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Global Clinical Trial Manager - Oncology (Cell & Gene Therapy preferred) - anywhere in EMEA



Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

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.

Discover what our 29,000 employees, across 110 countries already know:

Why Syneos Health

  • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
  • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  • We are continuously building the company we all want to work for and our customers want to work with. Why? 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.

Job responsibilities

The Clinical Trial Manager II (CTM II) serves as the clinical functional lead, accountable for the delivery of
site management, clinical monitoring and central monitoring of assigned study(ies). A CTM II is expected
to independently manage the clinical and central monitoring team members, but may serve as a regional
clinical lead on larger trials under the direction of a global Sr CTM. The position as defined by scope
provides leadership, problem-solving, mentoring, and technical support to the Clinical Operations team to
ensure compliance with the monitoring plan as well as ensures timeliness and quality of deliverables
within the specified budget.

• 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 (eg. 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 (eg. 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
• 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
• May be assigned to larger, more complex trials


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 .

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.

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and
• 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
• 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
• Moderate travel may be required, approximately 20%


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