Job Title: CLINICAL PROJECT DIRECTOR (DIRECTOR, CLINICAL PROJECT MANAGEMENT) - RECENT CRO EXPERIENCE REQUIRED****
Job Description
The Project Director leads complex, global clinical research programs and large portfolios of oncology trials within a full-service CRO environment. This role serves as a key strategic partner to sponsors, providing high-level project leadership, financial oversight, and continuous process improvement to support organizational objectives in project execution. The Project Director often acts as a portfolio manager for a suite of studies, driving consistency, quality, and risk management across trials while mentoring project managers and contributing to departmental and company-wide initiatives.
Responsibilities
- Serve as the primary point of contact and liaison with clients, delivering outstanding customer service and representing the organization in proposal activities, client presentations, and bid defenses.
- Oversee and manage all aspects of clinical research trials or programs of trials, ensuring consistency, quality, and alignment across assigned portfolios.
- Provide direction and leadership to project managers, guiding project establishment, planning, initiation, procurement, execution, and closing activities.
- Manage study budgets, ensuring projects remain within scope, identifying out-of-scope activities early, and driving change orders to completion and execution with minimal support.
- Ensure functional areas fully understand and manage the study scope for their respective responsibilities.
- Oversee the financial health of assigned studies, including project profitability, billable project hours, and adherence to accurate, timely billing and forecasting to support business objectives.
- Develop or oversee the development of robust, comprehensive project plans, including detailed timelines and proactive risk management and mitigation strategies to guide trial execution.
- Implement strategic planning, risk management, and change management independently, ensuring these practices are embedded in project delivery.
- Ensure quality management for assigned projects, including eTMF inspection readiness and the implementation of quality notification incident forms and corrective and preventative action plans to address quality findings.
- Establish and maintain tracking metrics to monitor trial progress and team performance against project goals.
- Prepare and deliver project status updates for clients and sr management, including reporting on key performance indicators and presenting solutions and opportunities as they arise.
- Participate in sr management meetings as needed, providing insight and presentations on assigned studies and portfolio performance.
- Lead internal and client meetings, set clear expectations for the project team, and drive program- or study-level strategies forward.
- Oversee cross-functional project teams to ensure efficient management and execution of trials across all operational areas.
- Communicate effectively with sponsors and internal leadership to relay protocol and study issues, including deviations, and implement appropriate actions in response.
- Conduct formal presentations to a wide variety of audiences, including colleagues, investigative site staff, and clients, demonstrating a high level of proficiency in bid defenses and other strategic meetings.
- Ensure study-specific training is developed and implemented in collaboration with functional areas and monitor compliance with training requirements throughout the project lifecycle.
- Support business development and marketing activities as appropriate, including travel to and proactive preparation for bid defense meetings.
- Perform additional duties as assigned by leadership, contributing flexibly to organizational needs.
- Remain compliant with organizational training requirements, time reporting, and other administrative responsibilities.
- Mentor associate project managers, project managers, and sr project managers, supporting their professional development and growth.
- Participate in departmental updates, including the development and revision of company standard operating procedures (SOPs).
- Provide ongoing feedback to functional team members, including input into annual performance reviews.
- Identify performance issues at the project level and ensure appropriate operational corrective actions, such as training or process adjustments, are implemented.
- Travel domestically and internationally, including overnight stays, as required to support project and client needs.
Essential Skills
- Extensive full-service CRO project management experience, with direct responsibility for end-to-end trial delivery rather than FSP-only oversight.
- Strong oncology project management experience, with particular value placed on radiopharmaceuticals, CAR-T and cell therapy, and general oncology.
- Minimum of 8 years of clinical research experience or equivalent competencies relevant to this role.
- Minimum of 5 years of direct project management experience in clinical research, preferably within a CRO environment.
- Demonstrated leadership in managing highly complex and global studies or portfolios of studies.
- Strong client-facing presence with excellent presentation and communication skills, including experience leading bid defenses and formal client presentations.
- Proficiency in Microsoft Office products, including Outlook, Word, Excel, and PowerPoint.
- Experience using Microsoft Project for planning and tracking project timelines and resources.
- Proficiency with eTMF systems and clinical trial management systems (CTMS).
- Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative team setting.
- Strong organizational skills and attention to detail, with a consistent customer service mindset.
- Proven ability to provide leadership without direct reports, including mentorship, escalation handling, financial and budget oversight, and influence without formal authority.
Additional Skills & Qualifications
- Bachelors degree in a science or health-related field, or an equivalent combination of education and experience; candidates with strong oncology project management experience may be considered without a degree.
- Advanced degree in a relevant discipline is preferred.
- Experience serving as a portfolio manager for a suite of studies for significant clients.
- Ability to independently implement strategic planning, risk management, and change management within complex clinical programs.
- Experience preparing and presenting key performance indicators and project status updates to sr leadership.
- Capability to participate in and contribute to departmental initiatives, including SOP development and updates.
- Experience providing mentoring and performance feedback to project management and functional team members.
- Comfort with domestic and international travel, including overnight stays, to support client meetings, bid defenses, and study oversight.
- Understanding of CRO career progression structures (e.g., Project Manager, sr Project Manager, Project Director, Director of Project Management, Executive Director) and the ability to operate effectively at the Project Director level.
Work Environment
This role operates within a full-service clinical research organization environment focused on complex, global oncology trials. The Project Director collaborates closely with cross-functional teams, including clinical operations, data management, regulatory, and other specialized functions, using tools such as Microsoft Office, Microsoft Project, eTMF systems, and clinical trial management systems to manage day-to-day activities and long-term planning. The position involves regular interaction with external sponsors and internal sr leadership, including participation in strategic meetings, bid defenses, and portfolio reviews. Work is typically performed in a professional office or remote setting, with standard business hours and flexibility required to accommodate global time zones and critical project milestones. The role includes domestic and international travel, including overnight stays, to attend client meetings, bid defenses, and site or project-related visits. Career progression pathways commonly include Project Manager, sr Project Manager, Project Director, Director of Project Management, and Executive Director levels, offering opportunities for growth and increased responsibility over time.
Job Type & Location
This is a Permanent position based out of Raleigh, NC.
Pay and Benefits
The pay range for this position is $162000.00 - $243000.00/yr.
Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.
Comprehensive Medical, Dental & Vision Coverage - Generous employer contributions for employees and dependents, national Aetna plans, telehealth access, Delta Dental PPO options, and VSP vision coverage. 401(k) with Strong Employer Match - 4% employer match plus immediate 100% vesting through a Safe Harbor plan. Flexible Time Off - Exempt employees receive uncapped "My Time" (MTO), while non-exempt employees receive 20 days PTO annually, paid holidays, personal days, and volunteer time off. Family Planning & Parental Support - Infertility coverage, 8 weeks of paid maternity leave at 100% pay, 4 weeks of paid parental bonding leave, and up to $3,000 in adoption assistance per child. Company-Paid Life & Disability Insurance - Basic life insurance and AD&D up to 1.5x salary (maximum $500,000) plus short- and long-term disability coverage at 60% of pay. Health Savings Account (HSA) Contributions - Employees enrolled in the HDHP receive annual employer HSA contributions of $1,000 (individual) or $1,500 (family/employee-plus coverage). Wellness & Employee Assistance Programs - Free 24/7 support through Headspace, including mental health resources, counseling support, legal/financial assistance, work-life services, and access to over 3,000 wellness resources.
Job Type & Location
This is a Permanent position based out of Raleigh, NC.
Application Deadline
This position is anticipated to close on Nov 8, 2026.
Workplace Type
This is a fully remote position.
About Actalent
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