Clinical Affairs Program Manager Belgium
il y a 3 semaines
Social network you want to login/join with:
Clinical Affairs Program Manager BelgiumClient:Not specified
Location:Not specified
Job Category:Other
EU work permit required:Yes
Job Reference:d74dee0b5e2c
Job Views:71
Posted:23.01.2025
Expiry Date:09.03.2025
Job Description:Job Description
Our client is a global medical device company, a pioneer of the MR-guided focused ultrasound technology which is a game-changing innovation. They are looking for a Clinical Affairs Program Manager Europe. The role is % remote with up to 40% travel and based in Europe.
As part of the global clinical affairs team, you will be responsible for developing strategies for a successful execution of roadmap clinical trials that demonstrate medical product safety and efficacy. Additional responsibilities include management of clinical trials approvals with local IRBs and/or Competent Authorities.
Required Skills and Experience:- BS, BA, BSN or RN or higher degree in the Life Sciences or related disciplines
- Minimum 3+ years in clinical management position in biopharmaceutical or device industry, Clinical Research Organization. Biopharmaceutical experience would provide a strong advantage
- Additional 4+ years direct experience in clinical trial management
- Solid track record in successfully executing Phase I – III clinical trials
- Demonstrated expert knowledge and comprehensive understanding of applicable GCP, ICH, ISO guidelines. Additional FDA and or Health Canada experience would provide a strong advantage but will not be required.
- Strong, hands-on manager with experience in managing Core Labs, data management, biostatistics, and medical safety reporting
- Knowledge of electronic data capture systems and web-based clinical trial management tools
- Excellent interpersonal, written / verbal communication, computer & organizational skills, strong program management and financial skills
- Excellent command of the English language; both written and verbal. Additional language beside native language is a significant advantage
- Collaborative team player with strong abilities to operate independently
- Willing & able to travel domestically and internationally, as required (up to 40%)
- Collaborate with Company Stakeholders to execute company objectives into successful clinical trials, investigator-sponsored studies, etc.
- Overall responsibility for design of clinical trials including protocol development, clinical trial discussions with EU Competent Authorities, and development of timeline and budget
- Manage the process of screening/qualifying, selecting, and contracting with investigators, sites and vendors required for conduct of clinical trials
- Direct/Manage necessary clinical trial approvals from IRBs/ECs, and ensure studies are on track for site initiation, patient recruitment and enrollment; take corrective actions where necessary to address issues
- Develops budget for all clinical projects and adhere to company financial goals
- Ensure clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications
- Develop, maintain and expand collaborations with Company Stakeholders, clinical investigators and researchers, and key opinion leaders to optimize the clinical development programs
- Participate in the development of SOPs and work instructions to assure internal files and clinical study files (patient; site; country) conform to Good Clinical Practice regulations and standards
- Ensure adherence to protocols and compliance with regulatory (FDA/ICH/ISO/GCP) guidelines as well as SOP procedures
- Identify clinical training needs and develop training materials for in-house and clinical site use
-
Medical Affairs Manager
il y a 3 semaines
belgium MAP Patient Access Limited Temps pleinWHO WE AREWe are Kintiga, a pan-European specialist that partners with ambitious health technology developers through the complex journey to achieve successful patient access across Europe, with our tailored approach, global perspective and local expertise. Kintiga unites three companies: MAP Patient Access (UK), AxTalis (Benelux), and SKC Consulting...
-
Medical Affairs Manager
il y a 3 semaines
belgium, belgique WhatJobs Temps pleinWHO WE ARE We are Kintiga, a pan-European specialist that partners with ambitious health technology developers through the complex journey to achieve successful patient access across Europe, with our tailored approach, global perspective and local expertise. Kintiga unites three companies: MAP Patient Access (UK), AxTalis (Benelux), and SKC Consulting...
-
Regulatory Affairs Manager M/F
il y a 3 semaines
belgium TN Belgium Temps pleinSocial network you want to login/join with:You are a highly skilled professional with a passion for the world of Life Sciences and Clinical Research? You want to thrive in a dynamic and collaborative international environment where your expertise directly impacts people's lives?Come and join Aixial Group to contribute to shaping the future of clinical...
-
Sr. Medical Affairs Manager, Benelux
il y a 3 semaines
belgium Insulet Corporation Temps pleinSr. Medical Affairs Manager, Benelux (Remote/Flexible)Apply locations Netherlands, Belgium, United Kingdomtime type Full timeposted on Posted 6 Days Agojob requisition id REQ-2024-8532Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom, and healthier lives through the use of our Omnipod product platform. In...
-
Sr Manager Medical Affairs
il y a 3 semaines
belgium Insulet Corporation Temps pleinSr Manager Medical Affairs - Distributor Markets (Remote/Flexible) (w/m/d) page is loadedSr Manager Medical Affairs - Distributor Markets (Remote/Flexible) (w/m/d)Apply locations Germany Switzerland Netherlands France United Kingdom time type Full time posted on Posted 30+ Days Ago job requisition id REQ-2024-7077Insulet started in 2000 with an idea and a...
-
Sr. Medical Affairs Manager, Benelux
il y a 3 semaines
belgium, belgique WhatJobs Temps pleinSr. Medical Affairs Manager, Benelux (Remote/Flexible) Apply locations Netherlands, Belgium, United Kingdom time type Full time posted on Posted 6 Days Ago job requisition id REQ-2024-8532 Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom, and healthier lives through the use of our Omnipod product...
-
Manager/Sr Manager Clinical Operations
il y a 3 semaines
belgium Thermo Fisher Scientific Temps pleinWork ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed...
-
Clinical Science Liaison Specialist
il y a 3 semaines
belgium Flen Health Group Temps pleinFlen Health is an international family-owned company with ambitious growth plans in the pharmaceutical and medical device technological domain. Flen Health has a range of products for wound and skin care, several new products in the pipeline and research cooperation agreements in Europe and the USA.At Flen Health, we focus on people with topical inflammatory...
-
Sr Manager Medical Affairs
il y a 3 semaines
belgium, belgique WhatJobs Temps pleinSr Manager Medical Affairs - Distributor Markets (Remote/Flexible) (w/m/d) page is loadedSr Manager Medical Affairs - Distributor Markets (Remote/Flexible) (w/m/d) Apply locations Germany Switzerland Netherlands France United Kingdom time type Full time posted on Posted 30+ Days Ago job requisition id REQ-2024-7077Insulet started in 2000 with an idea and a...
-
Regulatory Affairs Consultant
il y a 3 semaines
belgium TN Belgium Temps pleinSocial network you want to login/join with:Regulatory Affairs Consultant (candidate pool)Client: Keyrus Life ScienceLocation: BelgiumJob Category: OtherEU work permit required: YesJob Reference: 2d6099885896Job Views: 23Posted: 23.01.2025Expiry Date: 09.03.2025Job Description:Keyrus Life Science is looking on a regular basis for Regulatory Affairs...
-
Senior Clinical Research Associate
il y a 2 semaines
Belgium Planet Pharma Temps pleinPlanet Pharma are partnered with a leading clinical research organization who are growing rapidly and have revolutionized in particular therapeutic areas such as oncology and rare disease. Our client are seeking a Senior CRA with an eagerness to develop and a passion for clinical trials. in this role you'll be on dedicated studies and not taking on 2 studies...
-
Clinical Application Specialist
il y a 3 semaines
belgium TN Belgium Temps pleinTitle: Exciting Opportunity for Clinical Application Specialist in Belgium!Introduction:We are thrilled to offer an outstanding opportunity for an ambitious and skilled Clinical Application Specialist to join our team. Our client is searching for a candidate who possesses at least 2 years experience in technical medical devices, excellent communication...
-
Research Nurse- Leuven, Belgium
il y a 3 semaines
belgium Syneos Health, Inc. Temps pleinUpdated: January 8, 2025Location: Belgium-Europe - BEL-Home-BasedJob ID: 25001055Illingworth Research Group provides a range of patient-focused clinical services to the pharmaceutical, healthcare, biotechnology, and medical device industries. These include mobile research nursing, patient concierge, medical photography, and clinical research services....
-
Public Affairs Officer
il y a 3 semaines
belgium MAVENCE Temps pleinThe company is hiring a Public Affairs Officer to support the development of renewable energy production in Belgium, with a focus on onshore wind and solar energy.The Public Affairs Officer will work in Flanders, Wallonia, Brussels and at federal level, with contacts with both political and local stakeholders throughout the country.Your activities will...
-
Program Manager, null
il y a 3 semaines
belgium TN Belgium Temps pleinDescription du role d'un Program ManagerPour un de nos clients, actif dans le secteur pharmaceutique, nous recherchons activement un Construction Manager Senior.Le Program Manager applique les connaissances, les compétences, les outils et les techniques à un programme afin d'en satisfaire les exigences et d'obtenir des avantages et des contrôles que la...
-
Program Manager
il y a 3 semaines
belgium TN Belgium Temps pleinSocial network you want to login/join with:Location: Glasgow Scotland Hybrid WFH and onsite. Will also consider fully remote in UK, Belgium, The Netherlands, Sweden or Poland. If remote, must be willing to travel to Glasgow once per month.Excellent Pay and Benefits!This is an outstanding place to work!It all starts with the people. You will love working with...
-
Regulatory Affairs Manager, Personal Health Care
il y a 3 semaines
belgium Healixia Temps pleinRegulatory Affairs Manager, Personal Health CareNovember 18, 2024Have you ever thought about applying your technical knowledge to contribute to building the Pharmaceutical and Health Care business? Are you a leader who possesses, in addition to technical skills, an entrepreneurial spirit, real passion for winning, and the ability to build reciprocal...
-
Product Manager Entrepreneurship Programmes
il y a 3 semaines
belgium PKF-VMB Belgium Temps pleinGhent, BelgiumEmployeePartial Remote JobDo you have a passion for sales and customer relationship management? Are you result driven & ready to explore the world of our entrepreneurship programmes and the entrepreneurial community we serve? Would you like to join and help build the inspiring Vlerick Entrepreneurship Academy?PRODUCT MANAGER ENTREPRENEURSHIP...
-
Clinical Supply Lead
il y a 3 semaines
belgium Hobson Prior Temps pleinHobson Prior is seeking a Clinical Supply Lead. This role involves managing the supply chain for clinical trials, including packaging, labelling, and distribution of materials. The successful candidate will also be responsible for forecasting supply and demand, problem-solving, and managing budgets.Please note that to be considered for this role you must...
-
Global Regulatory Affairs CMC Lead CAR-T Princeton,US
il y a 3 semaines
belgium Galapagos Temps pleinPleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in US, headquartered in Mechelen, Belgium.We are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class medicines. With...