Local Start-up Specialist Ii

il y a 2 semaines

Bruxelles, Région de Bruxelles, Belgique Allucent Temps plein

At 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 Local Start Up Specialist II (LSUS) to join our A-team (hybrid*/remote) The 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 contract and budget negotiations and execution of negotiated contracts.

The Local Start-up Specialist II is a member of the Study Start-up & Site Intelligence Unit.

In this role your key tasks will include:

  • Track relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities (as defined below)
  • Ensure planned dates are reliable and up to date in CTMS departments/study teams
  • File documents in the (e)TMF for which they are the document owner
  • Assist other Study Startup team members with filing documents in the (e)TMF for which they are document owner
  • Assist in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials at local level
  • Provide relevant documents in compliance with local regulation
  • Support review of technical, preclinical and clinical reports for regulatory submissions
  • Interact with regulatory authorities
  • Prepare and compile answers for questions raised by the regulatory agencies and submit the answers
  • Regularly check for updates on regulations, guidelines and procedures. Ensure these updates are communicated and circulated as appropriate
  • Support Global Regulatory Manager (GRM) and/or Global Submission Specialist (GSS) as needed
  • Prepare, compile, submit and maintain ethical requirements and documentation required by IEC/IRB for clinical trials at local level
  • Assist in providing and reviewing relevant documents in compliance with ethical requirements and per local legislation
  • Interact with IEC/IRB
  • Prepare and compile answers for questions raised by the IEC/IRB and submit the answers
  • Regularly check for updates on regulations, guidelines, and procedures. Ensure these changes and updates are communicated and circulated as appropriate
  • Assist in adapting country SIS/ISF to sitespecific requirements
  • Provide country specific requirements to GSCM impacting site contracts' process
  • Prepare, review, negotiate, and finalize Clinical Trial Agreements (CTAs), Letter of Indemnification (LOI), termination letters, budgets, and other site level agreements required for a clinical study
  • Negotiate within client approved contract and budget templates and negotiation parameters
  • Communicate with sites and internal personnel regarding the status of contracts and contract related documents
  • Arrange translation of the final country CTA template and/or final negotiated contracts, where applicable
  • Provide the final/draft CTA and site budget for submission, where required
  • Obtain site signature as well as Sponsor/Allucent signature, as applicable
  • Keep up to date with applicable local regulations impacting clinical trial contracts
  • Assist in preparing the sitespecific Essential Document Package and sending to sites

Requirements:

To be successful you will possess:

  • Life Science degree or equivalent qualification or certification in a related allied health profession from an appropriate accredited institution
  • 2+ years of experience in regulatory affairs in the pharmaceutical or biotechnology industry
  • A thorough knowledge of the country or region competent authority submission and reporting requirements and guidelines
  • A thorough understanding of the drug development process
  • Good oral and written communications skills fluent in English and either Dutch or French
  • Attention to detail
  • Able to perform well as a team member

Benefits

Benefits of working at Allucent include:

  • Comprehensive benefits package
  • Competitive salaries per location
  • Departmental Study/Training Budget for furthering professional development
  • Flexible Working hours (within reason)
  • Opportunity for fully remote working or hybrid Working Model
  • Leadership and mentoring opportunities
  • Internal growth opportunities and career progression
  • More task variety
  • Financially rewarding internal Employee Referral Program
  • Access to online softskills and technical training via GoodHabitz and internal platforms

Disclaimers:

  • Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

  • Senior Start Up Specialist Brussels

    il y a 2 semaines

    Bruxelles, Région de Bruxelles, Belgique Resourcing Life Science Temps plein

    Company DescriptionOur client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a Start up Specialist office based in Brussels.Job Overview Responsible for CA & Ethics Committee...

  • Global Clinical Start Up Manager France

    il y a 2 semaines

    Bruxelles, Région de Bruxelles, Belgique Resourcing Life Science Temps plein

    Company DescriptionOur client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a Clinical Start up Manager in FranceJob Overview Leading crossfunctional project teams globally...

  • Global Clinical Start Up Manager Brussels

    il y a 2 semaines

    Bruxelles, Région de Bruxelles, Belgique Resourcing Life Science Temps plein

    Company DescriptionOur client is a Global CRO currently supporting various Pharmaceutical & Biotech companies globally. They offer a full service solution encompassing clinical & non-clinical development, peri-approval & market access. They are currently seeking a Clinical Start up Manager office based in Brussels.Job Overview Leading crossfunctional project...

  • Start-up Manager

    il y a 2 semaines

    Bruxelles, Région de Bruxelles, Belgique Knauf Insulation Western Europe Temps plein

    Who we are:_ KNAUF__INSULATION_**, being part of Knauf Group, has more than 40 years of experience in the insulation industry and houses nearly 6000 employees in more than 40 countries. We are a dynamic company, a brand, a family that cares for and puts the needs of its customers first.Context of the hiring:The role exists to optimise the start-up phase of...

  • Start-up Associate

    il y a 2 semaines

    Bruxelles, Région de Bruxelles, Belgique Fortrea Temps plein

    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...

  • Project Manager, Start-up

    il y a 1 semaine

    Bruxelles, Région de Bruxelles, Belgique Fortrea Temps plein

    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...

  • Talent Acquisition Evolution en Start-up

    il y a 1 semaine

    Bruxelles, Région de Bruxelles, Belgique Sander & Partners Temps plein

    Sander. est une Start-up belge en recrutement et en HR-Tech. Partis de rien il y a presque 3 ans, comptons aujourd'hui une équipe de plus de 17 personnes, +/- 135 partenariats et une croissance annuelle de 160%. Rien que cette année, nous avons accueilli 8 personnes et nous avons lancé notre plateforme digitale.Notre mission est de réinventer le secteur...

  • Teacher in English

    il y a 2 semaines

    Bruxelles, Région de Bruxelles, Belgique ECOLE EUROPEENNE DE BRUXELLES II Temps plein

    The European School Brussels II is looking for: 1 Teacher in English (L2 – L3) 8 periods/week Fixed-term contract The European Schools are an intergovernmental organization offering multilingual and multicultural education. The job consists of teaching English in the secondary cycle as L2 and L3. Excellent command of English. Knowledge of French or German...

  • Teacher Of Chemistry, Teacher Of Ict

    il y a 2 semaines

    Bruxelles, Région de Bruxelles, Belgique Ecole Europeenne De Bruxelles Ii Temps plein

    Teacher in Chemistry-Integrated Sciences-ICT (Lithuanian section)- Teaching chemistry-integrated sciences-ICT in secondary cycle (S1 to S7)- Replacement contract- Perfect command of Lithuanian (native level)- Excellent command of English- Knowledge of French or German is an asset- Teacher's diploma for teaching chemistry-integrated sciences-ICT at secondary...

  • teacher of geography, english teacher

    il y a 1 semaine

    Bruxelles, Région de Bruxelles, Belgique ECOLE EUROPEENNE DE BRUXELLES II Temps plein

    1 English teacher in Geography & Human Sciences 15-17 periods/week Fixed-term contract The European Schools are an intergovernmental organization offering multilingual and multicultural education. The job consists of teaching geography & human sciences in the secondary cycle (S1 to S7, up to the baccalaureate). Excellent command of English (native level)....

  • English teacher in Geography

    il y a 2 semaines

    Bruxelles, Région de Bruxelles, Belgique ECOLE EUROPEENNE DE BRUXELLES II Temps plein

    Looking for an English teacher specializing in Geography & Human Sciences!15-17 periods per weekFixed-term contract until 31/08/2025 (with a possibility of extension)The European Schools, an intergovernmental organization, provide a diverse and multilingual educational experience. The role involves teaching geography & human sciences to students in the...

  • Teacher Of Geography, English Teacher

    il y a 2 semaines

    Bruxelles, Région de Bruxelles, Belgique Ecole Europeenne De Bruxelles Ii Temps plein

    English teacher in Geography & Human Sciences Teach 15-17 periods/week Fixed-term contract The European Schools, an intergovernmental organization, provide multilingual and multicultural education. Job Responsibilities: Teach geography & human sciences in the secondary cycle (S1 to S7, up to the baccalaureate) Requirements: Excellent command of English...

  • Sr Country Approval Specialist

    il y a 2 semaines

    Bruxelles, Région de Bruxelles, Belgique Thermo Fisher Scientific Temps plein

    At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Product Specialist Terminals

    il y a 2 semaines

    Bruxelles, Région de Bruxelles, Belgique Gentis Recruitment Temps plein

    Faites partie d'un groupe international de traitement de paiements par carte, offrant des solutions de paiement en ligne et en magasin.Grâce à leurs projets ambitieux prévus pour les prochaines années, ils recherchent leur nouveau product specialist spécialisé terminaux.- Faites partie d'un groupe international de responsables de produits au sein de...

  • Ass. Project Manager Start-up

    il y a 2 semaines

    Bruxelles, Région de Bruxelles, Belgique Fortrea Temps plein

    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...

  • Teacher

    il y a 2 semaines

    Bruxelles, Région de Bruxelles, Belgique ECOLE EUROPEENNE DE BRUXELLES II Temps plein

    1 Teacher in Chemistry-Integrated Sciences-ICT (Lithuanian section). 22 periods/week - secondary cycle. Replacement contract. The European Schools are an intergovernmental organization offering multilingual and multicultural education. The job consists of teaching chemistry-integrated sciencesICT in the secondary cycle (S1 to S7). Perfect command of...

  • Clinical Research Associate Ii

    il y a 2 semaines

    Bruxelles, Région de Bruxelles, Belgique Precision Medicine Group Temps plein

    Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific...

  • enseignant

    il y a 2 semaines

    Bruxelles, Région de Bruxelles, Belgique ECOLE EUROPEENNE DE BRUXELLES II Temps plein

    De Europese School Brussel II zoekt een wiskundeleraar voor de Nederlandstalige sectie van de secundaire cyclus. 21 lesuren per week Contract van bepaalde duur Meertalig en multicultureel onderwijs Deze functie omvat het geven van wiskunde in het secundair onderwijs (S1 tot S7). Ideale kandidaat is een native Nederlandstalige met goede kennis van Frans....

  • Cra Ii

    il y a 2 semaines

    Bruxelles, Région de Bruxelles, Belgique Thermo Fisher Scientific Temps plein

    CRA II / Sr CRA - BelgiumAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking...

  • Teacher in Chemistry-Integrated Sciences-ICT

    il y a 2 semaines

    Bruxelles, Région de Bruxelles, Belgique ECOLE EUROPEENNE DE BRUXELLES II Temps plein

    Teacher in Chemistry-Integrated Sciences-ICT (Lithuanian section) Position: 1 teacher Weekly Hours: 22 periods Contract Type: Replacement contract The European Schools provide a diverse educational environment with a focus on multilingualism and multiculturalism. We are searching for a qualified individual to teach chemistry-integrated sciences-ICT to...