Why Syneos Health
• #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• 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

Here at Syneos Health we are looking for a Study Start Up Project Lead to work within the team of our global Pharma client.

Job role:

SSU PL (Clinical Operations Manager) is accountable for execution and oversight of local operational clinical trial activities in a country for assigned protocols in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally.

- Work closely with the Senior SSU PL (COM) and local GCTO country operation to assess, prioritize and drive execution of specific clinical trials in order to support and manage the pipeline and local business needs to agreed timelines and budgets.

- Develop local language materials including local language Informed Consents and translations. Execute and oversee country submissions and approvals for assigned protocols.

- Develop, negotiate and complete Clinical Trial Research Agreements (CTRA).Oversee and track clinical research-related payments.

- Pro-actively identify issues and risks, analyze root cause, and propose solutions to problems and escalate to management as applicable.Qualifications:

- Master's degree in Medicine/Life Sciences

- Min. 5 years of experience in clinical research

- Extensive experience in clinical research operations and with project management and coordination

- Expertise of core clinical systems, tools and metrics

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 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.

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.

#LI-KU1