Position Reports to:
Vice President, Clinical Operations
As the overall clinical trial manager, build and maintain relationships with Clinical Coordinators, Investigators, CRAs and CRO team members. Interact frequently with site staff and CRA management and communicate regularly with senior management. Based on a thorough understanding of the mechanics of conducting clinical trials, closely supervise all study-related activities from study start-up through study close-out and clinical study report writing.
- Directly oversee contract CRAs, the CRO study team(s), clinical sites and vendor(s) on assigned studies to ensure consistency of methods, interpretation and approach with other Syndax sponsored studies.
- Manage the process to prepare all clinical documents; write elements of protocols, clinical study reports, informed consents, study training materials / presentations, and other clinical documents, as needed.
- Conduct both operational and study content training for CRAs and CRO study teams (and study site staff, as needed); ensure all team members are appropriately trained throughout the course of the study.
- Oversee monitoring activities and conduct clinical site initiation visits, co-monitoring and close-out, as needed; review site visit reports and critical correspondence.
- Manage study timeline and provide study progress reports to the study team. Provide options for handling problems that develop.
- Oversee to ensure that paper and electronic filing systems are maintained appropriately and in a timely manner.
- Maintain tracking for study metrics essential to managing the study closely (patient visit information, data entry, monitoring and cleaning information).
- Ensure all tasks that contribute to the conduct of a clinical study are completed according to GCPc and SOPs, as well as on time and within budget.
(Skills, Knowledge, Education and Work Experience)
- Bachelors’ Degree in life sciences or healthcare discipline; Master’s Degree preferred.
- At least 7 years of clinical trial management experience, including at least 2 years of clinical monitoring in biotech/pharmaceutical industry; some Oncology trial experience is preferred;
- Skilled in supervising people;
- Working knowledge of GCPc and FDA and ICH regulations and guidelines;
- Experience with international clinical trials and managing external service providers, including CROs and contract CRAs;
- Good understanding of cross-functional areas including data management / biostatistics, regulatory affairs and pharmacovigilance;
- Proven verbal and written communication skills; enjoys interacting with others regularly;
- Able to prioritize tasks, solve problems and work with a high degree of independence;
- Able to travel up to 10% as needed, both domestically and internationally.