Clinical Site Manager

• Successfully implements and executes client s phase I III clinical trials at their assigned sites

• Ensures compliance with regulations, guidelines and policies for studies implemented at their assigned sites.

• Supports budget and contract negotiation with investigational sites, as applicable, at their assigned sites; ensures payment for services.

• Ensure recruitment strategies in place to meet study needs, including patient enrollment targets at their assigned sites.

• Collaborates with Clinical Study Teams and within GCSM to identify and resolve site, quality or study execution issues.

• Manage existing sites and develops new clinical investigator sites to meet client projected patient recruitment needs in their region. Works with Regional Manager to:

• Monitor site quality and performance (metrics); develop solutions to optimize performance.

• Monitor site availability, commitments, infrastructure and capabilities.

• Ensure all safety issue are communicated and managed by Principal Investigator and study team in timelines appropriate to the regulatory and protocol requirements.

• Develop and implements effective corrective action plans for all quality issues identified at assigned sites.

• Actively participates with study team to stay current with study needs, communicating as needed with sites within defined timelines.

• Train and qualify sites and Principal Investigators.

• Develop sites to optimally conduct studies.

• Maintain thorough knowledge of country regulations with special focus on regulatory requirements, guidance documents, and standards relating to global clinical trial conduct for medical devices, pharmaceuticals and biologics, and uses that knowledge to enhance site compliance and performance.

• Performs all monitoring activities according to protocol monitoring plan and relevant WIs

• Maintain / demonstrate knowledge of the protocol, General Monitoring Guidelines (GMG), Protocol

• Monitoring Plan (PMP) and all protocol specific requirements

• Executes and maintains compliance with all established client processes, procedures, and performance metrics.

• With support of Regional Manager, demonstrates flexibility to meet changes in work environment and study milestones with efficiency, and with strong communication and prioritization skills.

• Builds positive relationship with principal investigators and site personnel under his responsibility.

Skills:

Microsoft Office proficiency required - Outlook, Excel, Word

Electronic Data Capture (EDC) System Experience required Medidata RAVE preferred

Clinical Trial Management System Experience required - Medidata CTMS preferred

Travel required approximately 60%

Minimum of nine years related experience

Five years of direct regional field clinical monitoring / research.

Currently working in a regional position from an established home office is preferred.

Excellent verbal and written communication, problem solving skills and team orientation.

Education:Medical, pharmaceutical, biology, chemistry degree or RN preferred

For any of these locations below:

North Carolina

South Carolina

Georgia

Florida

Best Regards,

Anuj Mehta

973-967-3402