Description:
The Clinical Operations Manager will be responsible for supporting the Director, Clinical Operations successfully lead all clinical operational aspects of phase I – IV global clinical trials. This role will support the execution of clinical operations strategy, the planning, initiation, and execution of 1 or more clinical trials, including vendor selection, contracts and budgets, vendor oversight and management. Proactive risk identification is required to ensure on-time delivery of quality trials that meet the highest level of compliance, related to global and/or local clinical trials from the study start-up to the clinical study research report.
Essential Functions:
+ Primary contact for CRO Clinical Trial Manager, Project Manager. Primary contact for CRO legal and Internal legal for Clinical Trial Agreement negotiation/ escalation and for Letter of Indemnification negotiation/escalation. Primary contact for CRO study start-up team for clinical site budget escalation. Receives and distributes project documents for internal Amneal review, such as ICFs, operation manuals, and study plans. Escalates questions from CRO to internal Amneal Team.
+ Under the direction of the Director, Clinical Operations, determine timelines, goals and objectives and ensure the successful execution of multiple clinical trial projects in different therapeutic areas in a timely manner.
+ Involved in the CRO selection process, including but not limited to the review of Request For Proposal documents, participation in Bid Defense Meetings and determining deliverables.
+ Lead the Study Team and contribute to the Study Concept development with regard to operational aspects; develop the comprehensive overview and operational plans for the study, including the creation of essential project documents, such as protocols, CRFs, ICFs, safety updates, and clinical study reports.
+ Review CRO invoices against statement of work and ensure accuracy. Review CRO trip reports and seek clarifications on monitoring issues
+ Reviews and approves site and vendor invoices, including investigator grants and pass through costs against statement of work and ensure accuracy.
Additional Responsibilities:
+ Provide internal support with the monitoring of clinical trial data and issues associated with the data.
+ Works closely with internal Regulatory and Compliance teams to provide clinical content input for IND Submission documents Sunshine Act Reporting and ClinicalTrial.gov sum-mary updates.
+ Involved in the review process of Clinical Operations study documents provided by the CRO.