Global Clinical Trial Manager

Job Description: • Supporting in the global implementation of the sponsor studies from the receipt of the protocol concept to final CSR • Request and ensure delivery of Pharmacovigilance database set-up, training slides, and SAE forms • Develop Master Informed Consent Form(s) and management of all template updates • Review and maintain updated Trial Master File (TMF) • Develop/Review Study Plans, Manuals and tools, as applicable • Manage Vendor specification development/review, Review of monitoring reports • Oversight of User Management Tool (UMT) and report review • Site visits, as required • Facilitate label development and translations • Answer site IP questions and coordinate with IRT Requirements: • Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience • At least (3) years of relevant experience as Global CTM • Clinical research organization (CRO) and ONCOLOGY therapeutic experience preferred • Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements • Strong organizational skills • Strong ability to manage time and work independently • Ability to embrace new technologies • Excellent communication, presentation, interpersonal skills, both written and spoken • Ability to travel as necessary (approximately 25%) Benefits: • Health benefits to include Medical, Dental and Vision • Company match 401k • Eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) and sick time Apply tot his job Apply To this Job