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
• 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