Clinical Study Manager

The Company: An innovative life sciences organization focused on the development and delivery of high quality clinical programs. The organization operates in a highly regulated environment with a strong emphasis on patient safety, data integrity, quality, and collaboration.

Role description: The Clinical Study Manager will lead cross functional clinical trial activities and coordinate the Clinical Management Team, including external CRO partners. The role is responsible for delivering assigned clinical trials within agreed timelines, budgets, quality standards, and regulatory requirements. It also provides oversight of trial risks, vendor activities, budgets, documentation, audits, and stakeholder coordination.

Responsibilities: Lead the cross functional trial specific Clinical Management Team and CRO partners; Deliver clinical trials within agreed budgets, timelines, and quality standards; Ensure trial activities comply with SOPs, applicable regulations, and ICH GCP; Coordinate internal and external stakeholders to support trial progress; Participate in CRO selection and scope of work definition; Manage CRO activities throughout assigned clinical trials; Escalate trial issues when necessary to protect progress and quality; Participate in audits and inspections and support timely responses; Maintain trial budgets and oversee forecasting, accruals, and invoice management; Lead risk management assessments relating to patient safety and data integrity; Coordinate clinical trial activities and maintain trial documentation.

Requirements: Bachelor's or Master's degree with a relevant specialization; Master's degree preferred; Minimum 5 years of clinical operations experience; Significant experience leading and managing clinical trials; Experience coordinating clinical trial activities; Experience maintaining clinical trial documentation; Strong CRO engagement and management experience; Experience with clinical trial budget monitoring; Knowledge of ICH GCP and applicable clinical trial regulations; Strong stakeholder coordination and collaboration skills; Experience supporting clinical audits and inspections; Strong risk management capabilities.

Other Information: If you are interested and want to apply, please submit your application via the apply button below and contact me.