
Project Management Specialist
4 days ago
We are seeking a highly motivated and experienced professional to lead our clinical trials program. The successful candidate will have a strong background in clinical research, including management of all stages of interventional drug trials from study start up through data lock and study close out.
About the Position:- This is a key leadership role within the organization.
- The successful candidate will be responsible for overseeing all aspects of the clinical research protocol, including clinical and neuropsychological assessments; training and supervision of staff; participates in clinical visits; ensures that clinical databases are kept up to date.
- Manage study related documents including new Institutional Review Board protocols and continuing reviews, Investigational New Drug applications, and other regulatory documents.
- Interpret and apply GCP and IRB policies to support research compliance.
- Coordinate training program for, and oversight of, clinical coordinators/staff and manage assessment of competency for lab members.
- Establish standards for the delivery of research procedures; act as a role model by providing excellent service to internal and external contacts.
- Develop, evaluate and standardize operating procedures (SOPs) and effectively troubleshoots and resolves issues.
- Supervise day to day operations of all study staff. Responsible for training and supervision of new staff.
- Liaising with laboratory personnel.
- 5+ years of related clinical trials experience strongly preferred
- Minimum of 2-3 years of clinical research experience, including management of all stages of interventional drug trials from study start up though data lock and study close out.
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