Senior Director Clinical Operations (f/m) (office/home based – western EU) The Senior Director, Clinical Operations is responsible for the overall management of the Clinical Operations Department and its team members that support clinical trials in compliance with applicable regulations, ICH-GCP Guidelines and SOPs for the European region. S/he manages the planning and implementation of department and company wide activities and initiatives in a matrix environment. We are looking forward to you application!
Tasks and Responsibilities
- Responsible for the overall management and success of the Clinical Operations department including leadership, people development, budgeting, planning, and compliance.
- Management duties include oversight of Clinical and Administrative personnel including employment, motivation, training, counseling, profession development, discipline and performance evaluation. Effectively manages workload of supervised staff, with continual assessment and adjustment as necessary.
- Responsible for ensuring clinical project resources are continuously adequate; participates in the interview and selection of clinical personnel.
- Responsible for the management and reporting of Key Performance Indicators (KPIs). Responsible for implementing actions to achieve department targets.
- Responsible for the management of department utilization and evaluation and reporting of non-billable time. Responsible for implementing actions to achieve utilization department targets.
- Allocates resources with focus on efficiency, timelines and project deliverables.
- Develops, modifies and executes company policies that affect immediate operations and may also have company-wide effect. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
- Responsible for the development and revision of clinical SOPs and department guidelines to ensure adherence to applicable ethical, regulatory and clinical standards.
- Provides input to the Clinical Operations portion of proposals, budgets and contracts.
- Provides support to the daily conduct of ongoing communication responding to inquiries from clinical sites and project team members; addresses client requests, as applicable.
- Bachelor’s degree in a life science or related field of study or equivalent combination of studies, nursing qualifications, and/or work experience.
- 15+ year’s relevant experience, including a minimum of 10 years directly managing others effectively.
- Extensive depth of experience in clinical study management, monitoring, and in developing study-related documents.
- In-depth knowledge of ICH-GCP guidelines and applicable regulations.
- Intermediate proficiency in Microsoft Word, Excel, Outlook, Internet Explorer and Power Point.
- Effective verbal and writing skills; English + local languages
- This position requires the ability to travel a minimum of 30%.
What we have to offer
- An exciting and challenging position in an international environment
- Working with highly motivated local and international colleagues
- A position where you can make a difference
Have we sparked your interest? Then we are looking forward to receiving your application! Please apply online and state you earliest start date or notice period as well as your desired fixed salary for such a position: http://www.synteracthcr.com/Careers/Career-