Senior Early Stage Studies Assistant

il y a 2 semaines

Brussels, Belgique MSD Temps plein

The incumbent is responsible for hybrid operational support including clinical trial logistics and compliance with essential documents and study milestone reports as well as the execution and support of clinical grants and agreements.

This hybrid operational function includes, but is not limited to:

- operational project support to the Early Stage Development Scientist, responsibility for in-house operational activities in compliance with our processes to initiate, execute and close out early stage clinical trials
- clinical trial agreements and study or study related budgets (planning, negotiation and maintenance), clinical grants payments and procurement activities to support clinical study programs

Essential tasks include, but are not limited to:

- Assemble and provide support for timely Clinical Trial Submissions
- Update, maintain Essential Documents Repository (“Trial Master File”); Assemble and track availability of all essential documents required for study conduct
- Responsible for periodic in-house reconciliation of all essential documents in the electronic Trial Master File
- Update, maintain and monitor Clinical Trial Management System to allow accurate project management and regulatory reporting
- Follow-up on release, return and destruction of Investigational Medicinal Product
- Set-up of blood/urine samples shipments
- Follow-up on ancillary supplies shipments
- Review compliance of site staff vs non study specific training requirements

Contracts Analyst activities:

- Review budgets in context (review budget vs protocol and agreement) and request documented approvals to allow timely regulatory submissions
- Prepare and execute Clinical Study Agreements based on approved templates
- Reconciliation of clinical study budgets
- Track clinical grant costs/payments versus contracts and payment milestones, execute payments
- Verify and generate grant payments/vouchers for investigator site and vendor payments
- Execute purchase orders and payment requests as required
- Run anti-bribery, denied persons screening checks and fact finding
- Obtain and follow-up Financial Disclosure as needed
- Generate and maintain/track disclosure agreements
- Assist in the review of Master Service Agreements and maintain agreements and price lists, in close collaboration with site or vendor, sr contracts analyst, manager, procurement, legal and other stakeholders as needed
- Use the company Grant Systems, SAP/COMET, ARIBA
- Support vendor relationship tasks / assignments with preferred suppliers and sites, process purchase orders, check and track invoicing
- Request and track other payments as needed
- Update and maintain data for benchmarking of study and sourcing costs
- Develops in and maintains direct working relationships with:

- HQ research procurement and global site agreements
- Site clinical and business staff, field monitoring staff
- country financial, clinical and legal departments, procurement

Your profile:

- Work experience in clinical research is an asset
- Understanding and knowledge of study protocols and study working documents, lab manuals, clinical study data etc.
- Interest in operational and financial aspects of clinical trials operations
- Bachelor or Master’s degree
- Very focused and detail and task oriented
- Excellent interpersonal skills and oral and written communication skills
- Data, spreadsheet, computer hardware/software proficiency, knowledge of excel
- Project and time management skills
- Good judgment, follow up and follow through
- Problem solving and decision making skills required

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R266151

  • Early Stage Studies Assistant

    il y a 3 semaines

    Brussels, Belgique MSD Temps plein

    The employee will be delivering support to the Early Stage Development Europe Operational team. He/she will be providing operational support and project support (responsible for in-house activities as well as for compliance with processes required to initiate, maintain, support and close out the early stage clinical trials managed by the department) and will...

  • Senior Scientist Early Stage Development

    il y a 1 semaine

    Brussels, Belgique MSD Temps plein

    Do you have a Master’s or Ph.D. degree in Life Sciences and at least 3 years of experience in monitoring clinical studies and/ or clinical study project management in a pharmaceutical or CRO environment? Are you science driven, autonomous, innovative and team-oriented? Do you want to be part of a team, that pushes the boundaries of global healthcare...

  • Senior Scientist Clinical Research

    il y a 2 heures

    Brussels, Belgique MSD Temps plein

    Do you have a Master’s or Ph.D. degree in Life Sciences and at least 3 years of experience in monitoring clinical studies and/ or clinical study project management in a pharmaceutical or CRO environment? Are you science driven, autonomous, innovative and team-oriented? Do you want to be part of a team, that pushes the boundaries of global healthcare...

  • Senior Scientist Clinical Research

    il y a 2 heures

    Brussels, Belgique MSD Temps plein

    **Job Description**: - Do you have a Master’s or Ph.D. degree in Life Sciences and at least 3 years of experience in monitoring clinical studies and/ or clinical study project management in a pharmaceutical or CRO environment? Are you science driven, autonomous, innovative and team-oriented? Do you want to be part of a team, that pushes the boundaries of...

  • Stage Buying Assistant

    il y a 3 semaines

    Brussels, Belgique LolaLiza Temps plein

    As an **intern Buying Assistant** you will support our Buying team on all commercial and production activities. Are you an organizational and administrative talent? Do you have a clear commercial sense? Do you have an affinity with fashion? Then our internship opportunity might be something for you! **DURING YOUR INTERNSHIP YOU WILL BE RESPONSIBLE FOR THE...

  • Assistant Commercial

    il y a 1 semaine

    Brussels, Belgique Wonderbox Temps plein

    **Votre mission ?** Dans le cadre de notre développement, nous recherchons **un Assistant commercial (M/F) pour un stage de 6 mois en Belgique (Bruxelles).** Rattaché(e) au service Sourcing (et relation partenaires), vous travaillerez avec le responsable sourcing. Vos missions seront les suivantes: - Vous aiderez avec le lancement d'une nouvelle carte...

  • Associate Principal Early Stage Development

    il y a 2 semaines

    Brussels, Belgique MSD Temps plein

    The incumbent will be responsible for clinical trial operational execution of Early Stage Trials (also known as phase 1 trials) in Europe in close collaboration with the ESD Operations Lead. This includes overseeing operational efforts supporting multiple therapeutic areas, ensuring quality and ontime execution of all Translational Medicine (TMED) EU managed...

  • Assistant Contrôleur de Gestion

    il y a 2 semaines

    Brussels, Belgique Robert Half Belgium Temps plein

    Robert Half est à la recherche **d'un assistant contrôleur de gestion (H/F/X)** pour une mission intérimaire en vue d'un contrat à durée indéterminée. Robert Half est à la recherche ** d'un assistant contrôleur de gestion (H/F/X)** pour une mission intérimaire en vue d'un contrat à durée indéterminée. Notre client est une société active...

  • Stage SEO

    il y a 2 semaines

    Brussels, Belgique HDM Network. Temps plein

    **Présentation de l'entreprise**: Service RH d'une plateforme active dans la mise en relation de particuliers avec des professionnels de la construction et de la rénovation. **Descriptif du poste**: - Société : _ **HDM Network.** - Catégorie : _ **Stage** - Activité : _ **Services** - Filiere : _ **Marketing** - Metier : _ **Assistante Marketing** -...

  • Senior Eu Affairs Advisor

    il y a 3 semaines

    Brussels, Belgique Vodafone Temps plein

    **Senior EU Affairs Advisor - EU Funds**: **Location: Brussels** The** **Senior EU Affairs Advisor conducts monitoring and policy/economic analysis in support of policy development or new policy creation, ensuring Group and/or Local market/s are aware of draft or current EU/government legislation and/or regulation that impacts Vodafone. They oversee...

  • Clinical Trial Operational Assistant

    il y a 2 semaines

    Brussels, Belgique MSD Temps plein

    As part of a dynamic and passionate team, this specialist is responsible for hybrid operational support in phase 1 early stage clinical trials across Europe.. This hybrid operational function includes, but is not limited to: - operational project support to the Early Stage Development Scientist, responsibility for in-house operational activities in...

  • Stage -assistant (E) Sales Administration (H/F)

    il y a 4 semaines

    Brussels, Belgique Bulgari Temps plein

    Position **Présentation de l'entreprise**: Fondée en 1884, le joaillier italien Bvlgari s'est progressivement imposé comme emblème de l'excellence italienne et compte parmi les acteurs majeurs du secteur du luxe. Forte de la réussite et de l'esprit pionnier de la famille Bulgari, la Maison évolue aujourd'hui sur la scène internationale. Ses racines...

  • HR Assistant

    il y a 2 semaines

    Brussels, Belgique Intelect Temps plein

    Ben je op zoek naar een interne Hr-functie waar de focus ligt op harde HR maar waar je toch nog een breed takenpakket krijgt? Zoek niet verder! Als HR Assistant kom je terecht in een hecht HR team in dit internationaal bedrijf. Je kan rekenen op je collega's voor opleiding, maar je kan ook zelfstandig aan de slag en krijgt een uitgebreid takenpakket. Je...

  • Assistant Hse

    il y a 2 semaines

    Brussels, Belgique Ecofrost Temps plein

    Emploi fixe employé Agent de sécurité ICT (IT) - réseau Assistant HSE Électromécanicien All round problem solver Responsable QHSE Assistant achat matières premières Étudiants Job étudiant Stagiaires Stage en production call-to-dect Stage en comptabilité Stage en IT réseau et help-desk Stagiaire en scannage - IT Cartonneur Stage en ressources...

  • Assistant RH

    il y a 3 semaines

    Brussels, Belgique Robert Half Belgium Temps plein

    Pour notre client, Robert Half recherche un **Assistant RH (H/F/X)**. Il s'agit d'une mission d'intérim en vue d'engagement. Pour notre client, Robert Half recherche un **Assistant RH (H/F/X)**. Il s'agit d'une mission d'intérim en vue d'engagement. Notre client est situé en région liégeoise et est actif dans le secteur de la construction. **Dans le...

  • Assistant RH

    il y a 2 heures

    Brussels, Belgique Ecofrost Temps plein

    Emploi fixe employé Junior planner Junior logistique Assistant RH Responsable HSE Électromécanicien Customer care assistant Young graduates traineeship Assistant supply chain Comptable Étudiants & stagiaires Stage en comptabilité Stage en IT réseau et help-desk Job étudiant Stage en ressources humaines Stage - GMAO ISO GREEN LABEL Nettoyeur...

  • Stage Arbeidsongeval

    il y a 2 semaines

    Brussels, Belgique P&V Group Temps plein

    Binnen het team claims arbeidsongevallen in Brussel zijn wij op zoek naar een enthousiaste stagiair. Tijdens de stage zal je actief deel uitmaken van het team en voer je diverse taken uit die jou toevertrouwd worden. Je hebt een ondersteunende rol en je kan evolueren naar een actieve rol, afhankelijk van je betrokkenheid en capaciteiten. Wij bieden je de...

  • Executive Assistant

    il y a 1 semaine

    Brussels, Belgique Robert Half Temps plein

    Robert Half is momenteel op zoek naar een **Executive Assistant (m/v/x)**. Vind je het leuk om zakelijke bijeenkomsten te coördineren en te organiseren? Heb je al enige ervaring in het bijstaan van senior executives? Jongleer jij nauwkeurig met een veelheid aan taken zonder je prioriteiten te verliezen? Dan is deze baan waarschijnlijk iets voor jou. **Als...

  • Stage ou Vie

    il y a 3 semaines

    Brussels, Belgique Greenfish Temps plein

    Vous êtes à la recherche d'un réel challenge ? Vous êtes prêt à accompagner le développement d'une entreprise jeune et dynamique ? Vous avez une conscience environnementale et désirez oeuvrer pour un futur durable ? Il s'agit peut-être de l'opportunité que vous cherchez ! Greenfish est une société experte en ingénierie, nous accompagnons et...

  • Stage / Internship Assistant Brand Manager

    il y a 3 semaines

    Brussels, Belgique JACOBS DOUWE EGBERTS Temps plein

    Stage / Internship Assistant Brand Manager - Trainee - & Internships - BRUSSELS - Intern - Belgium Jacobs Douwe Egberts (JDE) is the world's leading pure-play coffee and tea company. For more than 265 years, JDE has been inspired by the belief that it’s amazing what can happen over a cup of coffee. Today, JDE unleashes the possibilities of coffee and tea...