31.03.2023Fresenius KabiEysins (Schweiz)Director Clinical Operations (m/f/d)The Director Clinical Operations is responsible and accountable for planning, coordinating, overseeing and conducting complex global clinical trials in one or more therapeutic areas.
The Director Clinical Operations collaborates in a global environment, using best practices and knowledge of internal and external business issues to improve processes, standards, and services.
The Director Clinical Operations is accountable to plan, drive and monitor program related activities throughout the lifecycle of the project ensuring targets are met according to timelines, budget and quality expectations.
Lead (multiple) cross-functional teams and drives oversight of CRO's and vendor management and has in-depth business knowledge and strategic understanding of how cross-functional teams jointly achieve objectives and goals of trial team, utilizing knowledge of the organization, processes, customers and key business drivers to increase effectiveness.
Understand the different requirements of agencies related to the clinical packages and plans manages accordingly the different functions (ie CSR, TFLs, ISS etc.).
Accountable 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.
Prepare clinical program updates and/or contribution to them as needed.
Support Head Clinical Operations in establishing and monitoring best Clinical Operation Practices.
Support Head Clinical Operations with strategic planning for the new FKSBS assets.
Act as Line manager to Clinical Operations personnel.
Participe in relevant meetings.
Plan and set up cross-functional meetings, meetings with vendors and others as needed.
Own and/or contribute to SOP development / reviews.Advance degree in life sciences (graduate degree), e. g. Biology, Chemistry, Pharmaceuticals preferred or medical background.
At least 10 years' experience in clinical research in industry, and at least 5 years in clinical trial management.
Strong leadership experience in leading teams.
Management competencies (leadership, problem solving and decision making skills).
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.
Fully 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, PowerPoint.