Senior Manager, Clinical Operations

Role Overview

• Responsible and accountable for planning, coordinating, overseeing, and conducting complex global clinical trials in one or more therapeutic areas.
• Collaborate in a global environment, using best practices and knowledge of internal and external business issues to improve processes, standards, and services.
• Accountable to plan, drive and monitor protocol related activities throughout the lifecycle of the project ensuring targets are met according to timelines, budget and quality expectations.
• Lead cross-functional teams and drive oversight of CRO’s and vendor management.
• Understand the different requirements of agencies related to the clinical packages and plans manages accordingly the different functions (i.e. CSR, TFLs, ISS etc.)
• Responsible for inspection readiness.
• Accountable for CAPAS related to clinical programs within the field of Clinical Operations.
• Accountable and responsible for the financial planning, budget, accruals, forecasts contribution.
• Preparing clinical program updates and/or contribution to them as needed.

Requirements

• Advance degree in life sciences (graduate degree), e.g. Biology, Chemistry, Pharmaceuticals preferred or medical background
• At least 7 years’ experience in clinical research in industry, and at least 5 years in clinical trial management
• Understanding GxP and global requirements
• Strong project management skillsets
• Excellent communication skills and ability to manage cross functional teams
• Ability to deal with complex situations and drive solution orientated thinking
• Fluent in English
• Excellent team player, ability to work under high pressure and pronounced resiliency
• Experience working in an international and cross-functional team
• Ability to present and defend the perspective
• Experienced in Microsoft project, Excel, Power point

Benefits

• Health insurance
• Professional development