Sponsor Dedicated Clinical Trial Manager - Home based Israel

Description

Sponsor Dedicated Clinical Trial Manager - Home based Israel

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.
  
  

Overview

Job Responsibilities

The role will be accountable for overseeing and maintaining country (Israel) deliverables as part of the overall project plan. Manages and maintains accurate country level plans.

Ensures timely communication bidirectionally between the global and local study team. Cluster focused stakeholder management.

Main Responsibilities

• Responsible for documented review for reports/issues written by the CRAs/Lead CRAs.
• Drives recruitment at regional/country level
• Responsible for local country vendor management and oversight (as applicable).
• Drives data cleaning at regional/country level
  
  

Requirements

• At least 3 years of previous experience as Clinical Trial Manager
• Previous experience with Israeli sites and knowledge of Israeli RA contacts and regulatory and Submissions processes
• Fluency in English and Hebrew

• Background & Expertise:
• Preferably with historical CRA or strong site-level experience
• Solid understanding of site operations and dynamics.
• Start-Up Phase Experience:
• Involvement in site selection, feasibility assessments, timeline planning, and recruitment support.
• Experience working with vendors during study setup.
• Conduct Phase Responsibilities:
• Ability to support the study team during audits, inspections, and query resolution.
• Strong leadership skills to manage complex or challenging conversations.
• Experience in Oncology field and across different study phases is highly preferred
• Local Knowledge & Language:
• Deep understanding of local (Israeli) regulatory and ethics processes.
• Fluency in Hebrew and English
  

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.

Summary

Roles within the Clinical Trial Management job family at the M24 level serves as the clinical functional lead, accountable for the delivery of site management, clinical monitoring and central monitoring of assigned study(ies). 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. The Senior CTM may provide direction, oversight and coordination of CTM(s) working across regions and/or countries to ensure clinical project and site deliverables are met.