Regulatory and Start-up Manager
Il y a 2 mois
Job Overview
Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources.
Essential Functions
- Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines. Develop, implement and maintain the Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues where required. Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan. Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required. Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements. Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team. Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations
- identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan. Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required. Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents. Work with Quality Management to ensure appropriate quality standards for the duration of site activation (or Maintenance, as applicable). Mentor and coach colleagues as required. Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information. May take a lead role in developing long standing relationships with preferred IQVIA customers. Deliver presentations/training to clients, colleagues and professional bodies, as required. May be involved in activities related to monthly study budget planning and reviews.
**Qualifications**:
- Bachelor's Degree Life sciences or related field Req
- 7 years’ relevant experience in a scientific or clinical environment including demonstrable experience in an international role. Equivalent combination of education, training and experience.
- Strong negotiation and communication skills with ability to challenge
- Excellent interpersonal skills and strong team player
- Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects
- Thorough understanding of regulated clinical trial environment and in depth knowledge of drug development process
- Demonstrated proficiency in using systems and technology to achieve work objectives
- Good regulatory and/or technical writing skills
- Good leadership skills, with ability to motivate, coach and mentor
- Good organizational and planning skills
- Ability to exercise independent judgment taking calculated risks when making decisions
- Good presentation skills
- Proven ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
- Excellent understanding of study financial management
- Proven ability to work on multiple projects balancing competing priorities
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at
-
Regulatory and Start Up Specialist
Il y a 2 mois
Paris, France Novasyte Temps pleinJob Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions - Under general supervision, serve...
-
Regulatory & Start Up Specialist, French Speaker
il y a 6 jours
Paris, France Novasyte Temps pleinIQVIA MedTech Clinical Solutions, specializes in clinical research for Medical Devices and In-Vitro Diagnostic (IVD) products.- IQVIA MedTech’s focused expertise meets the growing needs of device Sponsors to justify product safety and effectiveness as well as reimbursement and adoption challenges due to increased scrutiny by regulators, end-users, and...
-
Local Start-up Specialist, Fra
il y a 2 semaines
Paris, France Allucent Temps pleinThe Local Start-up Specialist (LSUS) coordinates and performs local site start-up activities of Allucent Study Start-up & Site Intelligence. This position executes essential document collection, Regulatory Authority (RA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities. The LSUS may also perform site...
-
Rgulatory and Start Up Specialist
Il y a 2 mois
Paris, France Novasyte Temps pleinJob Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. _French and English Fluent._ Essential Functions -...
-
Study Start Up Specialist
il y a 5 jours
Paris, France TFS HealthScience Temps pleinOverview: TFS HealthScience is excited to be expanding our **Study Start Up **team and we are looking for an experienced, highly motivated **Study Start Up Specialist (SSU Sp)** who shares our vision of providing clinical research excellence. Our **Study Start Up **team is a highly experienced international group of professionals led by an industry...
-
Start Up Assistant
il y a 3 semaines
Paris, France ICON plc Temps pleinStart Up Assistant At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability &...
-
Global Regulatory Manager
il y a 2 semaines
Paris, France Allucent Temps pleinAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Global Regulatory Manager (GRM) to join our A-team (hybrid*/remote). The Global Regulatory Manager is responsible for managing...
-
Global Regulatory Manager
il y a 2 semaines
Paris, France Allucent Temps pleinAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Global Regulatory Manager (GRM) to join our A-team (hybrid*/remote). The Global Regulatory Manager is responsible for managing...
-
Study Start Up Lead
il y a 4 heures
Paris, France IQVIA Temps pleinJob Overview Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of the scope of work, budget and resources. Global experience wanted. Essential Functions Oversee the execution of Site Activation (including...
-
Study Start Up Assistant
il y a 2 jours
Paris, France ICON Temps pleinStudy Start Up Assistant - Office Based - Paris At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an...
-
Lead Regulatory Associate
il y a 1 mois
Paris, France Pivotal Temps pleinDESCRIPTION: We have an open position for a LEAD REGULATORY ASSOCIATE to join our Regulatory Unit within the clinical operations department.A Lead Regulatory Associate (LRA) is the contact person for the Sponsor for all regulatory advice and support for the assigned projects. The LRA is responsible for coordinating a team of Regulatory Associates (RAs) in a...
-
Regulatory Submission Manager
il y a 3 jours
Paris, France Excelya Temps pleinCreated in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care. We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging full-service,...
-
Start Up Specialist
il y a 1 mois
Paris, France Resourcing Temps pleinPrise de poste : 23/07/2024 BAC +5 Paris Nombre de postes non défini CDI À négocier **Description du poste et des missions**: Pour l'un de nos clients, un laboratoire international de premier plan, nous recherchons, Start up Specialist & Start up Manager en France - Minimum 1 ans d'expérience en Laboratoire ou CRO - Bonne maîtrise des outils...
-
Start-up Specialist
il y a 2 semaines
Paris, France Business & Decision Life Sciences Temps pleinPrise de poste non définie BAC +3/+4 Paris Nombre de postes non défini CDI À négocier **Description du poste et des missions**: **Business & Decision Life Sciences, CRO partenaire de la transformation digitale, est une société de conseil spécialisée en santé et nous sommes toujours en recherche de nouveaux consultants pour venir enrichir nos...
-
Regulatory Affairs Specialist
il y a 2 semaines
Paris, France Nanobiotix Temps pleinNanobiotix is happy to welcome a CMC manager, regulatory affairs to provide valuable support to our mission to advance groundbreaking nanomedicine solutions. At the forefront of pioneering nanomedicine approaches that could redefine cancer treatment, our team at Nanobiotix is dedicated to creating innovative solutions to impact countless lives across the...
-
Regulatory Affairs Specialist
il y a 2 semaines
Paris, France Nanobiotix Temps pleinNanobiotix is happy to welcome a CMC manager, regulatory affairs to provide valuable support to our mission to advance groundbreaking nanomedicine solutions. At the forefront of pioneering nanomedicine approaches that could redefine cancer treatment, our team at Nanobiotix is dedicated to creating innovative solutions to impact countless lives across the...
-
Regulatory Affairs Specialist
il y a 4 semaines
Paris, France Nanobiotix Temps pleinNanobiotix is happy to welcome a CMC manager, regulatory affairs to provide valuable support to our mission to advance groundbreaking nanomedicine solutions. At the forefront of pioneering nanomedicine approaches that could redefine cancer treatment, our team at Nanobiotix is dedicated to creating innovative solutions to impact countless lives across the...
-
Regulatory Affairs Specialist
il y a 4 semaines
Paris, France Nanobiotix Temps pleinNanobiotix is happy to welcome a CMC manager, regulatory affairs to provide valuable support to our mission to advance groundbreaking nanomedicine solutions. At the forefront of pioneering nanomedicine approaches that could redefine cancer treatment, our team at Nanobiotix is dedicated to creating innovative solutions to impact countless lives across the...
-
Regulatory Affairs Specialist
il y a 2 semaines
Paris, France Nanobiotix Temps pleinNanobiotix is happy to welcome a CMC manager, regulatory affairs to provide valuable support to our mission to advance groundbreaking nanomedicine solutions. At the forefront of pioneering nanomedicine approaches that could redefine cancer treatment, our team at Nanobiotix is dedicated to creating innovative solutions to impact countless lives across the...
-
Regulatory Affairs Specialist
il y a 3 semaines
Paris, France Nanobiotix Temps pleinNanobiotix is happy to welcome a CMC manager, regulatory affairs to provide valuable support to our mission to advance groundbreaking nanomedicine solutions. At the forefront of pioneering nanomedicine approaches that could redefine cancer treatment, our team at Nanobiotix is dedicated to creating innovative solutions to impact countless lives across the...
