Clinical trial manager F/H

Clinical Trial Manager II
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique 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. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Why Syneos Health
technical and therapeutic area training; We are continuously building the company we all want to work for and our customers want to work with. Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

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. 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/Central Monitors) is aware of the contractual obligations and parameters.
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 clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope.
Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. This may include accompanying CRA team members to sites for observation or conflict resolution.
Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines. Data Management Plan, Communication Plan) as they relate to the 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 use by the clinical team, including overseeing user acceptance testing (UAT) as needed. Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study.
Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality.
Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools.
Reviews the 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 oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan.
Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan. Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans.
Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity. Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines.
Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables. Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements. Provides solutions for obstacles in protocol execution and site management.
This may include data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA). Supports Inspection Readiness for clinical trial management scope.
Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks. May develop and support execution of corrective action plans at site and study level. Supports and completes activities to achieve data cut and lock deadlines.
Provides feedback to line managers on staff performance including strengths as well as areas for development. Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
Demonstrated ability to lead and align teams in the achievement of project milestones
Demonstrated capability of working in an international environment.
Demonstrated expertise in site management and monitoring (clinical or central)
Preferred experience with risk-based monitoring
Demonstrates understanding of clinical trial management financial principles and budget management
Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
Must demonstrate good computer skills
Good communication, presentation and interpersonal skills among project team and with sites
Demonstrated ability to apply problem solving techniques to resolve complex issues, and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.
Moderate travel may be required, approximately 20%

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

Learn more about Syneos Health.

Further, nothing contained herein should be construed to create an employment contract. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Roles within the Clinical Trial Management job family are responsible for all aspects of the development, coordination, and implementation of Phase 1 clinical research studies at the organization's facilities. Collaborates with the principal investigator, liaisons between research subjects, client teams, investigators, and clinic operations teams, and plans logistics and resource usage. Tracks study progress in alignment with project milestones, client deliverables, and budget, and follows applicable regulations globally and by region.
The majority of time is spent overseeing their area of responsibility, planning, prioritizing, and/or directing the responsibilities of employees. Goal are achieved through management of process, policy, and performance of direct and/or indirect reports. Delivers operational results that have moderate impact on the immediate achievement of results for the team. Broad job knowledge in an operational, administrative and/or specialized field, adapts new procedures, techniques, tools, etc. Understands basic management approaches such as work scheduling, prioritizing, coaching and process execution.