Project Coordinator

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

📋 Description

• Collaborate with the project team to establish and uphold project schedules.

• Revise timelines in MS Project, CTMS, project governance tools, and other tracking systems; escalate risks related to timelines.

• Assist the Project Lead with reviews comparing timesheet data against budget, tracking and reconciling vendor finances, as well as sponsor contract financial monitoring and final project financial reconciliation.

• Conduct reviews comparing the Contract with the Study Plan alongside the Project Lead.

• Keep track of out-of-scope work and assist with the preparation of Change Order Forms.

• Manage vendor relationships and escalate any out-of-scope activities as necessary.

• Update tools for risk identification, issue resolution, risk assessment, and protocol deviations.

• Follow up on outstanding action items until they are resolved.

• Provide monthly updates to the Project Governance Tool.

• Aid in identifying, preventing, and closing quality compliance gaps.

• Support the preparation for audits and investigations, including the creation of issue storyboards.

• Assist in the timely resolution of audit and inspection Corrective and Preventive Actions (CAPAs).

• Facilitate communication within the study team by organizing meetings and maintaining logs, matrices, directories, distribution lists, SharePoint sites, mailboxes, and project trackers.

• Collaborate with support functions on TMF uploads, reviews, issue resolutions, systems access, project-specific training, and delegated tasks.

• Monitor, escalate, and assist in the enforcement of redaction for subject-sensitive information and identifiers within study documentation.

• Maintain the Lessons Learned tracker.

• Perform other assigned duties as necessary.

⛳️ Requirements

• A university or college degree (preferably in life sciences), or certification in a related allied health profession (such as nursing, medical, or laboratory technology) from an accredited institution.

• Alternatively, three (3) or more years of relevant clinical research experience in the pharmaceutical or CRO industries, or experience in a healthcare setting, will be taken into account.

• Equivalent relevant experience may be considered in lieu of educational prerequisites.

• 0–2 years of pertinent industry experience.

• Familiarity with ICH Guidelines and GCP, including international regulatory standards for clinical development programs, is preferred.

• Proficient in Microsoft Word, Excel, Project, Access, and PowerPoint.

• Capable of developing accurate study-related documents with minimal supervision.

• Excellent verbal and written communication skills.

• Must be able to work at a computer keyboard for 6–8 hours daily.

• Must be adaptable to changes in work assignments as business needs arise.

🏝️ Benefits

• Engaging, face-to-face continuous learning environment through the Project Management Academy.

• Mentorship and support from Project Leads, Line Manager, mentors, and subject matter experts.

• Opportunity to mentor other PM Academy Project Coordinators in your areas of expertise.