Clinical Trial Manager II – Country Study Lead

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

📋 Description

• Accountable for overseeing site management, clinical monitoring, and central monitoring deliverables, emphasizing patient safety, adherence to protocol/GCP/regulatory standards, and data integrity.

• Manages site interactions from activation to closeout, which may involve patient recruitment, investigator payments, or other related tasks.

• May be tasked with identifying critical data and processes, protocol execution risks, and risk mitigation strategies as part of the Risk Assessment and Categorization Tool (RACT).

• Reviews the study's scope of work, budget, and protocol details to ensure the clinical project team (CRAs/CeMs) understands the contractual obligations and parameters.

• Leverages previous clinical experience, operational data, metrics, and reports to pinpoint risks to clinical trial management deliverables.

• Alerts the project manager to any risks affecting clinical trial management deliverables (timeline, quality, and budget) and activities that fall outside contracted scope.

• Utilizes strategic thinking and problem-solving abilities to propose and execute risk mitigations.

• Engages in and presents at critical meetings such as the Kick-Off Meeting.

• Acts as an escalation point for communication with investigator site staff and may need to interact directly with principal investigators or other site personnel, either by phone or in person.

• This may involve accompanying CRA team members to sites for observation or conflict resolution.

• Collaborates with other functional leaders, including Study Start-Up, Patient Recruitment, and Data Management, to coordinate delivery handoffs and achieve key study milestones such as site activation targets, enrollment goals, and database lock timelines.

• Reviews and provides insights on other functional plans (e.g., Data Management Plan, Communication Plan) as they relate to clinical trial management activities.

• Responsible for creating and maintaining clinical study tools and templates, including the Clinical Monitoring Plan.

• Ensures that CTMS, dashboards, and other systems are set up and accessible for the clinical team, including overseeing user acceptance testing (UAT) as necessary.

• Conducts access and audit trail reviews as needed.

• Coordinates initial and ongoing training for the study team on protocol details, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans, and timelines for the study.

• Oversees resource allocation for CRAs and Central Monitors, site assignments, and the conduct of study team members, identifying risks to delivery or quality.

• Ensures the quality of clinical monitoring, central monitoring, and site management deliverables within a project while maintaining proper visibility of progress using approved systems and/or tracking tools.

• Reviews project oversight dashboards and other clinical trial systems (e.g., Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards) to monitor site and patient activities, study team conduct, and ensure timely data updates reflecting the execution of all operational aspects (required visits/calls, duration, and frequency) as planned.

• Comprehends the monitoring strategy required for the study and, when necessary, participates in the formulation of the study risk assessment plan.

• Is responsible for ensuring their assigned clinical team members’ understanding, ongoing compliance, and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans.

• Evaluates the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports, and relevant correspondence) to confirm they accurately reflect site management activities and convey any risks to protocol/GCP compliance, trial conduct, patient safety, or data integrity.

• Records requested revisions and approvals in CTMS.

• Ensures these deliverables meet company and/or sponsor specifications, including delivery deadlines.

• Engages with clients and other functional departments regarding clinical monitoring, central monitoring, and site management activities and deliverables.

• Provides status updates on clinical deliverables and risks to clients, project management, and leadership as per departmental or study agreements.

• Proposes solutions to challenges in protocol execution and site management.

• Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP, and country regulations.

• This may encompass data management, study start-up, patient recruitment, medical monitoring, pharmacovigilance, and Quality Assurance (QA).

• Supports Inspection Readiness for the scope of clinical trial management.

• Oversees CRAs and Central Monitors assigned to the study, regularly assessing study-specific process and training compliance, CMP compliance, and identifying emerging risks.

• Develops and aids in executing corrective action plans at both the site and study levels.

• Supports and completes tasks to meet data cut and lock deadlines.

• Provides feedback to line managers on staff performance, highlighting strengths and areas for improvement.

• May be assigned to larger, more complex trials or may coordinate clinical activities for a team of CTMs across a portfolio of projects.

• May coach and mentor CTMs in functional clinical delivery, evaluation of project risks, and action implementation.

⛳️ Requirements

• Bachelor's degree or RN in a related field or an equivalent combination of education, training, and experience.

• Proven ability to lead and align teams towards achieving project milestones.

• Demonstrated capability to work effectively in an international environment.

• Proven expertise in site management and monitoring (clinical or central).

• Preferred experience with risk-based monitoring.

• Demonstrates knowledge of clinical trial management financial principles and budget management.

• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Must exhibit strong computer skills.

• Excellent conflict resolution abilities.

• Proven capability to apply problem-solving techniques to address complex issues and employ a risk management approach to identify and mitigate potential threats to successful clinical research project execution.

• Demonstrates critical thinking to identify the cause and appropriate solution for issues.

• Moderate travel may be required, approximately 20%.

🏝️ Benefits

• We are dedicated to developing our employees through career growth and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition; and a total rewards program.

• We are committed to fostering an inclusive culture where you can be your authentic self. Our purpose – Driven to Deliver – embodies our colleagues' passion to show up every day and create solutions that can significantly impact someone’s life.

• We are continually working to build the company that we all aspire to work for and that our customers wish to collaborate with.