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CALL FOR CONSULTATION   +1.724.272.1245

 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
  • Management 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. 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, please email
 your specific interest, your current CV/resume, and hourly rate to Alethea Wieland,   alethea@clinicalresearchstrategies.com.

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Trust

Compliance

Transparency

Authenticity


Purpose