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Clinical Research Strategies delivers a wide variety of strategic and practical business solutions to life science entrepreneurs, investors and company executives.

Our Consultant | Project Manager and Consultant | Project Management Director roles are multi-dimensional requiring versatility, flexibility, critical thinking, and motivation to meet our client's expectations and contracted requirements. Minimal requirements of at least a bachelor's degree with 5 years in a regulated, clinical research or life science environment is necessary to achieve our desired results and to drive successful outcomes for our EU, North American and Asia-Pacific clients. Director-level roles are uniquely autonomous with a minimum of 10 years of progressive advancement in life science organizations and/or CROs, and will have direct accountability and responsibility to our clients requiring little to no supervision. Other dimensions of these roles include:

  • Oncology, precision medicine, and regenerative medicine experience preferred
  • NIH, NCI, and DoD grant experience
  • Exceptional time management and client communication skills
  • Adherence to US laws and regulations, business ethics, corporate and financial compliance, confidentiality, and industry-wide best practices
  • Facilitation of contracts, milestone invoicing, and payments
  • Production of SOPs, RFPs, gap analyses, TMF audits, written policies, regulatory positions, presentations, training programs, and white papers
  • Contributions to strategy for IND- and IDE-enabling drug and device products, submissions, and clinical trials
  • Preparation of fair market budgets (FMV) and realistic forecasts with disciplined spend
  • Application of GxP regulations and requirements to projects
  • Quality-driven management and oversight of vendors and CROs
  • Perform research for and participate in capability presentations of technology provider innovations that reduce costs to clients
  • Participate in conferences on AI, blockchain, interoperability and emerging technology for healthcare and life science industry
  • Follow FDA, EU, China, ICH-GCP, and ISO regulation changes
  • Creation of electronic files and maintenance of documentation in a regulatory-compliant and cyber-secure environment
  • Interface with regulatory officials, investors, business partners, and executives
  • Maintenance of client relationship management (CRM) system
  • Spearhead projects to completion
  • Creation of routine status reports for clients
  • Proficiency in software applications such as Outlook, Word, Excel, Visio, PowerPoint, Project, SharePoint, etc.

Clinical Research Strategies is an equal opportunity employer and has zero tolerance for workplace discrimination, bullying, or retaliation. Roles are consulting with an opportunity to become full-time or part-time positions. Clinical Research Strategies offers flexibility that enables professionals to work a range of hours each week under mutual agreement. To schedule a meeting to discuss your qualifications and open roles, email your current CV/resume, and rate to: