The Clinical Trial Manager III will develop and manage clinical research operations for various therapeutics project(s) including timelines, budgets, personnel resources, investigational sites, vendors and key project deliverables. No patient contact in this position.
The Clinical Trial Manager III will:
- Facilitate completion of clinical trial protocol and Informed Consent Form (ICF)
- Coordinate study site selection and start up activities including contract and budget for individual investigation sites
- Request for proposals from contract research organizations (CROs) to outsource the clinical operations
- Evaluate the proposals and recommend CRO selection to senior management
- Review and approve clinical operation documents including case report form (CRF), CRF completion guidance, source document monitoring plan, data validation manual, statistical analysis plan, etc.
- Function as the main sponsor contact for various vendors
- Regularly update sponsor regarding trial progress, possible risks to timelines, issues arising during trials
- Manage CRO, review CRA monitoring reports, and track deliverable timelines
- Update the ICF and maintain ongoing IRB notification, review and approval.
- Review on-going clinical data as well as clinical study reports
- Facilitate study close out visits and ensure regulatory documents are archived properly
There will be supervisory responsibilities of external vendors and of FTEs as needed
- Tracking invoices and reconciling invoices with budget and /or contracts
· Excellent oral and written communication skills
· Ability to work well-independently
· Proficient in using Microsoft Project or equivalent tools to track project progress
· Understanding of FDA, ICH, and GCP guidelines as well of cross-functional clinical processes including data management, biostatistics, drug safety, and regulatory affairs
· Understanding of the design, conduct, analysis and interpretation of clinical studies.
· Basic knowledge of the drug development process.
- Masters of Science with at least 3 years of project management
- Experience with Contract Research Organizations an asset
- No laboratory work involved
- Up to 15% traveling time
Massachusetts General Hospital - 2 years ago