29 ott - Roma
Allucent
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. /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 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 h3Requirements /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 /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 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 #J-18808-Ljbffr
29 ott - Stezzano
Nessun nome
29 ott - Bari
Società riconosciuta
29 ott - Bari
Società riconosciuta
29 ott - L'Aquila
Gruppo importante