Sr. Clinical Trial Manager (Clinical Research Medical Advisor) - FSP - Homebased Germany

Sr Clinical Trial Manager - Germany role at Syneos Health

Location: Munich, Bavaria, Germany.

Overview

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with problem solvers to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies to change lives.

Work here matters everywhere.

Responsibilities

• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities. May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).
• Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CeMs) are aware of contractual obligations. Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. Escalates to the project manager any risks to deliverables (timeline, quality, budget) and any activities out of contracted scope.
• Employs strategic thinking and problem-solving skills to propose and implement risk mitigations. Participates and presents in key meetings such as Kick Off Meetings.
• Serves as an escalation point for communications with investigator site staff and may interact with principal investigators or other site staff. May accompany CRA team members to sites for observation or conflict resolution.
• Collaborates with functional leaders to coordinate delivery handoffs and meet study milestones such as site activation targets, enrollment targets and database lock timelines. Reviews and provides feedback on other functional plans related to clinical trial management activities.
• Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. Ensures CTMS, dashboards and other systems are set up and available for the clinical team, including user acceptance testing (UAT) as needed. Ensures access and audit trails are reviewed as required.
• Coordinates initial and ongoing training to the study team regarding protocol specifics, case report form completion, dashboards, Sponsor SOPs, clinical plans and guidelines, data plans and timelines for the study.
• Oversees resourcing allocations for CRAs and Central Monitors, site assignments and team conduct, and identifies risks to delivery or quality. Ensures quality of monitoring deliverables and maintains progress visibility using approved systems and tracking tools.
• Reviews project oversight dashboards and clinical trial systems (CTMS, EDC, eDiary, ePROs, TMF, IVRS/IWRS, central monitoring dashboards) to oversee site and patient activities and ensure timely data updates according to plan.
• Understands the monitoring strategy for the study and participates in development of the study risk assessment plan. Ensures assigned team members understand and deliver according to CMP/SMP and risk plans.
• Reviews site and central monitoring documentation to ensure it reflects site management activities and conveys risks to protocol/GCP, trial conduct, patient safety or data integrity. Documents revisions and approvals in CTMS and adheres to deadlines.
• Interacts with the client and other functional departments regarding monitoring activities and deliverables. Provides status updates on deliverables and risks as per agreements. Proposes solutions for obstacles in protocol execution and site management.
• Demonstrates understanding of other functions’ roles to achieve compliance and delivery according to protocol, SOPs, ICH GCP and country regulations. Supports inspection readiness for clinical trial management scope.
• Oversees CRAs and Central Monitors and assesses process and training compliance. Develops and supports corrective actions at site and study level. Supports and completes activities to achieve data cut and lock deadlines.
• Provides feedback to line managers on staff performance and development areas.
• May be assigned to larger, more complex trials or coordinate activities for a team of CTMs across a portfolio of projects. May coach CTMs regarding delivery, risk evaluation and action implementation.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience
• Proven ability to lead and align teams to achieve project milestones
• Experience working in an international environment
• Expertise in site management and monitoring (clinical or central)
• Preferred experience with risk-based monitoring
• Understanding of clinical trial management financial principles and budget management
• Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements
• Strong computer skills and ability to use relevant systems
• Conflict resolution skills and problem-solving abilities
• Ability to apply risk management to identify and mitigate threats to trials
• Critical thinking to diagnose issues and determine solutions
• Moderate travel required, approximately 20%

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, across numerous studies and sites. This role offers opportunities to contribute to a dynamic, global organization.

For more information, visit the company website at .

Additional Information

Tasks, duties, and responsibilities as listed are not exhaustive. The company may assign other tasks at its discretion. This description is intended to reflect the general nature of the role and is subject to change. The company complies with applicable laws and regulations, including accommodation requirements when appropriate.

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