week) within a high-potential innovative biotech company.
- To work in a human-sized, dynamic, respectful, and professional environment.
- The opportunity to take part in a challenging scientific and business growth.
- An attractive salary package in line with the position responsibilities and your experience.
-
Clinical Operations Manager
il y a 6 jours
Mont-Saint-Guibert, Wallonie, Belgique Novadip Biosciences Temps pleinResponsibilities: Organization and management of clinical operations activities, adhering to standards and regulations required within the field: notably ICH guidelines (including GCP) and all other EU/US legislation and directives relating to clinical research activities. Development, management and evaluation of all aspects about "Clinical Compliance" in...
-
Clinical Trial Assistant
il y a 5 jours
Mont-Saint-Guibert, Wallonie, Belgique Novadip Biosciences Temps pleinYour responsibilities: Primary Role_Trial Master File management and administrative support, in compliance with SOPs, ICH guidelines (including GCP) and all other EU/US legislations and directives relating to clinical research activities. Nature and scope of responsibilities_Trial Master File (TMF) management from study start-up to close-out, ensuring all...
-
Clinical Trial Assistant
il y a 4 jours
Mont-Saint-Guibert, Belgique Novadip Biosciences Temps plein**Your responsibilities**: - Primary Role_ Trial Master File management and administrative support, in compliance with SOPs, ICH guidelines (including GCP) and all other EU/US legislations and directives relating to clinical research activities. - Nature and scope of responsibilities_ 1.Trial Master File (TMF) management from study start-up to close-out,...
-
Manager-clinical Trial Distribution Material
il y a 2 semaines
Mont-Saint-Guibert, Belgique Lilly Temps pleinAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Manager-clinical Trial Distribution Material
il y a 1 semaine
Mont-Saint-Guibert, Belgique Lilly Temps pleinAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...
-
Manager-clinical Trial Distribution Material
il y a 5 jours
Mont-Saint-Guibert, Wallonie, Belgique Lilly Temps pleinAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
Vp of Operations
il y a 4 semaines
Mont-Saint-Guibert, Belgique Cellistic Temps pleinThe mission of Cellistic/ Ncardia Belgium is to understand human iPSC and developmental biology and harness this knowledge to develop and manufacture iPSC therapeutics that significantly improve patient outcomes. We are convinced that pluripotent stem cell technology is the key to getting better, more efficient treatments to patients faster. To achieve this...
-
Project Manager
il y a 2 semaines
Mont-Saint-Guibert, Belgique Panda International Temps plein**Project manager**: **Location** - mont saint guibert, Belgium **Business Sector** - Biotechnology **Job ref** - 22774 **Published** - 2 minutes ago **Title: Project Manager**: **Location**: Wallonia, Belgium We are looking for a seasoned Project Manager (5-6 years of experience) with a proven track record in managing complex projects. You are...
-
Scientific Writer
il y a 7 jours
Mont-Saint-Guibert, Belgique Novadip Biosciences Temps plein**Organization**: As Scientific Writer, you will report to the Chief Operating Officer and will be part of an international cross-functional team full of passion! **Description**: As a Scientific Writer, you drive and are accountable for high quality and timely end-to-end document development. You manage all content-related matters and lead consolidation...
-
Qualifed Person Verification Support
il y a 3 semaines
Mont-Saint-Guibert, Belgique Unique Temps plein**Description**: **ROLE** - Support the compilation and verification of documentation provided relating to the requirements of MHRA guidance for the importing of IMPs into Great Britain from approved countries. Verification will involve the review of documentation provided by the clinical trial study sponsor and /or external contract giver, as applicable, to...
-
QA Operations and Validation Manager
il y a 2 semaines
Mont-Saint-Guibert, Belgique Cellistic Temps pleinThe mission of Cellistic/ Ncardia Belgium is to understand human iPSC and developmental biology and harness this knowledge to develop and manufacture iPSC therapeutics that significantly improve patient outcomes. We are convinced that pluripotent stem cell technology is the key to getting better, more efficient treatments to patients faster. To achieve this...
-
Metrology Manager
il y a 2 semaines
Mont-Saint-Guibert, Belgique CLINIGEN CLINICAL SUPPLIES MANAGEMENT BELGIUM Temps pleinDefine a planning for the maintenance of all equipment, infrastructure Be responsible for all aspects of Metrology & EMS within the Facilities department Be responsible for the organization, prioritization and distribution of tasks of the Metrology and EMS department Maintain and oversee training of the Metrology & EMS team members Define the key...
-
Qualifed Person Verification Support
il y a 5 jours
Mont-Saint-Guibert, Wallonie, Belgique Unique Temps pleinDescription:ROLE Support the compilation and verification of documentation provided relating to the requirements of MHRA guidance for the importing of IMPs into Great Britain from approved countries. Verification will involve the review of documentation provided by the clinical trial study sponsor and /or external contract giver, as applicable, to verify a...
-
Marketing Manager
Il y a 2 mois
Mont-Saint-Guibert, Belgique Clinigen Temps pleinWe’re looking for a Marketing Manager based in Belgium to work on a remote hybrid basis. This position is responsible for designing and implementing marketing and communication initiatives to support the Clinical Services business, as well as other business units and Group-wide projects, as needed. Acting as a Marketing Business Partner, the role aims to...
-
Marketing Manager
il y a 6 jours
Mont-Saint-Guibert, Wallonie, Belgique Clinigen Temps pleinWe're looking for a Marketing Manager based in Belgium to work on a remote hybrid basis. This position is responsible for designing and implementing marketing and communication initiatives to support the Clinical Services business, as well as other business units and Group-wide projects, as needed. Acting as a Marketing Business Partner, the role aims to...
-
Production Manager
Il y a 2 mois
Mont-Saint-Guibert, Belgique Cellistic Temps pleinThe mission of Cellistic/ Ncardia Belgium is to understand human iPSC and developmental biology and harness this knowledge to develop and manufacture iPSC therapeutics that significantly improve patient outcomes. We are convinced that pluripotent stem cell technology is the key to getting better, more efficient treatments to patients faster. To achieve this...
-
Clinical Trials Budget Manager
il y a 6 jours
Woluwe-Saint-Lambert, Région de Bruxelles, Belgique Breast International Group (BIG) Temps pleinFunction: Manage the budget activities of BIG HQ related to its various clinical trials, research program and grants, including related reports.Primary Responsibilities: Prepares and participates in negotiating and followingup of BIG clinical research budgets, together with project teams. Responsible for the grants' budget preparation and financial reporting...
-
Project Manager Start-up
il y a 6 jours
Woluwe-Saint-Lambert, Région de Bruxelles, Belgique Labcorp Temps pleinThis role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Labcorp Drug Development client's policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the SCOM or CRD, the person is responsible for...
-
Training and Education Manager
il y a 2 semaines
Mont-Saint-Guibert, Belgique Guided Solutions Temps pleinOur client is a fast-growing medical technology company focused on the development and commercialization of innovative solutions and services for the treatment of Obstructive Sleep Apnea (OSA). With this method, patients who are not allowed to undergo conventional treatment receive a significant reduction in apnea and hypopnea events. As part of their...
-
Training and Education Manager
il y a 6 jours
Mont-Saint-Guibert, Wallonie, Belgique Guided Solutions Temps pleinOur client is a fast-growing medical technology company focused on the development and commercialization of innovative solutions and services for the treatment of Obstructive Sleep Apnea (OSA). With this method, patients who are not allowed to undergo conventional treatment receive a significant reduction in apnea and hypopnea events.As part of their...