Reg & Start Up Manager - Netherlands

1 maand geleden

Amsterdam, Nederland IQVIA Voltijd

**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 Dutch - Hybrid role.
- **

**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

  • Project Manager, Start-up

    6 maanden geleden

    Amsterdam, Nederland NLF Fortrea Netherlands BV Voltijd

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Senior Business Development Manager Netherlands

    4 weken geleden

    Amsterdam, Noord-Holland, Nederland Workiva Netherlands BV Voltijd

    As a Senior Business Development Manager at Workiva Netherlands BV, you will play a crucial role in driving sales growth and expanding our customer base in the Dutch market. With your strong business acumen and ability to understand complex business challenges, you will identify new sales opportunities and build relationships with executive-level buyers and...

  • Logistics Operations Manager

    4 weken geleden

    Amsterdam, Noord-Holland, Nederland Mover Systems Voltijd

    Mover Systems is revolutionizing the logistics industry, and we're looking for a talented Logistics Operations Manager to join our team in the Netherlands.About Mover SystemsWe're a Danish scale-up technology company with IKEA as a partner and shareholder. Our 70+ professionals are making a real impact in an industry crucial to both the global economy and...

  • Operations Manager, Netherlands

    2 maanden geleden

    Amsterdam, Nederland GENLED Brands Voltijd

    Operations Manager, Netherlands Company Address: De Corridor 16L en 16K, 3621ZB Breukelen The Operations Manager, Netherlands oversees our inventory and supply chain for the European market and supervises our supply chain planning and warehouse staff at our GENLED Brands facility in the Netherlands. This role requires an individual with strong...

  • Project Portfolio Manager

    1 week geleden

    Amsterdam, Nederland Unilabs Voltijd

    Unilabs, a leading provider of diagnostic services, is seeking a Project Portfolio Manager to join our dynamic team in the Netherlands. As an innovative and customer-focused company, we are committed to delivering the highest quality diagnostic services to our clients. As the Project Portfolio Manager, you will work with project managers to plan project...

  • Finance Manager Netherlands

    1 maand geleden

    Amsterdam, Nederland Blink Charging Voltijd

    Blink Charging is een geïntegreerde wereldwijde fabrikant, eigenaar, installateur en uitbater van oplaadoplossingen voor elektrische voertuigen. **Finance Manager Netherlands & New Markets**: **Houd jij van complexe uitdagingen en krijg je energie van bouwen aan iets nieuws? Weet jij hoe je een stevig financieel fundament legt en structuren schaalbaar...

  • Residential Flooring Account Manager

    3 weken geleden

    Amsterdam, Noord-Holland, Nederland CPJ Recruitment Voltijd

    Account Manager Opportunity in the NetherlandsWe are seeking a highly skilled and experienced Account Manager to join our client's team in the Netherlands. As an Account Manager, you will play a crucial role in developing commercial relationships with independent flooring retailers, enhancing brand development, and driving revenue growth.About the Role:This...

  • Human Resources Business Partner

    2 maanden geleden

    Amsterdam Centrum, Nederland Retailors Netherlands B.V. Voltijd

    **Human Resources Business Partner (HRBP) Netherlands** Retailors is a leading, fast growing retailor, specializing in the sports, athleisure segment and is a global partner of choice to operate Nike retail locations in Europe, Canada Australia, New Zealand and Israel. Due to our extraordinary success and expansion plans in Europe we are looking for an...

  • IT Support Expert for Climate Tech Start-up

    2 weken geleden

    Amsterdam, Noord-Holland, Nederland SKYTREE B.V Voltijd

    About Skytree B.V.">We are a cutting-edge climate tech start-up based in the Netherlands, dedicated to developing and deploying innovative technologies that capture atmospheric carbon dioxide. Our team of talented scientists, engineers, and business professionals is passionate about creating a cleaner air future for everyone.Our company culture values...

  • "Ben jij een ervaren Accountmanager voor een duurzame en innovatieve start-up?"

    1 maand geleden

    Amsterdam, Noord-Holland, Nederland Independent Recruiters Voltijd

    Ben jij onze nieuwe Accountmanager?We zijn een duurzame en innovatieve start-up op zoek naar een ervaren Accountmanager. Als specialist in rekeninghouding word je verantwoordelijk voor het ontwikkelen en realiseren van accountplannen, het identificeren van nieuwe businesskansen en het sluiten van deals.Je taken:Ontwikkelen en realiseren van...

  • Senior Public Affairs Manager Netherlands

    4 weken geleden

    Amsterdam, Noord-Holland, Nederland Gilead Sciences Netherlands BV Voltijd

    At Gilead Sciences, we are a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need.We are seeking a highly skilled Senior Public Affairs Manager to join our team in the Netherlands. This role will be responsible for corporate and brand communications of the BeNeLux cluster...

  • PPE Business Development Manager Netherlands

    3 weken geleden

    Amsterdam, Noord-Holland, Nederland Lyreco Group Voltijd

    About the RoleWe are seeking an experienced PPE Business Development Manager to join our team in the Netherlands. In this role, you will be responsible for driving sales growth and market penetration in the corporate sector while improving profitability.As a key member of our Sales Management Team, you will lead a team of Sales Managers and Account Managers...

  • Account & Recruitment Manager - Netherlands

    4 weken geleden

    Amsterdam, Nederland PM Group Voltijd

    Overview PM Group is a leading International engineering, architecture, project and construction management firm. With a network of offices in Europe, Asia and the US and a multi-discipline team of more than 3,700 people, we deliver complex capital projects in the pharma, life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy...

  • Account & Recruitment Manager - Netherlands

    2 maanden geleden

    Amsterdam, Noord-Holland, Nederland PM Group Voltijd

    Overview PM Group is a leading International engineering, architecture, project and construction management firm. With a network of offices in Europe, Asia and the US and a multi-discipline team of more than 3,700 people, we deliver complex capital projects in the pharma, life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy...

  • Service Delivery Manager

    3 maanden geleden

    Amsterdam, Nederland Blue Wireless Voltijd

    Blue Wireless is a global leader in providing Wireless Network Solutions for Global Enterprises. With global coverage in over 80 countries, we are transforming the way LTE/5G and Starlink technology is used for connect branches, remote sites and vessels using wireless solutions. Headquartered in Singapore with local operations in Australia, Malaysia,...

  • Regulatory and Start Up Manager

    6 maanden geleden

    Amsterdam, Nederland IQVIA Voltijd

    **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 Dutch and English.** **Essential Functions** - Oversee the execution of Site Activation...

  • Sales Development Manager

    3 weken geleden

    Amsterdam, Noord-Holland, Nederland Smith+Nephew Voltijd

    Unlock the Potential of Sales in Central Netherlands At Smith+Nephew, we design and manufacture technology that takes the limits off living. As a Sales Development Manager in Central Netherlands, you will be responsible for building real and meaningful relationships with our customers, developing a strategy to provide the best possible service, and...

  • Technical Sales Manager

    3 maanden geleden

    Amsterdam, Nederland IC Resources Voltijd

    Technical Sales Manager - Semiconductor Distribution – Netherlands An experienced Technical Sales Engineer/Sales Manager required to join a reputable franchised electronics distributor that represent major semiconductor and electronic component manufacturers across Europe. Suitable candidates will have an electronics qualification and proven demand...

  • Manager Capital Management

    4 weken geleden

    Amsterdam Westpoort, Nederland Athora Netherlands Voltijd

    **Do you want to take part of the Athora Netherlands' dynamic capital management environment? Do you want to make a difference and help the optimal use of capital?** **About Athora** Athora Netherlands is one of the largest pension insurers in the Netherlands. With our brands Zwitserleven and Reaal, we take care of the financial security of our customers....

  • Financieel Expert bij Jonge Start-up

    4 weken geleden

    Amsterdam, Noord-Holland, Nederland YoungCapital Voltijd

    Company OverviewWij zijn op zoek naar een financieel expert die onze snelgroeiende jonge start-up wil helpen om leningen eerlijker en transparanter te maken voor consumenten.SalarisJe kunt je verwachten tot een salaris van €2700 - €3100 bruto per maand afhankelijk van jouw ervaring.FunctieomschrijvingAls financieel expert in Amsterdam beoordeel je nieuwe...