Clinical Trial Manager
Kyn Therapeutics, an emerging leader in cancer immuno-metabolism, is seeking a Clinical Trial Manager (CTM) to join an innovative, scientifically minded and fast paced team focused on developing breakthrough cancer therapies. The CTM will have excellent organizational skills and proven effectiveness in a fast-paced, small company environment.
The CTM will be responsible for the management of clinical trial activities on one or more of our lead programs. The CTM will support the clinical team with the implementation and conduct of clinical trials, focusing on the areas of trial planning, enrollment, site monitoring, data quality, and study reporting.
- Reports to Director of Clinical Operations
- Manages clinical studies according to applicable regulatory requirements
- Manages and oversees CRO/Vendors to ensure compliance with processes and regulatory guidelines
- Maintains a competent knowledge of applicable Policies, Guidelines, Standard Operating Procedures (SOPs), including current Good Clinical Practice (GCP) and applicable local regulations relating to the conduct of clinical trials.
- Participates in site identification, evaluation, contracting, initiation, monitoring and close out visits
- Communicates with clinical site staff, investigators and CROs as appropriate to ensure optimal Sponsor-site relationships
- In conjunction with the CRO and study team, monitors the timely progress of clinical studies
- Supports the management of site-related activities, development of tracking tools, and ability to manage recruitment timelines
- Prepares updates on study progress
- Participates in the selection and contracting of third-party vendors
- Manages the study budget, and tracks payment of contracts related to the project
- Accountable for accuracy and timeliness of trial information in all trial databases and tracking systems
- Anticipates potential study issues and prepare contingency plans with minimal oversight
- Facilitates Clinical Trial Agreements through Legal
- Reviews and approves all study documents such as monitoring reports, essential regulatory packages, ICFs, etc. for accuracy and quality content
- Drives traceability procedures for investigational products and coordinates clinical supply planning with CMC
- Develops study specific documents such as pharmacy manual and informed consent forms
- Trains CRO team members and site staff, as needed
- Responsible for day-to-day management of vendors working on assigned study, including setting expectations, training, managing timelines and deliverables, and issue management
- A minimum of 2 year’s experience managing multicenter clinical studies
- Requires a BS degree or equivalent in a health science field preferred
- Strong communication, negotiation and interpersonal/team skills
- Excellent computer skills (Microsoft Office Word, Excel, PowerPoint, Outlook) required
- Sound working knowledge of knowledge of the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines and other applicable regulatory guidelines required
- Familiar with Electronic Data Capture Systems
- Established ability to prioritize and manage multiple tasks simultaneously, demonstrate ability to identify and resolve issues, and effectively manage timelines
- Strong initiative and a can-do attitude, excellent people skills, and a proven record as a team player
- Flexible, mature and able to work under pressure
- Some travel will be required (10-20%)
This is an inhouse position.