The Clinical Manager will be responsible for leading study operational strategy and planning and overseeing the execution of clinical studies for the organization.
Duties and responsibilities
Oversee the execution of studies in compliance with quality standards (including ICH GCP, local regulations and SOPs), on schedule and on budget.
Oversee CROs and other 3rd party vendors to meet obligations described in ICH-GCP and business objectives including CRO/vendor selection, budget and contract negotiation, and proper supervision of performance for all activities assigned to a CRO/vendor for assigned studies, including escalation of issues to governance committees when warranted.
Provide oversight/support/guidance to CRO to ensure study issues are addressed and resolved promptly.
Challenges study team to ensure operational feasibility, inclusive of patient and site burden, and timelines meet the needs of the clinical development plan.
Accountable for planning and operational strategy and execution for planned clinical trials.
Provides subject matter expertise and operational input into protocol synopsis, final protocol and other study related documents.
Ensure new team members and vendors are appropriately onboarded.
Responsible for study budget planning and management and accountable for external spend related to study execution. Ensures impacts to budget are adequately addressed.
Works closely with project team to ensure on a regular basis that budgets, enrollment, and gaiting are accurate; communicates study status, cost and issues to Program Lead(s); serves as escalation point for third party vendors managed by CROs.
Review of outcomes/actions related to protocol deviations review to support the identification of trends across sites and/or the study.
Documented review and monitoring of issues, risks and decisions at the study level and implementation of appropriate mitigation strategies.
In partnership with data management, review and pressure test all database timelines and plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation, etc.) with the tactical plan for database lock and clinical study reports.
Ensure studies are “inspection ready” at all times; may be involved in regulatory inspections by preparing for and/or attending the inspections.
Review and provide expert clinical operations input into clinical documents related to the drug/biologic/medical device development process including Investigator Brochures, Investigational New Drug or Device Exemption Applications (INDs & IDEs), clinical study reports, applicable sections of the Biologic License Application (BLA) and/or Pre-Market Approval Application (PMA), and updates to these documents.
Provide expert clinical operations input into preparation for key regulatory meetings (e.g. End-of-Phase 2 and 3 Meetings, Request for Scientific Advice Meetings, etc.), as appropriate
Other duties as assigned.
Bachelor’s degree or international equivalent required. Life Sciences preferred. Master’s degree in a relevant discipline preferred. Five or more years’ experience in pharmaceutical industry and/or clinical research organization, including 3+ years clinical study management. Experience must include either Phase 2 and 3 studies. Experience in more than one therapeutic area is advantageous. Excellent communication, teamwork, organizational, interpersonal, and problem-solving skills.
Telecommuting is allowed.
Internal Number: 06112020
About Vivex Biologics
We are constantly striving for creative treatment options and solutions to progress clinical, surgical, and therapeutic patient care by expanding industry knowledge and capability. Under the guidance of experienced and successful business professionals, we assemble the brightest minds from medical and material science industries to explore new and different ways to help others.
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