Single Sponsor Sr Clinical Trial Manager (Global Site Management) UK based - fully home based
Syneos Health
Date: 2 days ago
Contract type: Full time
Remote
Description
Single Sponsor Sr Clinical Trial Manager (Global Site Management) UK based - fully home based
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.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
This Global Sr CTM role provides direction and operational expertise for all Clinical Site Management (CSM) integrity, quality, and timeliness of activities in assigned studies. The position can be assigned as the global study strategy leader serving as the overall Clinical Site Management functional leader and single point of accountability for study level CSM deliverables or can be assigned as an area site execution leader to manage area level site management activities in collaboration with an assigned global study strategy leader dependent on size, complexity, and geographic scope of assigned studies. Working within a strong portfolio of Oncology studies. Influences and aligns within Clinical Development Operations, with the assigned global site management leader if applicable, and other key stakeholders in assigned studies. If assigned as the global site management leader, is a key member of the Clinical Study Team representing CSM globally.
Qualifications
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.
http://www.syneoshealth.com
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 at the M24 level are responsible for overseeing all aspects of Phase 1 clinical research studies at the organization's facilities. This involves collaboration with the principal investigator, liaisons between research subjects, client teams, investigators, and clinic operations teams. The manager plans logistics and resource usage, tracks study progress in alignment with project milestones, client deliverables, and budget, and ensures compliance with applicable regulations globally and by region. Impact and Contribution Roles within the Clinical Trial Management job family at the M24 level play a pivotal role in the successful execution of clinical trials, directly impacting the organization's ability to deliver high-quality research outcomes. By managing a team of individual contributors and supervisors, the manager ensures that operational results have a direct impact on immediate or short-term department results. Their in-depth knowledge and skills within the scientific/technology or professional discipline contribute to the understanding of the impact of work on related areas. The manager's strategic vision and tactical direction across the discipline and broader organization are crucial for achieving goals through the management of processes, policies, and performance of direct and indirect reports. Core Focus
Single Sponsor Sr Clinical Trial Manager (Global Site Management) UK based - fully home based
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.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
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.
This Global Sr CTM role provides direction and operational expertise for all Clinical Site Management (CSM) integrity, quality, and timeliness of activities in assigned studies. The position can be assigned as the global study strategy leader serving as the overall Clinical Site Management functional leader and single point of accountability for study level CSM deliverables or can be assigned as an area site execution leader to manage area level site management activities in collaboration with an assigned global study strategy leader dependent on size, complexity, and geographic scope of assigned studies. Working within a strong portfolio of Oncology studies. Influences and aligns within Clinical Development Operations, with the assigned global site management leader if applicable, and other key stakeholders in assigned studies. If assigned as the global site management leader, is a key member of the Clinical Study Team representing CSM globally.
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
- 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
- Oncology would be beneficial. Moderate travel may be required, approximately 20%
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.
http://www.syneoshealth.com
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 at the M24 level are responsible for overseeing all aspects of Phase 1 clinical research studies at the organization's facilities. This involves collaboration with the principal investigator, liaisons between research subjects, client teams, investigators, and clinic operations teams. The manager plans logistics and resource usage, tracks study progress in alignment with project milestones, client deliverables, and budget, and ensures compliance with applicable regulations globally and by region. Impact and Contribution Roles within the Clinical Trial Management job family at the M24 level play a pivotal role in the successful execution of clinical trials, directly impacting the organization's ability to deliver high-quality research outcomes. By managing a team of individual contributors and supervisors, the manager ensures that operational results have a direct impact on immediate or short-term department results. Their in-depth knowledge and skills within the scientific/technology or professional discipline contribute to the understanding of the impact of work on related areas. The manager's strategic vision and tactical direction across the discipline and broader organization are crucial for achieving goals through the management of processes, policies, and performance of direct and indirect reports. Core Focus
- Overseeing the development, coordination, and implementation of Phase 1 clinical research studies
- Collaborating with principal investigators, research subjects, client teams, investigators, and clinic operations teams
- Planning logistics and resource usage for clinical trials
- Tracking study progress in alignment with project milestones, client deliverables, and budget
- Ensuring compliance with applicable regulations globally and by region.
- Managing a team of individual contributors and supervisors
- Delivering operational results that impact immediate or short-term department outcomes
- Providing strategic vision and tactical direction across the discipline and broader organization
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