Clinical Program Manager

il y a 11 heures


Brussels, Belgique Inari Medical Temps plein

**Description**
The Clinical Research Program Manager is responsible for leading all aspects of clinical trial management across the study life-cycle from planning to execution to closure. They work with cross functional partners or Contract Research Organizations to collect and deliver high quality evidence, enabling patient access to advanced care of their vascular disease.

**Responsibilities**

*
Designs, plans, and implements the clinical trial to demonstrate safety, efficacy, economic, and quality of life outcomes for the performance of Inari products and solutions potentially at a global scale.
- Determines study objective, strategy, scope and schedule in order to meet business needs.
- Able to effectively influence cross-functional team members and external medical professionals to ensure project deliverables are completed on time/budget.
- Partners and aligns with internal and external stakeholders to support global regulatory approvals, reimbursement coverage, market penetration, and market expansion.
- Able to see multiple viewpoints and build consensus to reach resolutions.
- Help establish the conditions essential for determining the safety, efficacy, medical usefulness, and marketability of medical devices.
- Develops the Clinical Investigational Plan and supporting documents (IB, PIC,Safety Plan, Data Management Plan, etc) in consultation with the cross-functional project teams, investigators and the clinical team
- Provide clinical training of investigators, center staff, CRO partners, and Inari team members.
- Participates with technical and clinical experts in safety review of clinical data.
- Evaluate, analyze and validate all clinical data per data management plan for ongoing analysis and publications throughout study execution.
- Provides robust sponsor oversight to all clinical sites and CRO in compliance with CIP and overall clinical objectives.
- Participate in the selection and management of CRO partners.
- Perform site visits to supervise and coordinate clinical studies and to discuss /coordinate publication initiatives.
- Evaluates clinical data/information, providing interim and final reports, convening and directing investigator conferences to review findings and advise on direction.
- Develops a high level of professional scientific technical and clinical expertise through familiarity with relevant literature, by attending scientific meetings, and by interacting with various inside/outside experts or departments/institutes.
- Develops and manages budgets for assigned clinical studies and / or clinical research projects.
- Engages key physician investigators in the development and/or execution of clinical research.
- Prepares outlines, summaries, status reports, etc. for distribution and communication with other departments and executive leadership.
- Follows and helps iterate Clinical SOPs, systems and processes ensuring quality study management.

**Qualifications**
- Bachelor’s degree in the life sciences.
- Master’s degree with a demonstrated research background is preferred.
- Experience with Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).
- Solid understanding of industry trends for clinical and regulatory pathways.
- Proficient project management skills.
- Minimum of 8-10 years’ relevant clinical research experience with significant project management experience.
- Healthy disdain for the status quo.
- Ability to thrive in a fast-paced and dynamic early stage company work environment.
- Medical device trials experience preferred.
- Detail oriented with ability to deliver high quality output consistently and on time.
- Ability to thrive in times of change while adhering to cultural focus on People and Patients.


  • Clinical Project Manager

    Il y a 7 mois


    Brussels, Belgique Telix Pharmaceuticals (EMEA) Temps plein

    Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. **At our core, we exist to create products that seek to improve the quality of life for people living with...

  • Clinical Project Manager

    il y a 2 semaines


    Brussels, Belgique Amador Bioscience Temps plein

    **Position Summary** The Clinical Project Manager is responsible for providing direct oversight, management, and follow-up on assigned projects. He/she will be responsible for all aspects of clinical trial-related support, including but not limited to, coordination of statement of work (SOW), invoicing, budget tracking, day-to-day operational support,...

  • Clinical Project Manager

    Il y a 6 mois


    Brussels, Belgique Telix Pharmaceuticals (Americas) Temps plein

    Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. **At our core, we exist to create products that seek to improve the quality of life for people living with...

  • Clinical Project Manager

    Il y a 7 mois


    Brussels, Belgique Telix Pharmaceuticals (EMEA) Temps plein

    Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. **At our core, we exist to create products that seek to improve the quality of life for people living with...

  • Clinical Data Manager

    Il y a 7 mois


    Brussels, Belgique EORTC Temps plein

    The Clinical Data Manager works under the hierarchical supervision of the Clinical Data Expert. The Clinical Data Manager reports on study activities and status to the study team. Main responsibilities / Major Activities The Clinical Data Manager is responsible for all the steps required for the setup of the Data Management tools of a clinical trial and...


  • Brussels, Belgique Mithra Pharmaceuticals SA Temps plein

    Overview: This internship is intended to provide you an elementary understanding of all areas of clinical operations, with a focus on study conduct and data collecting in prospective clinical studies. You will also be able to learn the basics of quality assurance and good clinical practice (ICH-GCP). You will be teamed with two clinical study or clinical...

  • Clinical Project Manager

    il y a 6 jours


    Brussels, Belgique Gabi SmartCare Temps plein

    Then you might be the **Clinical Project Manager** we are looking for! You, as the Clinical Project Manager, will complete the team responsible of Gabi SmartCare’s clinical projects, both in the EU and the US. You: - Manage and refine the operational plan of studies (monitoring plan, deadlines, quality), - Coordinate internal and external clinical...

  • Clinical Research Associate

    il y a 1 semaine


    Brussels, Belgique Premier Research Temps plein

    The Clinical Research Associate II (CRA II) is accountable for conducting monitoring activities of assigned clinical trials in compliance with the protocol, ICH-GCP/ISO14155 and all applicable local laws and regulations, company policies and quality standards. He or she performs the management of study site activities to ensure the collection of accurate...

  • Program Manager

    il y a 7 jours


    Brussels, Belgique CordenPharma Brussels Temps plein

    Brussels, BE **Our Company** CordenPharma is a leading Contract Development & Manufacturing (**CDMO**) partner with approximately 2’000 employees across Europe and the United States and annual revenues > 500 M€, enabling pharmaceutical and biotechnology companies to link their requirements for product success with their patients’ healthier...

  • Clinical Project Manager

    il y a 1 semaine


    Brussels, Belgique Gabi SmartCare Temps plein

    You, as the Clinical Project Manager, will complete the team responsible of Gabi SmartCare’s clinical projects, both in the EU and the US. You: - Manage and refine the operational plan of studies (monitoring plan, deadlines, quality), - Coordinate internal and external clinical development activities and participate in the selection of study sites -...


  • Brussels, Belgique Inari Medical Temps plein

    **Description** Supporting role for the Clinical Research team, mainly related to trial conduct and site management activities in the U.S. following good clinical practice and all applicable regulations. This position will work collaboratively with the external Contract Research Organization, external vendors, field Clinical Research Associates, additional...


  • Brussels, Belgique AMA European Consulting Temps plein

    **Context**: We are part of a digital clinical operations team responsible for managing various digital solutions in clinical trials, particularly focusing on MyVeeva, a clinical outcomes assessment solution. This role supports and helps configure MyVeeva based on study team requirements and clinical operations. The role involves understanding clinical...


  • Brussels, Belgique Novasyte Temps plein

    IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to...

  • Clinical Site Manager

    il y a 2 jours


    Brussels, Belgique Hobson Prior Temps plein

    Hobson Prior are currently seeking for a Clinical Site Manager to join a fantastic pharmaceutical establishment on a contract basis located in Brussels. Our client is focused on producing valuable solutions to improve the lives of many. Please note that to be considered for this role you must have the right to work in this location. **Key...


  • Brussels, Belgique EORTC Temps plein

    The Clinical Operations department is looking for two Junior Clinical Operations Managers (Jr COMs) to reinforce its team. The Junior Clinical Operations Manager works under the hierarchical supervision of the Head of the Clinical Operations Department. Main responsibilities / Major Activities Communicates adequately with the various stakeholders and third...


  • Brussels, Belgique Medtronic Temps plein

    **Careers that Change Lives** As Clinical Education Specialist, you will be responsible to develop, directing, and executing the Training and Education programs aligned with corporate strategies in the region. This includes, but is not limited to Clinical Immersion Programs (preceptor and proctorship), peer-to-peer educational programs, fellows and...


  • Brussels, Belgique Thermo Fisher Scientific Temps plein

    At 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 to achieve individual career goals while taking science a step beyond through...

  • Clinical Trial Coordinator

    il y a 2 semaines


    Brussels, Belgique Thermo Fisher Scientific Temps plein

    Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global...


  • Brussels, Belgique Thermo Fisher Scientific Temps plein

    Clinical Trial Coordinator (Client dedicated) - Belgium, Hybrid At 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 to achieve...


  • Brussels, Belgique Masimo Temps plein

    **Duties and Responsibilities**: - You will be seen as an expert in pulse oximetry and pulse CO-Oximetry as well as an authority on the clinical impact of various noninvasive patient monitoring solutions. - The Clinical Specialist (CS) will be responsible for educating Masimo customers on our products and solutions. - The CS will work with the field in...