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Job Details

Clinical Operations Manager (CRA Line Manager) - Poland

Company: ClinTec International Ltd
Location: Poland
Reference: Pol-CRALM-230217-DH
Closing Date: 20 Apr 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

Clintec, a Global CRO, is actively recruiting for a Clinical Operations Manager to join our expanding global company in Poland. This is a permanent home or office based opportunity. By working for Clintec you can further your career in a dynamic, fast paced environment and you can be assured of rewarding benefits.

Requirements:

Clinical Operations Manager (CRA Line Manager) – Poland - Home or Office based in Krakow

Clintec, a Global CRO, is actively recruiting for a Clinical Operations Manager to join our expanding global company in Poland. This is a permanent home or office based opportunity. By working for Clintec you can further your career in a dynamic, fast paced environment and you can be assured of rewarding benefits.

Role Description:

The CRA manager is responsible for CRA’s in an allocated region and responsible for personnel management and ensuring projects are conducted in accordance with local and international regulatory requirements.

Responsibilities of the Clinical Operations Manager:

Resource Management

  • Work closely with PMs to identify resource needs in their region for each study,
  • In combination with the Head of Operations or Director of Monitoring, identify clinical operations staff who will be available to place on upcoming trials and if new hires are required work with GR, HR and PM to ensure suitable candidates are found
  • Coordinate CRA resource planning within region
  • Track and review current assignments for ClinOps staff (both Full service and allocated FSP Projects )
  • Maintain oversight of monitoring activities and ensure adherence to project goals, timelines and budget
  • Communicate regularly with Clin Ops staff to provide guidance and oversight of projects

 

Performance Management

  • Perform accompanied site visits
  • Oversee workloads to ensure Clin Ops staff are appropriately utilized
  • Participate in sponsor calls to check on CRA / sponsor interaction
  • Responsible for the development of CRA and creation of individual development plans
  • Conduct appraisals
  • Review competencies
  • Review performance against metrics on a monthly and quarterly basis
  • Institute CRA performance plans when necessary
  • Ensure local sponsor issues are handled and escalated appropriately
  • Provide oversight and initiative for ongoing GCP training

Recruitment  Activities

  • Work with HR to post new positions as necessary
  • Conduct interviews for potential new hires

Essential Criteria:

  • Bachelor’s Degree in Life Sciences, Medicine or Nursing or equivalent qualification / experience.
  • Knowledgeable about the drug development process, ICH-GCP and Local Regulatory Processes
  • Expert in clinical trial monitoring with recent practical hands on experience and the proven ability to coach, mentor and motivate others in this discipline.
  • Excellent communication skills including the ability to interact with clients and team members at all levels.
  • Good presentation skills in keeping with Clintec corporate image.
  • Ability to proactively identify issues and risks, and put in place mitigation and improvement measures where needed.
  • Empathetic individual with the ability to listen sensitively to employee or client issues and offer unprejudiced counsel, guidance and support where necessary.
  • Basic understanding of employment legislation or general people management.

Desirable Criteria

  • Previous experience as a Lead CRA or CRA Line Manager.
  • Management experience within Functional Service Provider business relationship.
  • High level of commercial awareness and ability to recognise ‘bigger picture’.

Company Information:

Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.

Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package. 

Apply for this job: Clinical Operations Manager (CRA Line Manager) - Poland

Contact Information:

Address:  Head Office
Clintec International Ltd,
133 Finnieston Street,
Glasgow
G3 8HB
Scotland
Reasons to work for Clintec
Tel:  +44 (0) 141 226 1120
Fax:  +44 (0) 141 248 8993
Website:  Visit Our Web Site

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