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.
**Hybrid - in office 3x a week.**
**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
-
Regulatory Start Up Intern
il y a 3 semaines
Courbevoie, France IQVIA Temps pleinThe IQVIA Research and Development Solutions team is focused on helping our healthcare customers to find innovative treatments solutions for patients with the common, large or rarest illnesses. To be part of the Regulatory & Start-Up team will help them to decrease the site activation time and help the site to be ready to recruit patients faster. We seek...
-
Regulatory Risk Manager
Il y a 7 mois
Courbevoie, France HSBC Temps plein-Job description At HSBC, we’re a trusted international organisation with a global customer base of around 39 million customers worldwide through a network that covers 62 countries and territories. In Europe, our ambition is to become the leading international wholesale bank and we need talent like you to help us meet our ambition. Whether you want a...
-
Start-up Account Manager
Il y a 7 mois
Courbevoie, France AWS EMEA SARL (France Branch) Temps pleinTechnology related sales or business development experience - Ability to build and deliver against a plan for your territory which meets or exceeds revenue targets - Entrepreneurial “builder” mentality - Excellent French & English verbal and written communication skills - Comfortable delivering results amid ambiguity and change As a Startup Account...
-
Start-up Account Manager
Il y a 7 mois
Courbevoie, France AWS EMEA SARL (France Branch) Temps pleinTechnology related sales or business development experience - Ability to build and deliver against a plan for your territory which meets or exceeds revenue targets - Entrepreneurial “builder” mentality - Excellent French & English verbal and written communication skills As a Startup Account Manager, you will help to acquire and support the growth of...
-
Clinical Operations Manager
Il y a 7 mois
Courbevoie, France IQVIA Temps plein**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. **Fluent in French and English.** **Essential Functions** - Oversee the execution of Site Activation...
-
Non-financial Risk Regulatory Remediation
Il y a 9 mois
Courbevoie, France HSBC Temps plein-Job description The role of the Subject Matter Expert for Non-Financial risk is to provide qualitative answers to ECB requests (SREP, follow up of findings from On Site Inspections) in due time. The role holder will propose and monitor action plans to meet ECB expectations. The role holder will be accountable for validating the changes and preparing the...
-
Business Financial Crime and Regulatory Risk
Il y a 7 mois
Courbevoie, France HSBC Temps plein-Description de l'emploi Doté d’environ 3 000 milliards de dollars d’actifs et opérant dans 62 pays, le Groupe HSBC est l’un des plus grands groupes de services bancaires et financiers dans le monde. Nous sommes plus de 226 000 collaborateurs à accompagner chaque jour 39 millions de clients. En Europe, notre ambition est de devenir la banque...
-
Clinical Trials Co-ordinator
il y a 2 semaines
Courbevoie, France IQVIA Temps pleinExternal Job Description This role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. Assist with daily workload planning. **Trial and site administration**: - Manage SIP, Track (e.g. essential documents) and report (e.g. Safety Reports) - Ensure collation and...
-
Sr Cta
il y a 2 semaines
Courbevoie, France IQVIA Temps pleinThis role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. Assist with daily workload planning. This is a **Hybrid** role - office based in **Paris** **Trial and site administration**: - Manage SIP, Track (e.g. essential documents) and report (e.g. Safety...
-
Grpa Manager
Il y a 5 mois
Courbevoie, France HSBC Temps plein-Description de l'emploi At HSBC, we’re a trusted international organization with a global customer base of around 39 million customers worldwide through a network that covers 62 countries and territories. In Europe, our ambition is to become the leading international wholesale bank and we need talent like you to help us meet our ambition. Whether you...
-
Finançier Part-Time pour Start-up Dynamique
il y a 4 semaines
Courbevoie, Île-de-France KPMG Temps pleinÀ propos de l'offreFonctionnant en parfaite synergie avec notre équipe, vous exercerez les responsabilités suivantes :* Gestion du cash et prévision des flux financiers pour soutenir la croissance de nos clients PME et start-up.* Développement d'un reporting performant et d'un suivi des indicateurs clés pour optimiser les performances financières.*...
-
Finl Control
il y a 2 semaines
Courbevoie, France HSBC Temps pleinRole responsibilities: - Preparation of regulatory reporting returns (RWA, Country Exposure) within the scope of the local reporting to the Autorité de Contrôle Prudentiel / European Central Bank, Banque de France and consolidated reporting to the Prudential Regulation Authority (PRA) for HBEU and Group in a timely manner and to a high standard; -...
-
CFO Part-Time Start up F/H
Il y a 3 mois
Courbevoie, France KPMG Temps pleinVos challengesAu sein d'une belle équipe de CFO-CG-RAF Part-time, vous intervenez auprès d'une clientèle de PME et start-up dynamiques et ambitieuses. Les principaux sujets sur lesquels vous pouvez être amené à intervenir : * Cash Management : prévisionnels de trésorerie, plan de financement, optimisation du BFR * Mise en place de reporting et de...
-
Junior Clinical Research Associate
Il y a 5 mois
Courbevoie, France IQVIA Temps pleinJob Overview Engage in structured training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements. Essential Functions - Complete appropriate therapeutic, protocol and clinical research...
-
Experienced Cra
Il y a 7 mois
Courbevoie, France IQVIA Temps plein**Job Overview** Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. This role requires fluency in the English language. **Essential Functions** - Perform site monitoring visits (selection,...
-
Clinical Research Associate Internship
Il y a 3 mois
Courbevoie, France IQVIA Temps plein**CRA Internship - Office Based Paris** **IQVIA Offers fantastic opportunity for Graduates and Professionals who wish to become a CRA.** By joining IQVIA as CRA Intern you will engage in structured training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating...
-
Risk Remediation, Traded and Treasury Risk
il y a 2 semaines
Courbevoie, France HSBC Temps pleinRole Purpose The role of the Subject Matter Expert of economic capital, traded and treasury matters is to provide qualitative answers to ECB requests (obligations, inspections) in due time. The role holder will propose and monitor action plans to meet ECB expectations. The role holder will be accountable for validating the changes and preparing the...
-
Fsp - Trial Manager - France
Il y a 2 mois
Courbevoie, France IQVIA Temps pleinProvide global, regional or complex local management of a clinical trial (s) (or Medical Affairs data generation activity) in a country or countries. Services/deliverables include operational oversight of assigned project(s) at the country level for end-to[1]end project management including start-up, execution, close-out, analysis and reporting. Further,...
-
Clinical Trials Coordinator- Based in Paris
Il y a 7 mois
Courbevoie, France IQVIA Temps plein**Join us in our exciting journey!** We currently require a motivated and enthusiastic clinical trials professional to join our rapidly growing international division as a Clinical Trials Coordinator. Our client is one of the TOP 5 pharmaceutical companies who is dedicated and passionate about improving the lives of patients across several therapeutic...
-
Financial Crime and Compliance Capabilities
il y a 3 semaines
Courbevoie, France HSBC Temps pleinAvec des actifs d’environ 3 000 milliards de dollars et opérant dans 64 pays, le Groupe HSBC est l’un des plus grands groupes de services bancaires et financiers dans le monde. Le Groupe HSBC compte plus de 40 millions de clients et environ 226 000 employés dans le monde. La stratégie du Groupe repose sur quatre piliers : se concentrer sur nos points...
