Senior Start-up Specialist

il y a 5 jours

SintLambrechtsWoluwe, Belgique Labcorp Temps plein

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Labcorp Drug Development client’s policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the SCOM or CRD, the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready.

**Essential Job Duties**:

- Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).
- Oversees and tracks clinical research-related payments. Payment reconciliation at study close-out. Oversees FCPA, DPS/OFAC, and maintenance of financial systems. Financial forecasting in conjunction with SCOM /other roles.
- Executes and oversees clinical trial country submissions and approvals for assigned protocols.
- Develops local language materials including local language Informed Consents and translations. Interacts with IRB/IEC and Regulatory Authority for assigned protocols.
- Manages country deliverables, timelines and results for assigned protocols to meet country commitments. Responsible for quality and compliance in assigned protocols in country.
- Contributes to the development of local SOPs. Oversees CTCs as applicable.
- Coordinates and liaises with CRM, CTC, CRA, (Finance and Legal if appropriate) to ensure country deliverables are obtained for submissions, budgets, CTRAs and local milestones.
- Collaborates closely with Headquarter to align country timelines for assigned protocols.
- Provides support and oversight to local vendors as applicable.
- Ownership of local regulatory and financial compliance. The position has a significant impact on how a country can deliver country-specific trial commitments and objectives especially during study start-up.
- Required to in/directly influence investigators, external partners and country operations to adhere to partners and country operations to adhere to budget targets and agreed payment timelines.
- Works in partnership internally with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and sites, IRB/IECs and Regulatory Authorities in submission and approval related-interactions. Through continual interaction with local clinical team/s successfully delivers clinical and financial contracts within fair market value.
- Oversees and coordinates local processes, clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving and retention requirements, and insurance process management. Enters and updates country information in clinical and finance systems.

**Experience**:

- 5 years of experience in clinical research or combined experience in Clinical Research and Finance/Business

**Education/Qualifications/Certifications and Licenses**:

- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).
- Expertise of core clinical systems, tools and metrics
- Excellent English skills
- Strong coordination and organizational skills
- Skilled knowledge of budget and contract negotiations, local regulatory environment and submission and approval processes, and understanding of how these impact study start-ups
- Ability to indirectly influence investigators, vendors, external partners and country managers to address and resolve issues, with mínimal support from the SCOM or manager.
- Ability to make decisions independently with limited oversight from SCOM or manager.
- Requires strong understanding of local regulatory environment
- Ability to proactively develop risk management and mitigation plans in the country and resolve issues locally.

**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

For more information about how we collect and store your personal data, please see our Privacy Statement.

  • Start Up Specialist

    il y a 3 semaines

    Sint-Lambrechts-Woluwe, Belgique Labcorp Temps plein

    Are you someone with previous regulatory submissions experience looking for developing your career within this area? With the support of exceptional people and an energized purpose, you’ll be empowered to own your career journey with dedicated mentoring, training and personalized development planning. **Education/Qualifications** - University/college...

  • Boutique Coffee Specialist

    il y a 6 jours

    Sint-Lambrechts-Woluwe, Belgique Nestle Temps plein

    **Position Summary** - Where will you work? Nespresso boutique Louise & Woluwe - When will you start? ASAP - Type of contract: full time permanent contract We are currently looking for a Coffee Specialist. The Boutique Coffee Specialist will act as an ambassador for the Nespresso brand in the boutique welcoming, advising, and guiding clientele in their...

  • Senior Tax Officer

    il y a 3 jours

    Sint-Lambrechts-Woluwe, Belgique BESIX GROUP Temps plein

    Functieomschrijving Functieomschrijving We are looking for a Senior Tax Officer to focus on (Belgian) corporate tax and transfer pricing compliance. The role is based in Brussels, within our Global Headquarters. Reporting to the Group Tax Director, you will have the following responsibilities: - Supervising, securing and monitoring the tax compliance of...

  • Customer Loyalty Specialist

    il y a 4 semaines

    Sint-Lambrechts-Woluwe, Belgique UNITED PARCEL SERVICE Temps plein

    Explore your next opportunity at a Fortune Global 500 organization. Envision innovative possibilities, experience our rewarding culture, and work with talented teams that help you become better every day. We know what it takes to lead UPS into tomorrow—people with a unique combination of skill + passion. If you have the qualities and drive to lead yourself...

  • Marketing Specialist

    il y a 2 jours

    Sint-Stevens-Woluwe, Belgique Arrow Electronics Temps plein

    **Position**: Marketing Specialist**:**Principal Accountabilities** - Responsible for the development of aligned marketing plans with vendors (and partners) - Interfacing with Product Vendors incl. quarterly planning, business reviews and attending regular vendor & customer calls/meetings - Align with the different marketing strategies of the vendors and...

  • Senior AP Specialist

    il y a 17 heures

    Sint-Katelijne-Waver, Flandre, Belgique Robert Half Belgium Temps plein

    Onze klant, een vooraanstaande leverancier van groenten en fruit, met hoofdkantoor in Sint-Katelijne-Waver en actief in meer dan 20 landen, is op zoek naar een Senior AP Specialist om hun dynamisch team te versterken. Dit bedrijf heeft diverse afdelingen, gaande van conserven tot logistiek en transport.Kernverantwoordelijkheden:Zorgen voor tijdige...

  • Customer Communications Specialist

    il y a 7 jours

    Sint-Lambrechts-Woluwe, Belgique UNITED PARCEL SERVICE Temps plein

    Explore your next opportunity at a Fortune Global 500 organization. Envision innovative possibilities, experience our rewarding culture, and work with talented teams that help you become better every day. We know what it takes to lead UPS into tomorrow—people with a unique combination of skill + passion. If you have the qualities and drive to lead yourself...

  • Support Content Developer

    il y a 2 semaines

    Sint-Lambrechts-Woluwe, Belgique Pauwels Consulting Temps plein

    **Job description**: - For our pharmaceutical client in Brussels, we're looking for a **Junior Support Content Developer**. As Junior Developer the following responsibilities will be yours: - Designing and building the webpages with the existing MSD WP theme. - Creating the website architecture & configure plug-ins. - Conducting website performance...

  • Vendeur Boutique Woluwé

    il y a 4 semaines

    Sint-Lambrechts-Woluwe, Belgique Start People Temps plein

    Pour un renforcer l'équipe de vente: En tant que Sales Advisor vous êtes représentant(e) (M/V) de la politique commerciale et de la nouvelle image de Damart. Vous détectez les besoins des clients et prêtez conseil d’une façon professionnelle tout en y apportant votre touche personnelle. Le client est à tout moment le centre de votre processus de...

  • Vendeur Boutique Renfort Hiver Woluwé

    il y a 3 semaines

    Sint-Lambrechts-Woluwe, Belgique Start People Temps plein

    Pour un renforcer l'équipe de vente **de septembre à décembre**: En tant que Sales Advisor vous êtes représentant(e) (M/V) de la politique commerciale et de la nouvelle image de Damart. Vous détectez les besoins des clients et prêtez conseil d’une façon professionnelle tout en y apportant votre touche personnelle. Le client est à tout moment le...

  • Shopmanager Damart

    il y a 3 semaines

    Sint-Lambrechts-Woluwe, Belgique Start People Temps plein

    Représentant(e) de la politique commerciale et de la nouvelle image de Damart, vous dynamisez votre point de vente (résultats, merchandising, mise en valeur des produits), tout en garantissant le meilleur conseil et service à nos clients. - Vous êtes responsable de la direction opérationnelle quotidienne du magasin dans l’établissement du planning de...

  • Développeur Python Senior

    il y a 2 semaines

    Sint-Lambrechts-Woluwe, Belgique Sewan Temps plein

    Description de l'entreprise D’une petite start-up basée dans une ancienne boulangerie à un groupe européen, les choses ont bien changé depuis 15 ans. Créée en 2007 par quatre entrepreneurs issus du milieu des télécoms, Sewan est née d’un constat. Les entreprises rencontrent encore trop de complexité dans leur transition numérique. C’est avec...

  • Field Underwriter Fleet

    il y a 3 semaines

    Woluwe-Saint-Lambert, Région de Bruxelles, Belgique Axis Group - HR Advisor Temps plein

    Are you a seasoned Underwriter with a passion for taking the fleet insurance sector to new heights? Our client, a renowned corporate insurer specializing in tailor-made solutions across various industries, is seeking a proactive Senior Underwriter Fleet to join their team in Belgium and Luxembourg.As a Senior Fleet Insurance Specialist, you will have the...

  • Digital Marketing Specialist

    il y a 6 jours

    Sint-Lambrechts-Woluwe, Belgique Devoteam G Cloud Benelux Temps plein

    Company Description Take the next step in your marketing career & become a digital marketer in the high-performing marketing team at Devoteam G Cloud! About our company: Our mission is to build cultures of innovation at companies by transforming the way they work, by modernising their IT infrastructure & apps, and by elevating their customer experiences. As...

  • Electromechanical Automation Specialist

    il y a 1 jour

    Sint-Andries, Belgique CTRL-F Temps plein

    Job OverviewThe position of Electromechanical Automation Specialist at CTRL-F offers an exciting opportunity to join a dynamic team and contribute to the success of our organization.Key Responsibilities:Machine Start-up and TestingAutomation and ConfigurationQuality Assurance and DocumentationCustomer Training and SupportLaboratory...

  • (Senior) Project Manager

    il y a 1 semaine

    Sint-Pieters-Woluwe, Belgique Thermo Fisher Scientific Temps plein

    At PPD Clinical Research Services we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your...

  • Senior Conversational Designer

    il y a 2 semaines

    Sint-Gillis, Belgique AMA European Consulting Temps plein

    Senior Conversational designer Within DESIGN chapter area, the Conversation Design Chapter, creates the dialogs of the Digital Assistant (chatbot and voice IVR), and improves the user experience of customers and answers the digital needs that modern-day consumers have. As a Senior Conversational Designer you will be part of a multi-disciplinary team that...

  • (Senior) Project Mgr

    il y a 1 semaine

    Sint-Pieters-Woluwe, Belgique Thermo Fisher Scientific Temps plein

    PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams. Our Project...

  • Sales Intern

    il y a 2 semaines

    Sint-Lambrechts-Woluwe, Belgique Devoteam G Cloud Belgium Temps plein

    Company Description **Who are we?** Devoteam G Cloud is the Devoteam entity dedicated to Google Cloud technologies. We're a growing team of Google Cloud enthusiasts and are looking for senior profiles to boost our Data & Analytics Tribe. **We Set the pace. We Move together. We go Big! **A bold claim ? As a** Premier Google Cloud partner,** we implement...

  • Marketing Assistant

    il y a 4 jours

    Sint-Lambrechts-Woluwe, Belgique Aspria Belgium Temps plein

    Functieomschrijving Job purpose Maximize all communications' channels to retain members of the Aspria Arts-Loi club and to maximize the secondary spend revenue. Key responsibilities You will be responsible for planning, organizing, and implementing the internal communication plan for Aspria Arts-Loi in line with the agreed business objectives and brand...