Description
Clinical Trial Manager - Sponsor dedicated - Based in Rueil Malmaison
Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
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 deliver – for one another, our customers, and, most importantly, for those in need.
Discover what your 25,000 future colleagues 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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
Job Responsibilities
Here at Syneos Health, we are looking for a Clinical Trial Manager to work sponsor dedicated. You will have the chance to work in exciting studies in oncology. The job location will be Client Based at Rueil Malmaison / 50% Home Based.
You will be Responsible for study oversight and delivery management (time, budget, quality) at country level from start-up to closure. You will serve as the main point of contact at a country level for internal and external stakeholders.
Job Key Duties and Responsibilities:
- Coordinates country cross functional teams and acts as the main point of contact for a Country with the protocol manager and other global study team members
- Coordinates with other internal roles in country and site feasibility process, including proposal and validation of country study targets
- Develops country level patient recruitment strategy & risk mitigation. Coordinates and ensures country level study enrolment targets and timelines are met
- Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s
- Assessment and set up the of vendors during study start up period (locally)
- Investigator Meeting participation and preparation
- Ensures data entered in Clinical Trial Managements Systems is current and complete and access to eDC and vendor systems is available for the Country and clinical trial site personnel
- Validation of study related materials (i.e. protocol, ICF, patient material)
- Responsible for preparing country specific documents (e.g. global country specific amendment)
- Prepares materials for Site Initiation Visits
- Responsible for verifying and confirming with local team eTMF completeness (Country and Site level)
- Reviews Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues.
• Coordination of database locks and query follow up. Ensures timelines are met. • Ensure inspection readiness of assigned trials within country. Provide support to Health Authority inspection and pre-inspection activities
- Coordinates, develops and writes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation and completion.
- Lead study team meetings locally
- Reviewing and approving payments (based on GOA) and manage patient compensation claims (if applicable)
- Management of Site relationships (includes CRO related issues)
- May perform site closure activities, including post-close out
- May act as point of contact for Sites
- May support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees and other relevant instances.
Qualifications:
- Minimum qualifications posted above
- Thorough understanding of GCP, ICH Guidelines and Country regulatory environment
- In depth knowledge and understanding of clinical research processes, regulations and methodology
- Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management
- Demonstrated organizational and planning skills and independent decision-making ability
- Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives
- Strong organization and time management skills and ability to effectively manage multiple competing priorities
- Ability of critical thinking and risk analysis
- Strong communication skills with a strong customer focus, able to manage both internal and external clients at all organizational levels
- Skilled in the use of technology
Benefits
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Competitive remuneration package with excellent benefits
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Commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization
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Opportunity to work within a successful and rewarding environment
Are you interested?
If you are interested in this role and you believe you would be the right fit, we would be more than happy to hear from you. You can apply online.
To find out more about our company and search and apply for other open jobs please visit our website https://www.syneoshealth.com/
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About us:
Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 24,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform.
Disclaimer:
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.
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.
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.
