Clinical Research Project Manager – PST/EST/CST Timezone

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

📋 Description

• Take ownership of and oversee the study start-up process, from the initial study award or feasibility through to site activation and readiness for the enrollment of the first patient.

• Create comprehensive study start-up plans, including timelines, milestones, and deliverables.

• Collaborate with regulatory, contracts, budgets, clinical operations, finance, recruitment, technology, and other functional teams.

• Monitor feasibility, regulatory submissions, IRB approvals, contracts, budgets, training, system readiness, and sponsor requirements.

• Confirm that all study documentation, approvals, and operational requirements are completed prior to site activation.

• Identify critical-path activities, dependencies, delays, and develop mitigation plans.

• Act as the primary coordination point for internal departments, sponsors, CROs, vendors, and site leadership.

• Facilitate start-up meetings, delegate action-item responsibilities, and ensure follow-through.

• Raise risks, delays, and unresolved issues along with recommended solutions and recovery plans.

• Construct and maintain project plans, study start-up trackers, milestone reports, and centralized documentation.

• Organize operational readiness, including staffing, training, supplies, systems, and necessary documentation.

• Verify the readiness of CTMS, eRegulatory, eSource, EDC, and other study-specific systems.

• Ensure adherence to GCP, regulatory requirements, sponsor expectations, and organizational SOPs.

• Assist in the transition from study start-up to ongoing clinical research operations.

• Provide structured updates on study progress, milestones, risks, and forthcoming steps.

• Facilitate meetings with documented decisions, assigned owners, and due dates.

• Promote accountability, eliminate bottlenecks, and enhance study start-up workflows and activation cycle times.

⛳️ Requirements

• A Bachelor's degree in life sciences, healthcare administration, clinical research, or a related field; relevant equivalent experience may also be considered.

• A minimum of 3–5 years of experience in clinical research, ideally within clinical trial operations, site operations, or study start-up.

• Proven experience in managing clinical research projects, study start-up activities, or site activation processes.

• Strong comprehension of the clinical trial lifecycle, especially feasibility, regulatory requirements, IRB submissions, contracts, budgets, and site activation.

• Experience in coordinating multiple functional departments and managing interdependent deliverables.

• Extensive knowledge of Good Clinical Practice (GCP), clinical research regulations, and standard operating procedures.

• Proficient with project management tools, trackers, Microsoft Excel, and collaborative platforms.

• Outstanding written and verbal communication abilities.

• Proven capability to manage multiple studies or projects simultaneously while ensuring accuracy and meeting deadlines.

• Experience working within a clinical research site, site network, SMO, CRO, or sponsor organization.

• Direct experience managing multiple study activations at the same time.

• Familiarity with CTMS, eRegulatory, eSource, and EDC platforms such as CRIO, Clinical Conductor, RealTime, Florence, or similar systems.

• Experience in developing study start-up dashboards, standardized trackers, and operational performance reports.

• Proven track record of improving clinical research workflows and reducing study start-up cycle times.

• Ability to coordinate teams and stakeholders without direct reporting authority.

• Competence in managing competing priorities and adapting to changing timelines while maintaining high execution quality.

🏝️ Benefits

• Remote work arrangement

• Full-time employment

• Opportunity to support clinical research clients

• Professional and operational growth through involvement in clinical research projects

• Exposure to regulatory, technology, and project management support functions

• Practical, results-driven solutions and an environment focused on operational excellence