| OXiGENE - Career Opportunities |
|
|
Home
> Who We Are > Career Opportunities
Job Description - Clinical Trial Manager
Description:The Trial Manager will oversee work assignment and deliverables for Contract Research Organizations (CROs), independently contracted managers and/or other specified resources. The Trial Manager is responsible for management of investigative site activities through the oversight of contracted activities, including prestudy site evaluations; site initiations, interim monitoring and site close out activities. The Trial Manager is responsible for meeting overall clinical operational timelines from study start-up activities to completion of the clinical study report.
Responsibilities:
Provide clinical monitoring input for clinical program plans, protocols and timelines for assigned projects.
Manage all site-related study start up activities, including investigator recruitment and selection, collection of regulatory documents, IRB/EC submissions, negotiation of Clinical Trial Agreements and Investigator Grants, Investigator Meetings and/or Site Initiations.
Coordinate and create necessary materials for clinical trial training for investigative site personnel and CRAs as necessary.
Confirm investigative sites' adherence to pertinent regulations with regards to protection of subject's rights and safety through review of monitoring reports, QA-GCP audits and communications with CRO CRAs, CRO Project Managers (if applicable) and/or investigative site personnel.
Oversee the collection of and validate all study and site-specific regulatory documentation necessary for initial drug shipment and filing to the IND and NDA.
Assign, manage and track the completion, quality and timeliness of tasks and deliverables for CROs.
Perform evaluations of CRO performance via co-monitoring visits, and document in co-monitoring visit reports.
Plan, track and conduct follow-up on all site GCP audits, and vendor audits as required.
Coordinate and generate necessar |
|
|
| Show job |
|
|
|
