Remotery

Clinical Project Manager, Clinical Adjudication

Posted 2 days ago

This is a fully remote position, open to applicants in Costa Rica.

📋 Description

• Develop and implement project plans, incorporating timelines, milestones, and resource needs that align with study goals.

• Analyze study protocols and response assessment criteria; collaborate with stakeholders to create study initiation documentation and activities.

• Set up project reporting timelines and deliver timely updates to leadership, sponsors, and internal teams.

• Ensure effective communication with project teams, study sites, and sponsor representatives to promote alignment and transparency.

• Recognize critical success factors and oversee project tracking, analysis, and reporting.

• Coordinate cross-functional resources and collaborate with departmental leaders to guarantee appropriate training and excellence in delivery.

• Oversee financial components of projects, including forecasting, billing, scope modifications, and pass-through expenses.

• Maintain a comprehensive understanding of project contracts and assist with revenue reporting needs.

• Ensure compliance with SOPs; work with Quality Assurance on clarifications, deviations, and documentation.

• Lead and nurture project teams, establishing clear expectations and fostering consistency in performance and quality outcomes.

• Offer coaching and feedback on team member performance in collaboration with functional managers.

• Assist Business Development efforts, including capability presentations and involvement in client and investigator meetings.

• Supervise project closeout activities, encompassing submission coordination and final deliverables.

• Fulfill supervisory responsibilities as needed, such as hiring assistance, performance management, and team development.

• Promote continuous improvement by reviewing and contributing to updates in SOPs and departmental standards.


⛳️ Requirements

• Bachelor’s degree or equivalent experience in life sciences, pharmacy, nursing, or a related healthcare domain.

• Demonstrated project management experience in clinical development or investigational medications.

• 1–3 years of experience in clinical trials within a CRO or pharmaceutical research organization, preferably in a project management role.

• Working knowledge of GCP/ICH guidelines and FDA regulations.

• Experience in clinical adjudication is highly preferred.

• Proficiency in tools such as Microsoft Word, Excel, Access, and Project.

• Excellent interpersonal, communication, and stakeholder management abilities.

• Proven organizational, leadership, and problem-solving skills.

• Ability to juggle multiple priorities while maintaining professionalism in a fast-paced environment.

• Strong commitment to quality, accuracy, and continuous improvement.


🏝️ Benefits

• Competitive compensation.

• Private health insurance.

• Engaging employee programs.

• Flexible work schedules.

• Attractive PTO plan.

• Flex workspace.

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