Office Location: 225 Bush Street 16th Floor, San Francisco, California 94104.
Resverlogix is seeking a hands-on Clinical Operations professional responsible for the successful execution of Phase 1 and 2 clinical trials. The candidate should be familiar with the full range of clinical operations, from preparation of the protocol, through completion of the clinical study report and/or publication, and managing CROs to ensure completion of study deliverables.
Responsibilities:
• Participate in preparation of clinical trial documents such as the CRF, ICF and protocol, study report and review of regulatory submissions.
• Plan and conduct trial related meetings (operational team meetings, investigator meetings), identify and resolve clinical project issues and participate in process improvement initiatives as required.
• Conduct clinical site monitoring and audits, including resolution of audit findings. Prepare and review reports related to clinical operations, including but not limited to pre-study activities, site initiation visits, monitoring and close out visits. There will be extensive involvement with clinical studies conducted at international sites.
• Coordinate and participate in analysis of the clinical data.
• Develop and manage study budget and maintain within the financial goals, including review and approval of invoices against the approved budget.
Qualifications:
• Has strong knowledge of GCP, ICH guidelines and regulatory requirements for PHASE I-IV clinical trial management and strong clinical study management skills.
• Excellent communication, and organizational skills, along with problem solving, conflict resolution, leadership and team building skills.
• Minimum of 5-10 years of clinical experience in pharmaceutical, biotech or CRO company.
• Minimum of 3 years of trial management experience including managing CROs with a proven track record for delivering clinical trials within time, budget and quality expectations.
• Knowledge and experience in managing cardiovascular trial(s) is a plus.
• Bachelor’s degree or equivalent combination of education/experience in science or health-related field required.
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