Project Director, Evidence Development – Clinical Operations CRO

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide strategic direction, vision, and support to project teams, ensuring alignment with the objectives of the company and expectations of clients.

• Enhance project management performance, ensure quality delivery, adhere to milestone timelines, optimize financial margins, and boost customer satisfaction through effective leadership.

• Guarantee that project teams develop project plans that adhere to contracted services and timelines.

• Engage in cross-functional interactions within UBC to address project requirements and facilitate problem resolution; involve Senior Management as needed.

• Participate in project internal and external meetings and audits as required.

• Lead and mentor multidisciplinary project teams, including Project Managers, Operations teams, vendors, and other functional staff, to ensure effective communication, collaboration, and performance of project deliverables in accordance with contract terms.

• Collaborate with cross-functional managers to ensure adequate staffing for projects and that team members receive appropriate training for their specific roles.

• Select, contract, and oversee external vendors and subcontractors as necessary while ensuring quality and cost-effectiveness.

• Monitor project delivery against scope and budgets, demonstrating strong oversight of the financial health of assigned projects.

• Manage project budgets, resource expenditures, and ensure compliance with forecasting, invoicing, revenue recognition, out-of-scope management, and contract modifications.

• Continuously identify project risks and develop strategies to mitigate their impact effectively.

• Serve as the primary operational contact with clients for all project-related matters, maintaining strong relationships, addressing their needs, and providing regular updates on project status.

• Implement quality control measures to uphold the highest standards of data integrity, patient safety, and protocol compliance.

• Prepare, maintain, and deliver high-quality project progress reports, metrics, and other outputs to clients and UBC senior management.

• Assist with specific business development opportunities as directed, including capabilities presentations, RFP reviews, proposals/budget input, and participation in bid defenses.

• Responsible for the development, implementation, and compliance of project management processes for global projects.

• Lead, innovate, and develop operational strategies that fulfill requirements and maximize the success of project delivery.

⛳️ Requirements

• Bachelor's degree in a relevant field (Life Sciences, Healthcare, or Business) or equivalent industry experience.

• An advanced degree (Master's or Ph.D.) is preferred.

• At least 12 to 15 years of clinical research operations experience within a CRO, pharmaceutical, device/diagnostics, or biotechnology company.

• A minimum of 10 years of experience with increasing levels of project management or clinical research oversight responsibilities.

• Prior experience as a Project Director or Director of Clinical Operations (related) within a CRO is preferred.

• At least 5 years of supervisory or management experience.

• Proven ability to lead, motivate, and manage cross-functional teams.

• Strong understanding and experience in operational clinical operations and the overall drug/biologic development processes.

• In-depth knowledge of functional components of clinical drug development (e.g., clinical, data management, statistics, and medical writing).

• Comprehensive understanding of ICH GCP and applicable international regulations (EU Clinical Trials Directives, FDA Guidelines, etc.).

• Broad therapeutic experience is a plus.

• Excellent understanding of and experience managing evidence development projects (e.g., Phase IV studies, RWE, Phase II-III clinical trials, expanded access programs, etc.) globally.

• Ability to drive operational strategy for global evidence development programs.

• Experience in proposal and budget development for evidence development programs.

• Client-focused with strong leadership capabilities.

• Excellent verbal, written, and interpersonal communication skills.

• Strong prioritization, time management, and project management skills.

• Proficient in negotiation, influencing, consensus building, and relationship management.

• Strong innovative, analytical, problem-solving, and decision-making abilities.

• Solid financial acumen and experience in budget management.

• Proficient in computer skills, including MS Office.

• Familiarity with project management tools and software.

• Results-driven and team-oriented, with the ability to influence outcomes as necessary.

• Demonstrated ability to manage staff to achieve company and client objectives.

• Capacity to handle multiple tasks in a fast-paced, deadline-oriented environment.

• Availability for 10% travel.

🏝️ Benefits

• Competitive salaries.

• Opportunities for career advancement.

• 401K with company matching.*

• Tuition reimbursement.

• Flexible working environment.

• Discretionary Paid Time Off (PTO).

• Paid Holidays.

• Employee assistance programs.

• Medical, Dental, and Vision coverage.

• Health Savings Account (HSA)/Flexible Spending Account (FSA).

• Telemedicine services (Virtual doctor appointments).

• Wellness program.

• Adoption assistance.

• Short-term disability coverage.

• Long-term disability coverage.

• Life insurance.

• Discount programs.