Start-Up Associate Ii (Italy)

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pAt AllucentTM, 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.
/p pWe 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.
/p h3In this roleyour key tasks will include: /h3 ul liTrack relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities (as defined below) /li liEnsure planned dates are reliable and up to date in CTMS departments/study teams /li liFile documents in the (e)TMF for which they are the document owner /li liAssist other Study Start-up team members with filing documents in the (e)TMF for which they are document owner /li /ul ul liAssist in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials at local level /li liProvide relevant documents in compliance with local regulation /li liSupport review of technical, pre-clinical and clinical reports for regulatory submissions /li liInteract with regulatory authorities /li liPrepare and compile answers for questions raised by the regulatory agencies and submit the answers /li liRegularly check for updates on regulations, guidelines and procedures.
Ensure these updates are communicated and circulated as appropriate /li liSupport Global Regulatory Manager (GRM) and/or Global Submission Specialist (GSS) as needed /li liPrepare, compile,



submit and maintain ethical requirements and documentation required by IEC/IRB for clinical trials at local level /li liAssist in providing and reviewing relevant documents in compliance with ethical requirements and per local legislation /li liInteract with IEC/IRB /li liPrepare and compile answers for questions raised by the IEC/IRB and submit the answers /li liRegularly check for updates on regulations, guidelines, and procedures.
Ensure these changes and updates are communicated and circulated as appropriate /li liAssist in adapting country SIS/ISF to site-specific requirements /li liProvide country specific requirements to GSCM impacting site contracts' process /li liPrepare, 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 /li liNegotiate within client approved contract and budget templates and negotiation parameters /li liCommunicate with sites and internal personnel regarding the status of contracts and contract related documents /li liArrange translation of the final country CTA template and/or final negotiated contracts, where applicable /li liProvide the final/draft CTA and site budget for submission, where required /li liObtain site signature as well as Sponsor/Allucent signature, as applicable /li liKeep up to date with applicable local regulations impacting clinical trial contracts /li liAssist in preparing the site-specific Essential Document Package and sending to sites /li liResponsible for collection and first review of Essential Documents /li liProvide the Global Essential Document Reviewer with the collected documents for independent review /li liFollow up with the sites regarding all document discrepancies noted by the Global Essential Document Reviewer until resolution /li liObtain authorization for the shipment of Investigational Product to the site /li liTrack relevant information and data in CTMS and/or other tracking tools /li /ul h3To be successful you will possess: /h3 ul liLife Science degree or equivalent qualification or certification in a related allied health profession from an appropriate accredited institution.
/li liMore than 2 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry.
/li liA thorough knowledge of the country or region competent authority submission and reporting requirements and guidelines.
/li liA thorough understanding of the drug development process /li liGood oral and written communications skills - fluent in Italian and English.
/li liAttention to detail.
/li liAble to perform well as a team member.
/li /ul h3Benefits of working at Allucent include: /h3 ul liComprehensive benefits package per location /li liCompetitive salaries per location /li liDepartmental Study/Training Budget for furthering professional development /li liFlexible Working hours (within reason) /li liParticipation in our enriching Buddy Program as a new or existing employee /li liInternal growth opportunities and career progression /li liFinancially rewarding internal employee referral program /li liEligibility for our Spot Premio Award Program in recognition of going above and beyond on projects /li liEligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees /li /ul h3Disclaimers: /h3 p*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 p"The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively "Allucent"). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources." /p #J-*****-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8a5asv