Job Description
- 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
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