About The Position

OBJECTIVES/PURPOSE Oversee and provide quality patient engagement and recruitment services that allow study teams to meet patient enrollment goals. Work to deploy new processes, methodologies, data and technologies for future implementation ACCOUNTABILITIES Oversee execution of patient recruitment deliverables regarding operational planning activities supporting clinical project teams building phase 2 through phase 4 clinical research studies including: Early operational planning, Protocol synopsis feasibility assessments, Enrollment forecasting and modeling, building Recruitment support strategies (e.g. central recruitment), Recruitment and retention plans Ensure delivery of high-quality subject recruitment and retention plans in collaboration with the Takeda clinical project teams/study team and contracted supplier(s) before First Patient First Visit. Manage quantitative decision support framework for strategy development, vendor selection, and objective setting. Manage contract and vendor relationship framework to align with adherence to RVRM and quantitative decision support framework. Systematically evaluate and communicate financial impact of specialist vendor (recruitment and retention) and recruitment strategies to important partners. Build daily delivery of activities as described above supporting clinical programs (e.g. including delivery of decision support data and methodologies for protocol development, site selection and management of recruitment support vendors. Support Director with activities related to: process improvement and mapping, training, inter-departmental collaboration (e.g. compliance, DSI technologies)

Requirements

  • Bachelor's Degree.
  • 5 or more years of experience in patient recruitment with evidence of increasing responsibility within a pharmaceutical company, CRO or similar organization.
  • Expertise in developing recruitment and retention strategies, country/site identification, and generation of material and trial metrics.
  • Successful leadership, and development of large, diverse globally dispersed teams experience.
  • Knowledge of leading-edge trial optimization vendors, tools, and methods.
  • Knowledge of current regulatory requirements and guidelines governing clinical research.
  • Experience in process design and improvement.
  • Understanding of clinical trials, relevant knowledge of GCP/ICH and applicable global regulations with regard to trial optimization strategies.

Responsibilities

  • Oversee execution of patient recruitment deliverables regarding operational planning activities supporting clinical project teams building phase 2 through phase 4 clinical research studies including: Early operational planning, Protocol synopsis feasibility assessments, Enrollment forecasting and modeling, building Recruitment support strategies (e.g. central recruitment), Recruitment and retention plans
  • Ensure delivery of high-quality subject recruitment and retention plans in collaboration with the Takeda clinical project teams/study team and contracted supplier(s) before First Patient First Visit.
  • Manage quantitative decision support framework for strategy development, vendor selection, and objective setting.
  • Manage contract and vendor relationship framework to align with adherence to RVRM and quantitative decision support framework.
  • Systematically evaluate and communicate financial impact of specialist vendor (recruitment and retention) and recruitment strategies to important partners.
  • Build daily delivery of activities as described above supporting clinical programs (e.g. including delivery of decision support data and methodologies for protocol development, site selection and management of recruitment support vendors.
  • Support Director with activities related to: process improvement and mapping, training, inter-departmental collaboration (e.g. compliance, DSI technologies)

Benefits

  • U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.
  • U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
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