Director, Clinical Study Management (Project Management)

Alimentiv

About The Position

Alimentiv is hiring a global Director, Clinical Study Management to provide leadership and oversight for the global activities and timelines involved in executing full-service clinical trials, including project management and project finance teams. As a member of the senior leadership team, the Director contributes to organizational strategy and its implementation, including strategies, technologies, and best practices that support customer service, staff development, quality information management and reporting, and effective divisional goals aligned with the organization’s vision and mission. The role includes policy and process development and improvement, product quality, compliance monitoring, staff resource planning, and staff and contractor performance management. The Director represents project and finance teams with sponsors and clients throughout the project life cycle and supports Business Development with bid development and defense as needed. The role oversees operational planning and project delivery, translating strategic direction into measurable short- and long-term goals. It involves working with sponsors and functional directors on project development, resource and financial planning, trial conduct, confidentiality, and troubleshooting; ensuring staffing and utilization targets; and representing project operations in cross-department initiatives. The Director also leads and develops the Clinical Project Operations team, supports managers and team members with work allocation, training, engagement, performance management, and team development, and represents the function at client and business development meetings and investigator meetings as needed. The Director collaborates with organizational leadership to improve service excellence, reduce risk, and meet regulatory and industry standards. The position also supports departmental budget planning and review, monitors financial and regulatory risks, contributes to proposals and budgets, and oversees change orders for full-service projects to ensure project costs are realized in line with work performed. The position is global; candidates should inquire with Talent Acquisition about eligible countries of residence outside the locations where the role is advertised.

Requirements

Undergraduate university degree (Bachelor or Honors Bachelor) and at least 10 years of related experience and training/continuous ongoing development, or a college diploma/degree and at least 15 years of related experience.
Deep experience in the CRO industry with full-service project management leadership.
Experience coaching and leading a team with an excellence mindset.
Phase II clinical trial experience is a prerequisite.
Significant financial responsibility, including extensive participation in budget setting, autonomous expenditure and/or revenue-generation decisions subject to company policy or financial processing, reconciliation, and reporting.

Nice To Haves

Phase III clinical trial experience.
Experience in gastrointestinal (GI) clinical trial project management.

Responsibilities

Provide leadership and oversight for global activities and timelines related to full-service clinical trial execution, including project management and project finance teams.
Contribute to organizational strategies and implement technologies and best practices supporting customer service, staff development, reporting, and divisional goals.
Develop and improve policies and processes; oversee product quality, compliance monitoring, resource planning, and staff and contractor performance management.
Represent project and finance teams with sponsors and clients throughout the project life cycle.
Ensure teams provide high-quality, timely service in accordance with corporate and industry best practices and regulatory requirements.
Support Business Development through bid development and defense.
Participate in operational planning and translate strategic plans into measurable short- and long-term departmental goals and targets.
Work with sponsors and functional directors on project development, negotiating and delivering quality products while assessing resource, financial, and safety requirements.
Assign resources, oversee trial conduct and information and data confidentiality, and support project teams in troubleshooting and resolution.
Ensure sufficient project-level staffing and maintain utilization targets.
Represent project operations in cross-department planning initiatives.
Provide leadership, mentorship, and support to managers and team members in work allocation, resource and staff allocation, training and development, employee engagement, team development, and performance management.
Represent project operations at client meetings and business development meetings, including bid defenses, capability presentations, and scientific conferences; attend and present at investigator meetings as needed.
Collaborate with the leadership team to improve project service excellence, minimize organizational risk, and meet regulatory and industry standards.
Plan, manage, advocate for, and report on behalf of the department during budget and annual operational review processes.
Monitor financial and regulatory risks and requirements related to service delivery and direct the development of methods to review and manage them.
Work with Business Development to prepare budgets and proposal text for requests for proposals, requests for information, and statements of work.
Oversee change-order development for full-service projects and ensure project costs are realized in line with work performed.

Benefits

Education reimbursement program for full-time employees.
Monthly cell phone and remote work allowance, depending on role eligibility.
One-time office setup allowance for items such as a scanner/printer, extra monitor, or office furniture.
Working while visiting program of up to four weeks per year.
Flexible Summer Hours Program from May through September.
Employee referral incentive.
Eligible full-time employees become beneficiaries of the Alimentiv Trust after one year of employment and permanent members after five years.
Optional formal mentorship program.
Country/region annual in-person social events.
Leadership development programs for people leaders, in accordance with seniority.
Social committee and other optional initiatives.
Additional benefits may be available depending on country of employment and local policies and eligibility.
Annual bonus target.