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Job Details

Director Clinical Operations / Head of Clinical Operations Germany (f/m)

Company: SynteractHCR Deutschland GmbH
Location: Munich, Germany
Reference: 26928
Closing Date: 03 Dec 16
Type: Full Time
Salary (£): On Application
Benefits: Excellent

Job Summary:

Director Clinical Operations / Head of Clinical Operations Germany (f/m) Munich   The Director Clinical Operations will be 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 Germany as a Clinical Operations Country Head. S/he manages the planning and implementation of department and company wide activities and initiatives in a...

Requirements:

Director Clinical Operations / Head of Clinical Operations Germany (f/m)

Munich

 

The Director Clinical Operations will be 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 Germany as a Clinical Operations Country Head. S/he manages the planning and implementation of department and company wide activities and initiatives in a matrix environment.

 

Your Tasks and responsibilities

  • Responsibility for the overall management and success of the German Clinical Operations department including leadership, people development, budgeting, planning, compliance and resourcing
  • Representation of the Clinical Operations department for Germany in internal European and global meetings and in client meetings
  • Management duties include oversight of clinical and administrative personnel, including employment, motivation, training, counseling, professional development and discipline and performance evaluation
  • Responsibility for ensuring clinical project resources are continuously adequate; participates in the interview and selection of clinical personnel
  • Responsibility for the management and reporting of Key Performance Indicators (KPIs). Responsible for implementing actions to achieve department targets
  • Responsibility for the management of department utilization and evaluation and reporting of non-billable time. Responsible for implementing actions to achieve utilization department targets
  • 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
  • Responsibility 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, P&L topics and contracts for the German market
  • Provides support to the daily conduct of ongoing communication responding to inquiries from clinical sites and project team members; addresses client requests, as applicable
  • Responsibility for reaching the German project targets and for the quality of the deliverables from the Clinical Operations Team Germany

Your profile

  • Academic degree in a life science or related field of study or equivalent combination of studies, nursing qualifications, and/or work experience
  • 12+ year’s relevant experience, including a minimum of 6 years managing direct reports
  • Extensive depth of experience in clinical study management, monitoring and in developing study-related documents. Experience in Audit and FDA/EMEA inspections would be nice to have
  • In-depth knowledge of ICH-GCP guidelines and applicable regulations, especially for the German market
  • Proficiency in Microsoft Word, Excel, Outlook, Internet Explorer and Power Point
  • Effective verbal and writing skills; English + German

To apply

Have we sparked your interest? Then we are looking forward to receiving your application! Please apply through our homepage synteracthcr.com and state your earliest start date/notice period and your desired salary. If you have any questions regarding the position please contact antonia.schultze@synteracthcr.com

 

 

 


Apply for this job: Director Clinical Operations / Head of Clinical Operations Germany (f/m)

Contact Information:

Address:  SynteractHCR Deutschland GmbH
Albrechtstrabe 14
80636 Munich
Germany
Tel:  +49 89 12 66 80 0
Fax:  +49 89 12 66 80 2444
Website:  Visit Our Web Site

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