Clinical Research Project Manager – PST/EST/CST Timezone

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

📋 Description

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

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

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

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

• Ensure that all documentation, approvals, and operational prerequisites are fulfilled prior to site activation.

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

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

• Facilitate start-up meetings, designate action-item owners, and ensure accountability for follow-through.

• Raise awareness of risks, delays, and unresolved issues, providing recommended solutions and recovery plans.

• Develop and maintain project plans, start-up trackers, milestone records, and status reports.

• Coordinate operational readiness, which includes staffing, training, supplies, systems, and documentation.

• Validate the readiness of CTMS, eRegulatory, eSource, EDC, and other study systems.

• Ensure compliance with GCP, regulatory requirements, sponsor expectations, and organizational SOPs.

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

• Offer structured updates to stakeholders and lead meetings with documented decisions, owners, and due dates.

• Enhance workflows, handoffs, processes, and study activation cycle times.

• Promote timely study activation, adherence to milestones, risk resolution, project visibility, accountability, and continuous improvement.

⛳️ Requirements

• Bachelor's degree in life sciences, healthcare administration, clinical research, or a related discipline; equivalent relevant experience may be taken into account.

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

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

• In-depth understanding of the clinical trial lifecycle, including feasibility, regulatory requirements, IRB submissions, contracts, budgets, and site activation.

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

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

• Proficiency in project management tools, trackers, Microsoft Excel, and collaborative platforms.

• Outstanding written and verbal communication abilities.

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

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

• Preferred: Experience in managing multiple study activations at the same time.

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

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

• Preferred: PMP, ACRP, SOCRA, or other relevant professional certifications.

• Preferred: Experience in improving clinical research workflows and reducing study start-up cycle times.

🏝️ Benefits

• Remote work arrangement

• Full-time employment