Senior Project Manager - Clinical Trials

The Senior Project Manager is responsible for leading complex, strategic, and cross-functional projects from initiation through successful implementation, ensuring full adherence to OCASA Life Sciences Project Management standards, methodologies, and governance processes.

This role will play a critical part in managing strategic customer-facing initiatives involving new services, operational implementations, clinical trial logistics programs, process improvement initiatives, digital transformation projects, and operational expansions.

The ideal candidate must possess substantial experience within the Clinical Trials, CRO, Pharmaceutical, Biotechnology, or Life Sciences industry. This experience is a mandatory requirement and is essential to effectively manage customer projects and navigate the unique operational, regulatory, and stakeholder challenges associated with clinical research and clinical trial supply chains.

The Senior Project Manager will serve as a trusted partner to customers, vendors, and internal stakeholders, ensuring projects are delivered on time, within scope, within budget, and in compliance with quality and regulatory expectations.

Key Responsibilities

Project Governance & Delivery

• Lead complex internal and customer-facing projects from initiation through successful completion.

• Define project objectives, scope, deliverables, timelines, budgets, and resource requirements.

• Develop and maintain project plans, schedules, budgets, risk registers, and governance documentation.

• Monitor project progress, milestones, dependencies, and critical paths.

• Identify risks and implement mitigation and contingency plans.

• Manage project changes through established governance and change control processes.

• Ensure project deliverables meet quality standards and stakeholder expectations.

• Provide regular project status reporting to senior leadership and customers.

Stakeholder & Customer Management

• Serve as the primary point of contact for project stakeholders, including customers, vendors, and internal teams.

• Facilitate communication and alignment across cross-functional teams and leadership groups.

• Lead project meetings, steering committees, workshops, and governance reviews.

• Manage customer expectations and ensure alignment with project objectives.

• Support customer onboarding, implementation, and operational transition activities.

Process Excellence & Continuous Improvement

• Lead End-to-End (E2E) process mapping, analysis, and optimization initiatives.

• Develop and maintain RACI matrices to establish accountability and ownership.

• Drive operational efficiencies through process redesign and continuous improvement methodologies.

• Apply Agile, Waterfall, Lean, Six Sigma, DMAIC, and other project management methodologies as appropriate.

Strategic Initiatives

• Lead large-scale projects including:

  • New customer implementations

  • New service launches

  • Clinical trial logistics programs

  • System implementations and integrations

  • Digital transformation initiatives

  • New operational start-ups and facility launches

  • Geographic expansion projects

• Manage external vendors and third-party partners throughout the project lifecycle.

• Support RFI, RFP, RFQ, and vendor selection processes when applicable.

Qualifications & Experience

Required

• Bachelor's Degree in Engineering, Supply Chain, Business Administration, Life Sciences, Information Technology, or related field.

• Minimum of 5 years of project management experience leading complex projects with multiple stakeholders and cross-functional dependencies.

• PMP, PRINCE2, Scrum Master, Agile Certification, or equivalent Project Management certification required.

• Proven experience managing customer-facing projects within the Clinical Trials, CRO, Pharmaceutical, Biotechnology, or Life Sciences industry.

• Clinical Trials industry experience is REQUIRED and NON-NEGOTIABLE.

• Experience managing large-scale operational, process improvement, technology implementation, or transformation projects.

• Demonstrated success leading End-to-End (E2E) process analysis and improvement initiatives.

• Strong customer-facing experience with executive-level stakeholders.

• Experience managing external vendors and third-party service providers.

• Strong written and verbal communication skills.

• Exceptional organizational and project management skills.

Preferred

• Experience in clinical trial logistics, depot operations, or clinical supply chain management.

• Experience supporting global clinical trial operations.

• Knowledge of GxP, GDP, ICH, or other regulated Life Sciences environments.

• Logistics and supply chain experience.

• Experience managing multi-country or global projects.

Language Requirements

• English: Fluent / Professional proficiency required (written and verbal).

• Spanish: Preferred but not required.

Location

This position may be based in either:

• Miami, Florida

• Raleigh, North Carolina

Candidates must be willing to work closely with global teams, customers, and stakeholders across multiple regions and time zones.