Sponsor Dedicated Local Sr Clinical Trial Manager - Neurology // Home Based Spain

Syneos Health Commercial Solutions

1mo ago

Job
Full-time
Senior Level
Science
Healthcare
Barcelona

AI generated summary

You need a related Bachelor's/RN, experience in Neurology studies, site management, conflict resolution skills, and knowledge of GCP/ICH. Moderate travel may be required.
You will oversee site management and monitoring, ensure protocol compliance, assess risks, coordinate training, and manage team performance while maintaining data integrity and patient safety.

Requirements

Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
Experience in management of Neurology studies
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
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%

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) 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. 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 or may coordinate clinical activities for a team of CTMs across a portfolio of projects.
May coach and mentor CTMs regarding functional clinical delivery, evaluation of project risks, and action implementation.

FAQs

Is neurology experience required for this position?

Yes, neurology experience is required.

What type of work environment does this position offer?

This position is home-based and allows for remote work from Spain.

What qualifications are necessary for applying to this role?

A Bachelor's degree or RN in a related field, or an equivalent combination of education, training, and experience is required.

Will there be any travel required for this position?

Yes, moderate travel may be required, approximately 20%.

What are the main responsibilities of the Sponsor Dedicated Local Senior Clinical Trial Manager?

Responsibilities include site management oversight, clinical monitoring, patient safety, regulatory compliance, risk assessment, and ensuring the quality of clinical deliverables.

Is experience in risk-based monitoring preferred for this position?

Yes, preferred experience with risk-based monitoring is desired.

What skills are important for this role?

Important skills include conflict resolution, problem-solving, critical thinking, and the ability to lead teams in achieving project milestones.

How does Syneos Health emphasize diversity and inclusion in the workplace?

Syneos Health is committed to bringing together diversity of thoughts, backgrounds, cultures, and perspectives, creating a place where everyone feels they belong.

What kind of training will be provided for the study team?

The role includes coordinating initial and ongoing training regarding protocol specificities, Case Report Form (CRF) completion, and related clinical plans and guidelines.

What tools and systems will I be expected to use in this role?

You will be expected to use various clinical study tools and templates, including CTMS, EDC, eDiary, ePROs, and other clinical trial management systems.

Syneos Health Commercial Solutions

Science & Healthcare

Industry

10,001+

Employees

Mission & Purpose

Syneos Health® (Nasdaq:SYNH) is the only 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. We bring together a talented team of professionals, who work across more than 110 countries, with a deep understanding of patient and physician behaviors and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment.