14 ago - Italia
Altro
The Position: As a key member of the Country Study Start‐Up Team, you will drive and accelerate efficient, compliant clinical trial initiation. You will lead country‐level strategies, cross‐functional collaboration, and process innovations to ensure seamless trial delivery for patients, investigators, and global study teams. Si candidi (facendo clic sul pulsante apposito) dopo aver controllato tutte le informazioni di lavoro riportate di seguito. Responsibilities Lead country study start‐up strategies, mitigate risks, and ensure timely site activation in alignment with global goals. Oversee clinical trial submissions and amendments; manage regulatory queries and maintain compliance (ICH‐GCP, EU CTR). Manage site documentation, local vendor coordination, and translation/approval of patient‐facing materials. Oversee site budgets (FMV‐based), negotiate contracts (CDAs, indemnity/insurance), and maintain accurate forecasting data. Identify process automation opportunities, harmonize systems with global counterparts,
and engage with external bodies (Ethics Boards, Health Authorities). Qualifications Education: Degree in Life Sciences or equivalent. Postgraduate degree or master's degree highly desirable. Experience: Proven track record (3‐4 years) in clinical trial start‐up, regulatory submissions, and CRO/vendor management. Regulations: Strong knowledge of ICH‐GCP, EU CTR, IVDR/MDR, and local regulatory environments. Core Skills Proficiency in clinical systems (Veeva Vault, CTIS, RIM, etc.). Strong communication, analytical, and problem‐solving skills. Ability to lead through ambiguity within global, matrixed teams. Fluency in Italian and English (written and spoken) is mandatory. Location & Compensation Location: Monza. Contract type: Fixed‐Term. Salary range: €30,986 – €57,540. Roche Italy offers a 14‐month period salary. xrdztoy Roche is an Equal Opportunity Employer. #J-18808-Ljbffr
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