Project Manager II, Early Phase (Canda)

Oversees the quality of project deliverables, including vendor and subcontractor outputs, and drives continuous improvement in training, execution, and quality processes.

Evaluates differences between planned and actual project outcomes and implements corrective actions when required.

Ensures study-specific training matrices are customized, maintained, and up to date.

Verifies that all team members and service providers receive adequate project training and that training records remain current.

Reviews and approves responses to quality assurance audits to ensure compliance with company procedures and regulatory requirements.

Ensures key study documents and deliverables, such as protocols, informed consent forms, eCRFs, source document templates, tables/listings/figures, and clinical study reports, are completed on schedule and meet study requirements.

Oversees the filing, maintenance, and archiving of study documentation within the TMF in compliance with company SOPs and regulatory requirements.

Provides project status updates while ensuring compliance with budgets, scope, timelines, SOPs, Good Clinical Practice (GCP), regulatory requirements, and study-specific procedures.

Tracks recruitment performance and develops mitigation plans when enrollment timelines are at risk.

Participates in the planning and execution of Investigator Meetings.

Works with Regulatory Affairs to ensure ethics submissions are completed on time and that essential documents are collected and maintained throughout the study.

Ensures the TMF remains complete, accurate, and inspection-ready at all times.

May oversee clinical monitoring activities, including site qualification, initiation, routine monitoring, and close-out visits, as well as CRA training and monitoring oversight.

Supports study sites and ensures they have the necessary materials and resources to conduct the study effectively.

Collaborates with Data Management to ensure CRFs meet protocol and sponsor requirements and that data review and query resolution remain on schedule through database lock.

Partners with Clinical Operations to ensure monitoring activities are completed according to sponsor expectations, SOPs, regulations, GCP, and study requirements.

Contributes to the development of Clinical Monitoring Plans.

Provides project-specific training to Clinical Research Associates (CRAs) and may conduct site initiation visits for single-site studies.

Develops annotated site visit reports and monitoring tools, including source data verification worksheets.

May mentor junior staff and support the onboarding of new employees.

Provides technical, therapeutic, and project management expertise to support departmental training and process improvement initiatives.

May participate in business development activities, including client meetings, proposal defenses, RFIs, and RFP responses.

May contribute to process improvement initiatives, including the development, testing, and implementation of operational tools and processes.