Clinical Trial Manager II - Study Manager in RWE (Poland, Bulgaria, UK, Romania, Spain) - Spons[...]

Syneos Health, Inc.; Madrid; Presencial; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A leading biopharmaceutical solutions organization is seeking a Clinical Trial Manager II for their Madrid office. The role includes overseeing site management and ensuring protocol compliance across clinical trials. Candidates should possess a Bachelor’s degree and strong site management skills. The position also involves risk-based monitoring, team collaboration, and delivering operational results. This opportunity offers a chance to significantly impact clinical research and improve patient outcomes.

Formación

• Demonstrated ability to lead and align teams in the achievement of project milestones.
• Must demonstrate good computer skills.
• Demonstrated expertise in site management and monitoring (clinical or central).

Responsabilidades

• Responsible for site management oversight, clinical monitoring and central monitoring.
• Reviews study scope, budget and protocol content.
• Escalates risks to project manager.
• Collaborates with other functional leaders to meet study milestones.

Conocimientos

Site management

Clinical monitoring

Risk-based monitoring

Problem-solving

Good communication

Educación

Bachelor’s degree or RN in a related field

Descripción del empleo

Clinical Trial Manager II - Study Manager in RWE (Poland, Bulgaria, UK, Romania, Spain) - Sponsor-dedicated

Updated: Yesterday
Location: Madrid, Spain
Job ID:25104652-OTHLOC-3529-2DMAD-2DR

Description

Clinical Trial Manager II - Study Manager in RWE (Poland, Bulgaria, UK, Romania, Spain) - Sponsor-dedicated is a full time position for an experienced Clinical Trial Manager with a background in RWE and clinical monitoring or central monitoring for late stage clinical studies. The Clinical Trial Manager II leader is a hard working team player needed to oversee site management oversight with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. He or she will partner with functional leaders to help keep the study’s schedule and the trial deliverables on track. This individual will help the study design and care of the study for the investigator and site assessment and execution, and the scope of work and go‑to procurement flows. Candidate should have a background in RWE and clinical monitoring or central monitoring for late stage clinical studies. The candidate will assist in handling site selection and site close out for the project. The leader will help oversee the pipeline of site close out process and data management templates and the close out timeline. The leader will also handle risk based monitoring and identify risks to the study. This is a high level position for an experienced Clinical Trial Manager for a large worldwide clinical development organization. The Clinical Trial Manager II will need to have knowledge of risk based monitoring and identify risks and risk mitigation runs. The responsibilities are not a small cut out, but it is a full length CV that includes core responsibilities to be able to be applied. The Clinical Trial Manager II will be part of the team to help keep the study’s schedule and the trial deliverables on track. The role may include a variety of tasks and responsibilities at the study level and a team environment. The Clinical Trial Manager II leader will need to help partner with functional leaders at the study level or the functional area. The Clinical Trial Manager II will have knowledge of risk based monitoring. The candidate will also handle site close out processes or data management templates on the go. He or she will stay in the clinical trial organization. The leader will help partner with functional leaders about the study’s schedule and the trial deliverables at the study level and the functional scope. The leader will also provide day to day data review, oversight and the schedule of the study. The need for risk based monitoring or close out process for each site will be part of the day to day schedule. The Clinical Trial Manager II leader will need to handle the risk based monitoring or risk mitigation. The candidate will also handle resource allocation and the schedule for the project. The Clinical Trial Manager II will be part of the overall team. The Clinical Trial Manager II should have a background in RWE, clinical monitoring or central monitoring for late stage clinical studies. The candidate will assist the study with the design under the scope for the care of the study and the end of the study. The candidate will help keep the study in the squad details. The Clinical Trial Manager II will manage the leadership of the study. The Clinical Trial Manager II leader will help partner with the functional leaders about the study schedule and scope and the day to day monitoring of the study. The candidate should be prepared to provide the support for the study and include the end of the study. The Clinical Trial Manager II leader will help manage the engagement of the study. The Clinical Trial Manager II will have a background in RWE and a plan for the outreach and the study. The Clinical Trial Manager II leader is the focus for the study and the assignment of the outreach. The Clinical Trial Manager II will help manage the assignment of the study schedule and manage the data management portion of the project and the study at the line mention about the assignments. The Clinical Trial Manager II leader will manage the schedule for the study when the study has been scheduled. The Clinical Trial Manager II will help identify the risk based monitoring for the center and the study. The Clinical Trial Manager II will help manage the study and the risk mitigation. The Clinical Trial Manager II leader is a large open job and can help partner with the functional leaders to provide the risk mitigation. The Clinical Trial Manager II villain will manage the schedule, the monitoring and the study along with the day to day schedule. The clinical trial management and the risk mitigation will also help manage the study. The clinical trial management is a large open role that can help the study to manage the risk based monitoring or the schedule for the study. The candidate will help manage the risk mitigation and the schedule of the study.

Job 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/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.
• Participates and presents in key meetings such as Kick Off Meeting.
• 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. Reviews and provides feedback on other functional plans (e.g. 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. Ensures access and audit trail reviews are conducted as required.
• 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. Document requested revisions and approvals in CTMS. 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.
• Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations. 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. May be assigned to larger,more complex trials.

Qualifications:

• 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
• Strong conflict resolution skills
• 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.
• Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues
• 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.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

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Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. 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.

Summary

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. Impact and ContributionIncludes executives as well as managers, supervisors and team leads providing strategic vision and/or tactical direction across a discipline and/or broader organization. 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. Supervises experienced support employees and/or entry individual contributors. 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.

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