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Job Details

Manager, Clinical Monitoring Services - Warsaw, Poland

Company: Premier Research
Location: Warsaw, Poland
Reference: 1073SR
Closing Date: 31 Aug 18
Type: Full Time
Salary (£): Competitive
Benefits: Comprehensive

Job Summary:

Premier Research helps highly innovative biopharmaceutical and medical device companies transform life-changing ideas into reality. We’re looking for a seasoned, talented and energetic Manager, Clinical Monitoring Services who will cover Clinical Operations and be General Manager for our Warsaw Office to join our team! This is an office based position.

Requirements:

Premier Research helps highly innovative biopharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research. 

We’re looking for a seasoned, talented and energetic Manager, Clinical Monitoring Services who will cover Clinical Operations and be General Manager for our Warsaw Office to join our team!  This will be an office based position.

The Manager, Clinical Monitoring Services responsibility in 5 areas: Customers, Providers, Regulators, Employees and Infrastructure.

You'll be accountable for:

  • Developing and executing local business strategy aligned with Company Global goals
  • Engaging with customers, staff, providers, and regulators to explore and develop leads/opportunities in the community
  • Addressing challenges in a prompt manner collaboratively and ethically
  • Ensuring continued learning and organizational improvement
  • Designing business strategies and interventions based on local industry needs and opportunities
  • Partnering with the Premier Management team to ensure the effective development and growth of the Company’s footprint and infrastructure, both tangibly and intangibly
  • Maintaining a positive work environment, caring for the wellbeing of the staff, their career growth and maintaining a high performance culture
  • Hosting all company activities in a fit-for-purpose environment, representing the Premier brand in positive and influential way
  • Acting as Premier Research liaison/representative with the local community and Universities
  • Ensuring Premier full understanding of local and regional Regulatory nuances.

In time, you may also be accountable for the direct line management and supervision of CTM monitoring staff including skills assessment, training, resourcing, performance evaluation and career development. This may include: 

  • Assisting in staffing activities such as recruiting, hiring, interviewing, proposal and budget development, monitoring resource assignments, and retention of high-quality monitoring staff
  • Optimizing efficiencies of CMS departmental processes, including performance management metrics and quality initiatives
  • For each direct report, maintaining retrospective and prospective vigilance of utilization, availability to take on additional work and employee satisfaction
  • Promoting a strong team approach to ensure project alignment through active collaboration and communication with project management 
  • Working with the CMS leadership to implement effective orientation, mentoring, and career development programs for CTM monitoring staff
  • Assisting in reinforcing therapeutic and project-specific training as requested by project management
  • Managing individuals at remote sites and ensures they have proper equipment and setup to function effectively from a remote location
  • Performing co-monitoring field assessment visits periodically to assess GCP/ICH knowledge and compliance in practice and to ensure continued level of optimal performance. Supplementing assessments by proactively seeking input from appropriate project managers as to project-specific performance
  • Contributing to the CMS strategy through participation in special assignments, process improvement assessments, CRA training, etc.
  • Performing additional duties and assignments as requested
  • Must be available to perform overnight travel, as required

You will need this to be considered:
 

  • An undergraduate degree (or equivalent) in biological sciences or related field, or RN (or equivalent) with clinically relevant experience is required; advanced degree is preferred 
  • Previous demonstrated experience gained in the pharmaceutical or related industry in a clinical research capacity, some of which should be field monitoring experience as a clinical research associate (CRA, SCRA or the equivalent)
  • Prior line management and mentoring supervisory experience is required preferably in a matrix management structure; project management and budgetary responsibility experience preferred 
  • In-depth understanding of the importance of industry best practices, clinical performance and productivity toward implementation of study plans and study progress
  • Demonstrated knowledge of FDA/ICH guidelines and GCPs
  • Special knowledge of clinical monitoring operations/functions, application of regulatory compliance guidelines, CRO operations and medical terminology
  • Proven effective management and leadership skills
  • Ability to motivate, nurture and mentor staff
  • Excellent communication skills (verbal, written and interpersonal)
  • Attention to detail and strong organizational and time management skills
  • Strong interpersonal and customer service orientation for internal and external associates to proactively identify and resolve issues
  • Ability to handle and prioritize multiple assignments in a fast-paced environment
  • Ability to work independently as well as part of a project team
  • A flair for developing and maintaing long lasting business relationships with current and previous clients, providers, regulators.
  • Experience at proposing new and profitable business opportunities in both operational and business areas, to include consulting prospects
  • Proven experience of attending bid defences

Applications must be eligible to work in the hiring country.

Apply for this job: Manager, Clinical Monitoring Services - Warsaw, Poland

Contact Information:

Address:  European Headquarters
1st Floor,
Rubra 2
Mulberry Business Park,
Wokingham,
RG41 2GY
England
View our Profile Page
Tel:  +44 (0) 118 936 4000
Fax:  +44 (0) 118 936 4001
Website:  Visit Our Web Site

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