QSSR-CMO-CLINICAL OPERATIONS MANAGER
QSSR-CMO-CLINICAL OPERATIONS MANAGER
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
- Responsible for trial management to ensure all aspects of trials are executed as planned
- Manage and oversee all activities of contract research organization (CRO)
- Participate in review of contracts (CROs sites etc.)
- Manage clinical site preparation and validation activities
- Establish and maintain the Trial Master File (TMF) including essential and nonessential documents. Ensure current copies of lab certificates regulatory approvals research personnel credentials etc. are updated in a timely manner and are in compliance.
- Establish relationship with CRO and/or study site personnel to keep track of patient enrollment and treatment schedules. Ensure patient followups for clinical results are received in timely manner.
- Ensure the conduct of the study is in compliance with the currently approved protocol/amendment(s) with current GCP guidelines and with applicable regulatory requirements.
- Maintain investigational product accountability and traceability Ensure product shipped necessary to meet study requirements and usage for each enrolling patient per clinical site.
- Manage and support the clinical trial support team
- Manage clinical trial progress and ensure completeness of documentation and data collection in adherence with the project
timelines. - Verifications of clinical activities and review of invoices according to the budget
- Reporting status of the trial to senior management.
- Perform other duties as assigned to ensure successful management and completion of clinical trial.
Requirements
Minimum 3 years experience in managing operational activities of clinical trials is required.
Previous experience running global trials is an asset.
Must have a good working knowledge of medical terminology and an excellent knowledge of applicable U.S. and international investigational regulations and guidelines.
Excellent oral and written communication organizational and planning skills.
Detailoriented a selfstarter and be comfortable with broad responsibilities in an entrepreneurial fastpaced small rapidly growing company environment.
Maintains proper communications with other departments to ensure communication and good relationships in connection with matters related to clinical trial projects
Direct experience in managing a clinical trial support team CRO is an asset.
Employment Type
Full Time
