Director, Clinical Study Management (Project Management)

3 hours, 50 minutes ago
Full-time
Executive
Project and Program Management
Alimentiv

Alimentiv

Alimentiv specializes in providing comprehensive clinical research services for gastrointestinal and liver diseases, leveraging a global site network, advanced medical imaging, and biomarker discovery to enhance patient recruitment and accelerate clini...

Professional Services
501-1000
Founded 1986

Description

  • Develop and execute short- and long-term operational plans for the Clinical Project Operations function.
  • Oversee the delivery of full-service clinical trials, including project development, resource allocation, trial conduct, confidentiality, and issue resolution.
  • Lead, mentor, and manage Clinical Project Operations leaders and staff, including staffing, work allocation, training, engagement, and performance management.
  • Maintain adequate project staffing and utilization targets across the function.
  • Represent project operations in sponsor, client, investigator, cross-functional planning, business development, and scientific conference meetings.
  • Establish and improve policies, processes, quality standards, and compliance monitoring practices in line with regulatory and industry requirements.
  • Drive project-service excellence initiatives to reduce organizational risk and support company growth.
  • Lead departmental budget planning, operational reviews, financial reporting, and financial-risk management.
  • Partner with Business Development to prepare proposals, budgets, bid defenses, and statements of work.
  • Oversee change-order development to ensure project costs are recovered in line with work performed.

Requirements

  • Bachelor’s or Honors Bachelor’s degree plus at least 10 years of related experience and ongoing professional development, or a college diploma/degree plus at least 15 years of related experience.
  • Deep CRO industry experience in full-service clinical project management leadership.
  • Experience coaching and leading teams with a focus on operational excellence.
  • Phase II clinical trial experience is required.
  • Phase III clinical trial experience is highly desirable.
  • Gastrointestinal clinical trial project management experience is highly desirable.
  • Significant financial resource-management experience, including budget setting, expenditure or revenue decisions, reconciliation, and reporting.
  • Knowledge of financial and regulatory risks and requirements related to clinical trial service delivery.

Benefits

  • Education reimbursement for full-time employees.
  • Monthly cell phone and remote-work allowance, based on role eligibility.
  • One-time home-office setup allowance.
  • Work-from-another-location program for up to four weeks per year.
  • Flexible summer hours from May through September.
  • Employee referral incentive program.
  • Eligibility for the Alimentiv Trust after one year, with permanent membership after five years.
  • Optional mentorship, leadership development, social events, and employee engagement programs.

Interested in this position?

Apply directly on the company website

Apply Now

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