Description
Senior Clinical Trial Manager (Sponsor dedicated)
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.
Job Responsibilities
* Oversee the development, coordination, and implementation of Phase 1 clinical research studies at the organization's facilities, ensuring that all aspects of the trial are conducted efficiently and effectively
* Collaborate with principal investigators, research subjects, client teams, investigators, and clinic operations teams to facilitate communication and coordination, ensuring that all parties are aligned and informed throughout the trial process
* Plan logistics and resource usage for clinical trials, including the allocation of staff, equipment, and materials, to ensure that trials are conducted smoothly and without delays
* Track study progress in alignment with project milestones, client deliverables, and budget, using project management tools and techniques to monitor and report on the status of the trial
* Ensure compliance with applicable regulations globally and by region, including adherence to Good Clinical Practice (GCP) guidelines, ethical standards, and regulatory requirements, to maintain the integrity and quality of the trial
* Manage a team of individual contributors and supervisors, providing strategic vision and tactical direction, setting goals and objectives, and monitoring performance to ensure that the team operates effectively and achieves its targets
* Deliver operational results that have direct impact on immediate or short-term department outcomes, using data-driven decision-making and problem-solving skills to address challenges and optimize trial performance
* Provide in-depth knowledge and skills within the scientific/technology or professional discipline, understanding the impact of work on related areas, and leveraging expertise to contribute to the advancement of the organization's research objectives
* Utilize practical knowledge in managing the execution of processes, projects, and tactics within the team, ensuring that all activities are conducted in accordance with established protocols and procedures
Qualifications:
* Bachelor's degree in a relevant scientific or healthcare field; advanced degree preferred
* Minimum of 5 years of experience in clinical trial management, with a focus on Phase 1 studies
* Proven track record of managing clinical trials and delivering successful outcomes
* Strong understanding of global and regional regulations related to clinical research
* Excellent organizational, planning, and resource management skills
* Ability to lead and manage a team, providing strategic vision and tactical direction
Certifications:
* Certified Clinical Research Professional (CCRP) or equivalent certification preferred
* Project Management Professional (PMP) certification is a plus
Necessary Skills:
* In-depth knowledge of clinical trial processes and regulations
* Strong leadership and team management skills
* Excellent communication and collaboration abilities
* Proficiency in project management and resource planning
* Ability to analyze and interpret complex data
* Strong problem-solving and decision-making skills
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.
Summary
Novo requires a minimum of (7) years of experience in operational aspects of planning and conducting clinical trials with a minimum of (4) years of experience in project management of clinical trials at regional level (e.g. multi country set-up). This role will manage a range of 4-5 studies, with at least 1 under recruitment. Client is looking for someone that really understand the role, has strong initiative and relationship building skills and knows how to communicate with influence to create collaboration with internal and external stakeholders, experience in Diabetes trials highly appreciated. Travel will be required, therefore candidate will need to be located within reasonable distance from an airportRoles 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 ContributionRoles 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