Job Description

This website uses cookies to ensure you get the best experience on our website.TFS HealthScience and selected partners use cookies and similar technologies to ensure you get the best experience on this website. If you consent to it, we will use cookies for analytics purposes.See our to read more about the cookies we set.You can withdraw and manage your consent at any time, by clicking "Manage cookies" at the bottom of each website page.common--cookies--alert#acceptAll">Accept all cookies common--cookies--alert#disableAll">Disable non-necessary cookies common--cookies--alert#openPreferences">Cookie preferences common--cookies--preferences#open" class="bg-company-primary text-company-primary shadow-form inset-x-4 mb-4 rounded max-w-screen-sm p-4 overflow-auto max-h-[80vh] z-cookie-alert backdrop:bg-[rgba(0,0,0,0.6)] sm:p-10 sm:mb-auto sticky top-2">Select which cookies you acceptOn this site, we always set cookies that are strictly necessary, meaning they are necessary for the site to function properly.If you consent to it, we will also set other types of cookies. You can provide or withdraw your consent to the different types of cookies using the toggles below. You can change or withdraw your consent at any time, by clicking the link \xe2\x80\x9cManage Cookies\xe2\x80\x9d, that is always available at the bottom of the site.To learn more about what the different types of cookies do, how your data is used when they are set etc, see our .Strictly necessaryThese cookies are necessary to make the site work properly, and are always set when you visit the site. Vendors Teamtailorcommon--cookies--preferences#handleCategoryToggle">AnalyticsThese cookies collect information to help us understand how the site is being used. Vendors Teamtailorcommon--cookies--preferences#handleAccept">Accept these cookies common--cookies--preferences#handleDecline">Decline non-necessary cookiescommon--header--menu#toggle" data-common--header--menu-target="button" title="Career menu" > Career menuEmployee Candidate Homepagecommon--dropdown#toggle">common--share#handleClick" data-provider="Facebook"> Facebook common--share#handleClick" data-provider="Twitter"> X common--share#handleClick" data-provider="LinkedIn"> LinkedInProject Management \xc2\xb7 Ottawa \xc2\xb7 HybridGlobal Study Directorcareersite--jobs--form-overlay#showFormOverlay" data-careersite--jobs--form-overlay-target="coverButton"> ApplyJoin Our Team as a Global Study DirectorTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.About this roleThe Global Study Director (GSD) is a business-critical role within Study Management,
whose main accountability is the operational planning and delivery of high priority and complex clinical studies or multiple studies within or across program(s).As part of our SRS team you will be dedicated to one sponsor, a global patient-focused pharmaceutical companyKey Responsibilities:

• Accountable from set-up through maintenance, close-out and study archiving for the operational planning, leadership and delivery of multiple studies or overseeing (either within an asset or across assets) single, complex/novel studies (such as platform, basket, etc.) to time, cost, and quality.
• Contributes expert clinical operational input into project strategy and study design/or documents (e.g. Protocol Concept Sheet).
• May contribute to operational interactions with external entities including regulatory agencies, preferred partners/suppliers and external collaborators
• May perform Study Management department leadership tasks as delegated by the Senior Director Study Management
• Lead, provide guidance and delegate appropriately to a cross-functional study team or oversee outsourced delivery activities to ensure the clinical study progresses as planned, driving achievement of milestones according to timelines, budget, and quality standards. May hold accountability and/or oversight of several studies.
• Lead and facilitate communication across all functions. Collaborate with other functions to establish strategies and identify synergies aimed at increasing efficiency of global study teams.

Qualifications:

• University degree (or equivalent educational/work experience), preferably in

medical or biological sciences or discipline associated with clinical research * Minimum of 7 years progressive experience in clinical research, with at least 5 years of clinical development project management experience (or equivalent)

• Extensive knowledge of ICH-GCP, relevant regulatory/ethics requirements and clinical/drug development and demonstrated abilities in clinical study management processes and clinical/drug development
• Thorough understanding of cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs
• Extensive and proven experience project management and in driving operational delivery to timelines, cost and quality

What We OfferWe provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You\'ll be joining a team that values collaboration, innovation, and making a difference in the lives of patientsA Bit More About UsOur journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.Department Project Management Role Director Project Management Locations Ottawa Remote status Hybrid Employment type Full-time REQ ID 225703 Work Arragement HybridOttawacareersite--jobs--form-overlay#showFormOverlay">Apply jobs--overlay#closeOverlay">Project Management \xc2\xb7 Ottawa \xc2\xb7 HybridGlobal Study DirectorLoading application formCareer site

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