Manager, Start Up - Remote

Study Start Up Spain


Description

Position at Premier Research

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for an exceptional Manager, Study Start Up to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world. This position can be in Italy, France, United Kingdom, Spain, Romania and Bulgaria.

 At Premier Research, we are science-minded and heart-centered. Join us.

The Manager, Start Up is responsible for the direct line management of Site Start Up Staff; Regulatory Start Up Managers and/or Site Start Up Associates, including training, resourcing, performance evaluation and career development. In addition, the Manager, Start Up has oversight of site initiation, site essential documents during the life cycle of a trial, execution and completion of study deliverables according to contractual agreement.

Your main responsibilities:

  • Manages staffing and resources to ensure departmental utilization
  • Drives study start up teams to meet project timelines
  • Assists in determining efficiencies for study start up to continually improve and streamline current processes without compromising quality 
  • Performs all aspects of managing/mentoring direct reports for  HR items, training and performance management 
  • Manages and motivates direct reports with project and people management responsibilities 
  • Prioritizes multiple assignments in a fast-paced work environment
  • Maintains spreadsheets regarding metrics and provides monthly updates to upper management or as needed
  • Maintains working knowledge of costing for tasks involved with Study Start Up and sourcing staff
  • Manages resourcing and staffing of new studies awarded to Premier Research to ensure that studies are adequately staffed and timelines are met
  • Prepares forecasts for staff utilization over the life of the study
  • Ensures appropriate transition planning and stakeholder communication for any staff changes
  • Provides Time Entry Guidelines to the clinical staff and applicable training
  • Identifies out-of-scope tasks from the clinical team and ensures pre-approval of these tasks
  • Completes performance evaluation for direct reports for annual appraisals
  • Reviews and advises on Regulatory and Clinical Operations SOPs, WGs and ADs related to study start-up ·
  • Mentors staff, as applicable, and works closely with staff for career pathing to ensure growth in the company as desired ·
  • Participates in corporate initiatives and actions that ensure the continued success of the company ·
  • Acts as a resource for other Managers and seek opportunities to share knowledge base · Recognizes strategic opportunities to improve department productivity  ·
  • Develops training and implementation for own staff, as well as other departments
  • Produces succinct documentation and presentation for both internal and external use with minimal input from upper management 

You’ll need this to be considered:

  • Undergraduate degree or its international equivalent in clinical, science, or a health-related field from and accredited institution; a licensed health-care professional (i.e. registered nurse); or equivalent work experience required
  • Minimum of 5 years of clinical research industry required
  • 1+ years people management experience
  • Analytic skill set to review metrics and feasibility numbers
  • CRO, Device and/or Pharmaceutical experience preferred
  • Working knowledge of FDA, European Regulatory and EC procedures as applicable
  • Ability to handle multiple task to meet deadlines in a dynamic and changing environment is essential.
  • Working knowledge of ICH / GCP regulations
  • Strong knowledge of web-based communication tools for conferences and any other IT systems required for the job
  • Knowledge of national/local health systems as well as knowledge of cultural/professional practices appropriate to the country/region where the site start up activities  will be carried out
  • Knowledge of the principals of project management
  • Fluent verbal and written English 
  • Excellent team player, collaborative and able to build an effective team
  • Good verbal and written communication and negotiation skills
  • Good organizational and time-management skills, able to prioritize work to meet deadlines
  • Customer service focused in approach to work, both internally and externally
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