Site Monitoring Lead, Germany

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

📋 Description

• Oversee site management, clinical monitoring, and central monitoring deliverables with a focus on patient safety, compliance with protocols/GCP/regulatory standards, and maintaining data integrity.

• Manage site interactions from the post-activation phase through to site closeout, which includes patient recruitment and handling investigator payments.

• Identify potential risks in clinical trial management and devise or implement mitigation strategies.

• Review the study's scope of work, budget, and protocol details; ensure that CRAs/CeMs are aware of their contractual obligations.

• Communicate any timeline, quality, budget, or out-of-scope risks to the project manager.

• Engage in key meetings, contributing to discussions and presentations, including Kick Off Meetings.

• Act as a point of escalation for communications from investigator site staff and accompany CRAs to sites as necessary.

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

• Create and maintain clinical study tools and templates, including the Clinical Monitoring Plan.

• Ensure that CTMS, dashboards, and other systems are set up and accessible; oversee UAT and audits of access and trails.

• Facilitate training for the study team on protocols, CRFs, dashboards, SOPs, plans, data requirements, and timelines.

• Supervise CRA and Central Monitor resourcing, assignments, conduct, quality, and deliverables.

• Examine oversight dashboards and clinical trial systems such as CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, and central monitoring dashboards.

• Ensure compliance with monitoring strategy, CMP/SMP, and risk management plans.

• Review monitoring documentation for both site and central monitoring, ensuring timely delivery and effective risk communication.

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

• Support inspection readiness for activities related to clinical trial management.

• Supervise CRAs and Central Monitors, assess compliance, pinpoint emerging risks, and assist in corrective action plans.

• Aid in activities necessary to meet data cut and database lock deadlines.

• Offer performance feedback to line managers.

• Coordinate clinical activities for CTM teams on larger or more complex trials.

• Mentor and coach CTMs on clinical delivery, project risks, and the implementation of actions.

⛳️ Requirements

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

• Proven ability to lead and align teams to achieve project milestones.

• Demonstrated experience working in an international setting.

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

• Preferred experience with risk-based monitoring methodologies.

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

• Experience in oncology is desirable.

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

• Proficient computer skills.

• Strong skills in conflict resolution.

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

• Critical thinking skills to identify causes and appropriate solutions.

• Moderate travel may be required, approximately 20% of the time.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Peer recognition programs.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Option for remote work (with prior approval).