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clinical research project manager
Title posted on Jobillico - Sr Project Specialist
Posted on April 10, 2024 by Employer details Syneos Health
Job details
<div> <p><b>Description</b> </p> <p><strong>Senior Project Specialist - Ontario, Canada</strong></p> <p>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.</p> <p>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.</p> <p>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.</p> <p>Discover what our 29,000 employees, across 110 countries already know: <br><strong>WORK HERE MATTERS EVERYWHERE</strong></p> <p><strong>Why Syneos Health</strong></p> <ul> <li>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.</li> <li>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. </li> <li>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.</li> </ul> <p><strong>Job responsibilities</strong><br>? Set-up, maintain and close out project files and study information ((e.g., KPIs, regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), protocol deviations, site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems.<br>? Maintain and distribute study-specific /financial reports (e.g. vendor/site invoices, investigator payments (grants and pass-through), forecasts, etc).<br>? May lead internal and external meetings as directed by the PL Prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follows up with team members on action items to closure. <br>? Records the status of Key Performance Indicators (KPIs) in assigned systems, with input and oversight from the assigned PL. Assesses and communicates KPIs for associated job tasks to PL with proposed action plan. Prepares and provides status reports to customers with oversight from assigned PL<br>? Ensure all study documents are archived based on the appropriate guidelines and policy. <br>? May serve as project representative for internal and external audits. Provide support for quality assurance activities, including preparation for audits and internal review, preparing documentation and follow through to resolution actionable issues. <br>? May serve as primary customer contact when PL is out of the office. Seeks input from Project Director for customer support.<br>? May mentor and train Project Specialists</p><p><b>Qualifications</b> </p> <p><strong>What we?re looking for</strong><br> ? Bachelor?s Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience<br> ? Moderate relevant clinical research experience with an understanding of clinical drug development and clinical trial operations. Experience in a therapeutic group preferred.<br> ? Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regula- LocationQuébec, QC
- SalaryNot available
- Start date Starts as soon as possible
- vacancies 1 vacancy
- Source Jobillico #13385316
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