Clinical Trial Manager

September 15

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Discovery of HLA-restricted tumor-associated peptides as cancer targets • Biomarkers • Immunomonitoring • Peptidomics & mass spectrometry • Standardized PBMC collection

201 - 500

Description

• Ensure clinical trial site management and monitoring activities in compliance with GCP guidelines. • Collaborate with COL to set targets for clinical monitoring activities. • Conduct and oversee the clinical trial site feasibility and site selection process. • Create, maintain and implement trial-specific plans, tools, and documents required per SOP. • Oversee or perform collection of clinical trial site specific documents ensuring on time regulatory submissions. • Driving the clinical site initiation and greenlight process according to project goals. • Actively contribute to clinical trial site management and engagement to establish and maintain close site relationships. • Organize and oversee project-specific training for CRAs and clinical trial sites. • Review trip reports and provide day-to-day expert advice to CRAs. • Review progress of clinical trials and initiates appropriate actions to achieve objectives. • Conduct Monitoring Oversight Visits ensuring clinical trial site and internal/external CRA performance. • Manage protocol and GCP deviations as Deviation Manager according to SOP. • Proactively contribute to continuous improvement of Clinical Operation specific processes.

Requirements

• Bachelor's degree, preferably in life science, nursing, or equivalent • At least 2 years of on-site monitoring and 2 years of CTM experience in the pharmaceutical or biotechnology industry (including all clinical monitoring visit types) • Comprehensive knowledge of ICH-GCP, FDA and EMA and applicable local regulations and laws • Understanding of basic medical oncology terminology and science preferable • Demonstrated computer skills, including Microsoft Office and clinical trial systems (i.e., eTMF, CTMS) • Advanced understanding of priorities within own scope with limited interaction with the supervisor • Proactively driving quality and efficiency to meet timelines and milestones in own scope • Advanced presentation and organizational skills