Sr Project Specialist (Sponsor Dedicated/Hybrid, Burlington, Ontario, Canada 50% onsite)

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

Responsible for planning, coordination and conduct of trial activities according to 
ICH-GCP. Assures the seamless conduct of trials within the defined timelines in 
close coordination and communication with the Clinical Trial Leader (CTL). 
• Collaborate and interact trial team members, Local Clinical Trial Managers (CTM) 
and interface functions (e. g. Clinical Trial Supplies Unit, Sourcing, others) 
Cooperation with external functions (e. g. Clinical Research Organizations, advisors, investigators) to conduct clinical trials. 
• Independently manage correspondence, complex reports, tracking tools and budget overviews in English language. 
• Address and answer complex questions from global and local trial teams and trial sites 
• Support the planning of clinical trial supplies. 
• Keep overview of records and update of records to address local regulatory 
demands from Ethics/Authorities to ensure timely submission and re-submission. Collaborate in internal/external audits. 
• Organization and supervision of all trial related wrap-up activities (e. g. data 
cleaning) 
• Ensure the appropriate set-up and maintenance of internal and external systems and tools. 
• Support the trial team by compiling data for internal and external reporting purposes and tracking of trial relevant information. 
• Proactive engagement and initiative, and contribution of own experience in global and local initiatives for improvement in respect to structures, processes, system and guidelines and development of solutions and new approaches in global context. Represent CTOS in working groups and committees, as needed

• Bachelor’s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience
• Moderate relevant clinical research experience with an understanding of clinical drug development and clinical trial operations.  Experience in a therapeutic group preferred - Immunology or Oncology
• Strong knowledge of GCP/ICH guidelines and other applicable regulatory requirements
• Ability to perform several tasks simultaneously to meet deadlines.  Self-motivation and ability to work independently.
• High proficiency with full MS Office Applications and Veeva Vault
• Strong organizational, communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade

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.