Note: The job is a remote job and is open to candidates in USA. Syntagma Group is seeking a Senior Clinical Project Manager who will be responsible for all aspects of clinical study management, providing performance metrics, and overseeing CRO and other vendors. This role involves leading functional team members to ensure the quality of deliverables and successful delivery of clinical studies in collaboration with the Director of Clinical Operations.
Responsibilities
- Oversees site study activities, quality, timelines and the study budget with internal functional leads, CRO and vendors to ensure that the overall project objectives are met
- Oversee and participate in study start-up and ensure all startup activities, including site selection and activations are aligned with internal timelines
- Partner with the CRO to ensure participant enrollment targets are met
- Work with CRO to ensure site and data monitoring strategies are developed and carried out effectively
- Initiate and build professional relationships both with clinical site staff and CRO and vendor partners
- Take part in the development of and management of clinical study documents including, but not limited to, Protocols and amendments, Informed Consent Forms (ICFs), confidentiality agreements, translated clinical documents
- Responsible for helping to develop, track, review, and manage study related plans and processes, including but not limited to Investigator agreements (CTA), clinical monitoring plan (CMP), safety monitoring plan (SMP), lab manuals, protocol deviations, etc
- Responsible for overseeing the clinical study budget and Investigator site grants
- Oversee monitoring activities, ensure compliance with the CMP, perform site monitoring and co-monitoring visits as needed; review of monitoring visit reports
- Closely oversee CRO and study vendors, as applicable, to ensure compliance with ICH/GCP requirements and internal SOPs, where applicable
Skills
- 7+ years of experience in the pharmaceutical/biotechnology industry which includes experience as a Clinical Study Lead for a multi-region/multi-site study with a successful proven track record
- Solid understanding of clinical development process from IND to NDA/BLA submission
- Proficiency in the areas of clinical site selection, initiation and management
- Bachelor's degree or equivalent in health-related field preferred
- Experience in working in a small organization is preferred
- Experience with Phase 1 and Phase 2 studies, rare disease and global clinical trials is a plus
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