Director, Clinical Study Management – Project Management

This is a fully remote position, open to applicants in Romania, +2 more countries.

📋 Description

• Provide leadership and oversight for global activities and timelines concerning the execution of full-service clinical trials.

• Supervise project management and project finance teams.

• Engage in the development and execution of organizational strategies, technologies, and best practices.

• Ensure exceptional customer service, staff development, quality information management reporting, and effective divisional objectives.

• Create and enhance policies and processes.

• Oversee product quality and compliance monitoring.

• Plan staff resources and manage the performance of staff and contractors.

• Represent project and finance teams with sponsors and clients throughout the project lifecycle.

• Guarantee high-quality, timely service in alignment with corporate and industry best practices as well as regulatory requirements.

• Support Business Development through the creation of bids and bid defenses.

• Take part in operational planning and translate strategic plans into measurable goals and targets.

• Oversee project development, resource and financial planning, trial conduct, confidentiality, and issue resolution.

• Ensure adequate project-level staffing and maintain utilization targets.

• Represent project operations in cross-departmental planning initiatives, client meetings, business development meetings, bid defenses, scientific conferences, and investigator meetings.

• Mentor and support managers and leaders in work allocation, resource planning, training, development, engagement, team building, and performance management.

• Assess and implement recommendations to reduce organizational risk and adhere to regulatory or industry standards.

• Plan, manage, advocate for, and report on departmental budgets and annual operational reviews.

• Manage financial and regulatory risks and requirements.

• Prepare budgets and proposal documents for RFPs, RFIs, and statements of work.

• Oversee change orders for full-service projects to ensure alignment between realized project costs and the work performed.

⛳️ Requirements

• An undergraduate university degree (Bachelor or Honors Bachelor) along with a minimum of 10 years of related experience and ongoing training/development OR a college diploma/degree and at least 15 years of related experience.

• Extensive experience in the CRO industry with a focus on full-service project management leadership.

• Proven experience in coaching and leading a team with a commitment to excellence.

• Phase II experience is a prerequisite.

• Phase III experience is highly preferred.

• Experience in managing gastrointestinal (GI) clinical trial projects is highly desirable.

• Significant financial accountability, encompassing substantial involvement in budget setting, autonomous expenditure, and/or revenue generation decisions in accordance with company policy or financial processing, reconciliation, and reporting.

• Resumes must be submitted in English.

🏝️ Benefits

• Education Reimbursement program for full-time employees.

• Monthly Cell Phone and Remote Work Allowance (dependent on role eligibility).

• One-time office setup allowance for equipment, office furniture, and related items.

• Working while visiting program – up to 4 weeks per year.

• Flexible Summer Hours Program from May – September.

• Employee referral incentive.

• Full-time employees become beneficiaries of the Alimentiv Trust after one year of employment and permanent members after 5 years of employment.

• Optional formal mentorship program (Alimentorship).

• Country/region annual social events in person.

• Leadership development programs for people leaders based on seniority.

• Social committee and other optional initiatives.

• Additional benefits may be available depending on the country of employment and local policies and eligibility.

• Equal opportunity employer.

• Accommodations available upon request for persons with disabilities.