Clinical Trial Manager (Advanced Clinical)

Clinical Research Universe Featured Jobs

Posted: June 13, 2017

Job ID: 171

Job Summary

Term: Contract
Job Roles: Trial/Study Management
Therapeutic Experience: Oncology
Required Education: BA/BS in related field
Required Experience: 4+ years

Job Description

Home based support for liquid tumor studies/programs.
- in-house study management experience is required as is Oncology experience
- experience managing all the moving parts of a trial or multiple trials

• Manage project timelines and vendor performance to meet departmental and corporate goals
• Manage study budget and payment process for all clinical trial vendors including investigative sites
• Monitor and track clinical trial progress and provide status update reports
• Manage all clinical trial vendors (e.g., IVRS, central labs, and IRB)
• Responsible for selection of CRO study staff and coordinating training including documentation
• Hire, train and oversee study Field Monitors (e.g., review of all trip reports) and provide guidance on site issues
• Lead with minimal supervision in the planning of investigator meetings and making presentations, as required
• Lead the review of clinical data at the CRF, data listing, and report table levels
• Represent Clinical Operations at the Project Team level for individual studies, as appropriate
• Partner with other research and development groups to achieve deliverables
• Participate in Site Initiation Visits (SIVs) as required
• Co-Monitoring of regional sites for adherence to protocol and GCP as required
• Travel as required to carry out responsibilities
• Identify and escalate site, vendor and study related issues to supervisor, as appropriate
• Participate in clinical and department settings, including attending additional meetings as required, and interact in a positive and professional manner
• Manage Clinical Trial Assistants and Clinical Research Associates, and perform performance appraisals Perform other duties as assigned
• Ability to work within a team, including leadership skills
• Ability to organize and prioritize multiple tasks
• Excellent communication and interpersonal skills
• Attention to detail, organization, and problem-solving skills
• Computer literate
• Knowledge of FDA regulatory requirements and medical practice/techniques and terminology
• 25% travel required
Experience and Education Requirements:
• BA/BS in related field
• Minimum 8 years clinical drug development experience
• Experience in personnel management
• Experience in managing oncology clinical trials (international preferred)

- should be comfortable traveling to the Bay Area for occasional team meetings

To apply:
Mohammad Ouranos| Senior Clinical Recruiter
P 858-732-9110