Clinical Trial Manager, dedicated

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

📋 Description

• Provide oversight for site management, clinical monitoring, and central monitoring deliverables.

• Prioritize patient safety, protocol adherence, Good Clinical Practice (GCP), regulatory compliance, and data integrity.

• Manage site interactions from activation to closeout, including recruitment strategies and investigator payments when necessary.

• Identify risks associated with clinical trials and devise or implement mitigation strategies, including those related to RACT.

• Review the study scope, budget, protocol content, and contractual commitments.

• Escalate risks related to timelines, quality, budget, and out-of-scope issues to the project manager.

• Participate in and present during critical meetings, including Kick-Off Meetings.

• Act as a point of escalation for communications with investigator sites and accompany Clinical Research Associates (CRAs) to sites when required.

• Collaborate with Study Start-Up, Patient Recruitment, Data Management, and other teams to achieve study milestones.

• Develop and maintain tools and templates for clinical studies, including the Clinical Monitoring Plan.

• Ensure that Clinical Trial Management Systems (CTMS), dashboards, and other systems are properly configured and accessible, including User Acceptance Testing (UAT) and audit trail reviews.

• Coordinate training on protocols, Case Report Forms (CRF), dashboards, Standard Operating Procedures (SOP), clinical plans, data plans, and timelines for study teams.

• Oversee the resourcing, assignments, conduct, compliance, and deliverable quality of CRAs and Central Monitors.

• Review oversight dashboards and clinical trial systems such as CTMS, Electronic Data Capture (EDC), electronic diaries (eDiary), electronic Patient Reported Outcomes (ePROs), Trial Master Files (TMF), Interactive Voice Response Systems (IVRS/IWRS), and central monitoring dashboards.

• Ensure that monitoring strategies, Clinical Monitoring Plans (CMP) / Site Monitoring Plans (SMP), risk management plans, and protocol requirements are comprehended and adhered to.

• Review documentation from site and central monitoring and ensure timely and compliant delivery.

• Provide updates on deliverables and risks to clients, project management, and leadership.

• Support readiness for inspections, corrective action plans, data evaluations, and database lock timelines.

• Offer performance feedback on staff to line managers.

• Coordinate clinical activities across various portfolios and mentor Clinical Trial Managers (CTMs) when assigned.

⛳️ Requirements

• Bachelor’s degree or Registered Nurse (RN) in a relevant field or an equivalent combination of education, training, and experience.

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

• Demonstrated experience working in an international environment.

• Established expertise in site management and monitoring, whether clinical or central.

• Preferred experience in risk-based monitoring.

• Understanding of financial principles related to clinical trial management and budget oversight.

• Knowledge of Good Clinical Practice (GCP) / International Council for Harmonisation (ICH) Guidelines and other relevant regulatory requirements.

• Proficient computer skills.

• Strong skills in conflict resolution.

• Ability to implement problem-solving techniques to address complex issues and employ a risk management approach.

• Critical thinking skills to identify causes and appropriate solutions when issues arise.

• Moderate travel may be required, approximately 20%.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• An inclusive organizational culture.

• Reasonable accommodations provided when appropriate.