EastHORN Clinical Services is one of the leading clinical research organisations (CRO) in Europe. We operate in over 15 countries in the region with an experienced staff comprised largely of physicians and PhDs. We serve global pharmaceutical and biotechnology companies in the development of new medicines and modern medical technologies. The company has operations throughout Europe and since starting 12 years ago, we have expanded significantly.

Our international clients value our enthusiastic, flexible and quality-focused professional approach to meeting their needs, and we are continuing to grow further. To support our future development, we are currently looking for an experienced

Clinical Operations Manager, based in Cologne, Germany

Job summary:

As an experienced Line Manager of Clinical staff, you will be responsible for management and mentoring of assigned Clinical Operations staff and will oversee their quality of performance. You will play important role in operational resource management and have decisive and leadership function in the administrative management of the German office.
Reporting to the Chief Executive Officer, you will be an important member of the Clinical Operations team in the company.

Main Tasks include, but are not limited to:

  • Responsible for detailed performance review, identification of training needs and performance issues, and resolution of all issues for assigned Clinical Operations staff
  • Conducts Quality Control visits with Clinical Research Associates to identify and ensure good performance and quality of work
  • Identifies assigned operational staff’ training needs, organizes and / or performs trainings
  • Responsible for resource management and work allocation
  • Assists in the staff recruitment process
  • Supports Project Management staff to assure that quality and EastHORN and Sponsor timelines are achieved
  • Directs the development, implementation and adherence to relevant SOPs and project plans
  • Assists in Business Development activities, coordinates feasibility process
  • Acts as a “country representative” during client meeting / Bid defenses
  • Supports regulatory submission and site contract negotiation processes
  • May serve as a project liaison for Clinical Operations activities for assigned projects, as required
  • May act as Country Manager and administrative head in EastHORN’s smaller offices

Competencies:

  • Life science or medical educational background or experience
  • Minimum of 6 years’ experience within the pharmaceutical industry or related field with preferably minimum 3 years clinical monitoring experience and minimum 1 year’s experience of line management of clinical staff
  • Excellent knowledge of ICH-GCP guidelines, ability to lead a clinical project team, and to encourage team members to seek solutions
  • Thorough working knowledge of drug development process, in particular monitoring and site management skills
  • Experience in study start up activities
  • Demonstrated ability to coach and mentor other clinical staff
  • Excellent planning and organizational skills to handle multiple priorities
  • Experience in middle size CRO is an advantage
  • International line management experience is an advantage
  • Analytical, interpersonal, negotiation skills
  • Proactive and able to work with little or no supervision
  • Advanced computer competency
  • Excellent written and oral communication skills in German and English

Benefits:

  • Working with experienced and very professional and supportive team
  • Possibility to build and develop an excellent clinical operations team
  • Possibility to grow within the Company
  • Flexible approach to work time
  • Competitive remuneration
  • Eligibility to the Company Bonus scheme

If you are an enthusiastic and energetic personality and would like to contribute to the further success of a dynamic young company in a growing market, please send your CV and motivation letter to: careers@easthorn.eu or complete the form below:

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