Clinical Trial Manager

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

📋 Description

• Manage and oversee the operational aspects of clinical investigative sites and the deliverables related to clinical operations for clinical trials.

• Train and supervise the activities of Clinical Research Associates (CRAs), including transitions.

• Identify quality issues and performance trends at sites, establishing corrective action plans as necessary.

• Ensure compliance with study plans, Standard Operating Procedures (SOPs), ICH/GCP guidelines, relevant regulations, laws, timelines, and budgets.

• Act as the primary contact for sponsors regarding site-specific operational concerns and clinical deliverables.

• Participate in internal, sponsor, and investigator meetings.

• Manage risk assessments and the execution of mitigation strategies.

• Oversee site contacts, provide training, monitor performance, and manage screening and enrollment processes.

• Track metrics from site visit reports and evaluate protocol deviations along with necessary action items.

• Develop the Monitoring Plan and assist in creating study plans, manuals, reference materials, logs, and site instructions.

• Prepare and deliver CRA training, coordinate and lead CRA meetings, and conduct quality assessments and co-monitoring visits.

• Oversee the development, performance, quality, and completion of Site Qualification Visits (SQV), Site Initiation Visits (SIV), Site Monitoring Visits (SMV), and Close-Out Visits (COV).

• Engage in business development efforts, including client meetings, bid defenses, Requests for Proposals (RFPs), and Requests for Information (RFIs).

• Contribute to tools and process enhancements within the department.

• Monitor, forecast, and reconcile project budgets, while supporting change orders and financial planning activities.

• Proactively identify challenges, propose solutions, and facilitate the delivery of clinical trials within established timelines and budgets.

• Leverage prior experience to address complex issues, identify potential solutions, and analyze outcomes.

⛳️ Requirements

• Sufficient experience and qualifications to effectively carry out assigned responsibilities.

• Comprehensive knowledge of the study protocol, therapeutic area, and specific indications.

• Familiarity with ICH/GCP guidelines, applicable regulations, laws, SOPs, and study-specific requirements.

• Proven experience in managing clinical monitoring activities and clinical investigative sites.

• Experience with site performance management, monitoring, KPI reviews, audit findings, and corrective action plans.

• Background in developing monitoring plans and other study-related documentation, manuals, reference materials, logs, and site worksheets/instructions.

• Experience in training, mentoring, and overseeing CRAs, Lead CRAs, and clinical operations personnel.

• Skilled in managing site screening, enrollment oversight, site visits, protocol deviations, and risk mitigation efforts.

• Familiarity with clinical trial budgets, forecasting, reconciliation, billed hours, out-of-scope work, and change orders.

• A valid work permit for Europe is required.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Comprehensive benefits package (including medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, and social activities).

• Continuous learning and development opportunities.

• Attractive opportunities for advancement.