Start-up associate ii (italy)

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8h3cal

PAt 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. /ppWe are looking for a Start-Up Associate II (SUA II) to join our A-team (hybrid*/remote) in Italy! The SUA 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 and acts as a main line of communication to RA/ IEC/ IRB as well as investigators and sites through the initial phase of a clinical study until the Site Initiation Visit. /ph3In this roleyour key tasks will include: /h3ulliTrack relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities (as defined below) /liliEnsure planned dates are reliable and up to date in CTMS departments/study teams /liliFile documents in the (e)TMF for which they are the document owner /liliAssist other Study Start-up team members with filing documents in the (e)TMF for which they are document owner /li /ululliAssist in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials at local level /liliProvide relevant documents in compliance with local regulation /liliSupport review of technical, pre-clinical and clinical reports for regulatory submissions /liliInteract with regulatory authorities /liliPrepare and compile answers for questions raised by the regulatory agencies and submit the answers /liliRegularly check for updates on regulations, guidelines and procedures. Ensure these updates are communicated and circulated as appropriate /liliSupport Global Regulatory Manager (GRM) and/or Global Submission Specialist (GSS) as needed /liliPrepare, compile,



submit and maintain ethical requirements and documentation required by IEC/IRB for clinical trials at local level /liliAssist in providing and reviewing relevant documents in compliance with ethical requirements and per local legislation /liliInteract with IEC/IRB /liliPrepare and compile answers for questions raised by the IEC/IRB and submit the answers /liliRegularly check for updates on regulations, guidelines, and procedures. Ensure these changes and updates are communicated and circulated as appropriate /liliAssist in adapting country SIS/ISF to site-specific requirements /liliProvide country specific requirements to GSCM impacting site contracts' process /liliPrepare, 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 /liliNegotiate within client approved contract and budget templates and negotiation parameters /liliCommunicate with sites and internal personnel regarding the status of contracts and contract related documents /liliArrange translation of the final country CTA template and/or final negotiated contracts, where applicable /liliProvide the final/draft CTA and site budget for submission, where required /liliObtain site signature as well as Sponsor/Allucent signature,



as applicable /liliKeep up to date with applicable local regulations impacting clinical trial contracts /liliAssist in preparing the site-specific Essential Document Package and sending to sites /liliResponsible for collection and first review of Essential Documents /liliProvide the Global Essential Document Reviewer with the collected documents for independent review /liliFollow up with the sites regarding all document discrepancies noted by the Global Essential Document Reviewer until resolution /liliObtain authorization for the shipment of Investigational Product to the site /liliTrack relevant information and data in CTMS and/or other tracking tools /li /ulh3To be successful you will possess: /h3ulliLife Science degree or equivalent qualification or certification in a related allied health profession from an appropriate accredited institution. /liliMore than 2 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry. /liliA thorough knowledge of the country or region competent authority submission and reporting requirements and guidelines. /liliA thorough understanding of the drug development process /liliGood oral and written communications skills - fluent in Italian and English. /liliAttention to detail. /liliAble to perform well as a team member. /li /ulh3Benefits of working at Allucent include: /h3ulliComprehensive benefits package per location /liliCompetitive salaries per location /liliDepartmental Study/Training Budget for furthering professional development /liliFlexible Working hours (within reason) /liliParticipation in our enriching Buddy Program as a new or existing employee /liliInternal growth opportunities and career progression /liliFinancially rewarding internal employee referral program /liliEligibility for our Spot Premio Award Program in recognition of going above and beyond on projects /liliEligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees /li /ulp*Our in-office 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. /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8h3cal