Manages clinical study start-up teams, staffing, resources, timelines, metrics, and process improvements across multiple countries. Oversees direct reports through mentoring, training, performance management, and career development. Supports feasibility, costing, proposals, client presentations, SOPs, regulatory compliance, and study transitions. Establishes harmonized start-up processes while coordinating stakeholders and ensuring adherence to ICH/GCP, FDA, European regulatory, and applicable ethics committee requirements.
Premier Research is looking for a Manager, Start Up to join our Clinical Monitoring, Site Management and SSU team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
What you'll be doing:
- 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
- Assists in determining efficiencies for essential document maintenance to continually improve and streamline current processes without compromising quality
- Assists in proactively moving the department forward through involvement of corporate initiatives
- Performs additional duties and assignments as requested
- 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
- Creates and evaluates performance objective for direct reports
- Maintains spreadsheets regarding metrics and provides monthly updates to upper management or as needed
- Applies analytic skills to reports and feasibility in the Study Planning stage
- Maintains working knowledge of costing for tasks involved with Study Start Up and sourcing staff
- Recommends measures to reduce costs for Premier Research, when appropriate
- Contributes to aspects of business development, including evaluating and defining proposal specifications
- Presents to clients as needed or required
- Utilizes technology in search capabilities for Study Planning
- Ensures department staff is current on company SOPs as well as updates to industry regulations and guidelines
- Meets with staff regularly to ensure that studies are on target to meet timelines
- Works in a global environment and coordinates multiple countries
- 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
- Establishes harmonized process for study start up, maintenance and close out
What we're looking for:
- 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
- 2+ 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
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