Clinical Project Manager

Position Overview:

Provides project leadership in the initiation and execution of domestic and international clinical studies to support both product approvals and market adoption of company products.



Primary Responsibilities:



Write and develop clinical protocols, data and tracking forms, informed consent documents, operating procedures, and associated regulatory filings with investigational sites.

Assists in writing annual and final clinical study reports and clinical sections of regulatory filings.

Tracks data forms, reports, and documents necessary for completion of clinical study, both in-house and from participating study sites.

Works with team to establish study database and edit check requirements.

Serves as liaison between contracted research organizations, clinical trial sites, investigators, study coordinators, physicians, and staff members.

Conducts pre-study site qualification and initiation planning and execution including creation of training materials to ensure compliant study execution.

Assist study sites with IRB/EC submissions and annual reports.

Oversees delivery and shipment of products and equipment required to conduct clinical investigations.

Provides technical assistance to study sites regarding the conduct of clinical research.

Manages clinical sites to optimize the patient recruitment and screening process to reach study recruitment goals.

Perform co-monitoring visits with CRO staff at participating clinical sites

Assists as liaison with Data Management/Biostatistical groups to ensure resolution of data queries.

Monitors clinical and/or laboratory data to ensure accuracy, thoroughness, and regulatory compliance of clinical documentation.

Creates study Regulatory and Reference Binders as well as internal trial master file to track all study documents.

Review, reconcile and maintain Trial Master Files for multi-center, multi-national clinical trials