Job Title

Description Directeur/Directrice mdical(e), premires phases - Poste bas dans la ville de Qubec Syneos Health est une organisation de pointe en matire de solutions biopharmaceutiques entirement intgres, conues pour acclrer la russite des clients. Nous traduisons des perspectives cliniques, daffaires mdicales et commerciales uniques en rsultats qui rpondent aux ralits du march actuel. 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. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll 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. Discover what our 29,000 employees, across 110 countries already know: TRAVAILLER ICI FAIT UNE DIFFRENCE PARTOUT 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 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. We are continuously building the company we all want to work for and our customers want to work with. Pourquoi? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - were able to create a place where everyone feels like they belong. Job Responsibilities Venez dcouvrir ce que nos 25 000 employs savent dj : le travail accompli ici a des rpercussions partout. Nous sommes un chef de file de lindustrie biopharmaceutique en constante volution, ce qui signifie que vous aurez dinnombrables occasions de travailler avec des experts du monde entier et vous obtiendrez la carrire dont vous avez toujours rv. En tant que membre de lquipe Syneos Health, vous participerez lobtention de rsultats dans un objectif plus que valorisant : amliorer la vie de patients partout dans le monde. Pour nous, un patient nest pas un numro, ils sont notre famille, nos amis et nos voisins. #SyneosHealthLife reprsente notre engagement envers notre culture du soi total, au sein de laquelle tous et chacun peut tre authentiques. Notre culture du soi total est notre fondement global; nous reconnaissons que la contribution unique de chaque personne fait toute la diffrence. Nous croyons que notre russite provient directement des personnes qui linitient, vous! Nous apprcions votre engagement envers nos clients et nos patients, nous voulons donc nous engager envers vous en vous offrant un programme davantages sociaux complet comprenant une couverture pour tous les aspects mdicaux, physiques, psychologiques et financiers. Nous travaillons sans relche btir lentreprise pour laquelle nous rvons tous de travailler et avec laquelle nos clients veulent travailler. Pourquoi? Parce que lorsque nous regroupons diverses opinions, expriences, cultures et perspectives, nous sommes en mesure de crer un endroit o chacun se sent sa place. RESPONSABILITS DU POSTE En collaboration avec lquipe mdicale et de scurit clinique, a ssurer en tout temps la scurit des participants pendant ltude clinique ainsi quaprs la fin de ltude, conformment au protocole et aux rgles de Bonnes pratiques cliniques (GCP). Planifier et raliser lensemble des activits mdicales lies ladmissibilit des participants (examen mdical, rsultats de laboratoire, interprtation dlectrocardiogrammes, etc.) afin de garantir le respect des critres dinclusion et dexclusion. valuer les e ffets indsirables et porter les jugements mdicaux appropris; complter les rapports requis pour les effets indsirables srieux . Examiner les protocoles et les formulaires de consentement clair afin de garantir la scurit des participants et lintgrit des donnes. Sassurer que lquipe mdicale est qualifie, forme et dment dlgue pour les sances de slection et pour ltude. Planifier, organiser, grer et suivre les activits mdicales lUnit de recherche clinique de Qubec selon les besoins oprationnels de lorganisation. Identifier, communiquer et mettre en uvre des activits visant lamlioration du travail. Superviser, encadrer et agir comme mentor auprs de lquipe mdicale et du personnel clinique. Peut se voir attribuer dautres tches cliniques. EXIGENCES DU POSTE Doctorat en mdecine . Membre actif du Collge des mdecins du Qubec. Matrise du franais; bonne comprhension de langlais. De cinq huit ans dexprience en pratique mdicale; exprience en recherche clinique considre comme un atout. Excellentes habilets de communication, de prsentation et de relations interpersonnelles, tant loral qu lcrit, avec une capacit informer, influencer, convaincre et persuader. Connaissance des lignes directrices GCP/ICH ainsi que dautres exigences rglementaires pertinentes (atout). Comprhension et connaissance de lindustrie pharmaceutique et des organisations de recherche sous contrat en gnral, ainsi que du milieu clinique. Leadership dmontr et fortes aptitudes pour la rflexion tactique et stratgique. Avertissement : La liste des activits, des tches et des responsabilits prsente dans cette description de poste nest pas exhaustive. LEntreprise, sa seule discrtion et sans pravis, pourrait attribuer dautres activits, tches ou responsabilits au poste. Des expriences, des comptences et/ou des tudes quivalentes seront galement prises en compte; les qualifications du titulaire de ce poste pourraient donc tre diffrentes de celles numres dans la description de poste. LEntreprise, sa seule discrtion, tablira ce qui constitue un quivalent aux qualifications dcrites prcdemment. De plus, rien dans la prsente ne doit tre interprt comme crant un contrat de travail. Occasionnellement, les comptences/expriences ncessaires pour un travail sont exprimes en termes brefs. Tout langage contenu dans la prsente vise satisfaire pleinement toutes les obligations imposes par la lgislation de chaque pays dans lequel lEntreprise exerce ses activits, y compris la mise en application du document EU Equality Directive , relativement au recrutement et au travail de ses employs. LEntreprise sengage respecter la loi Americans with Disabilities Act , y compris la disposition sur les accommodements raisonnables, sil y a lieu, afin daider les employs ou les candidats effectuer les tches principales de leur poste. 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, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. 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 JOB SUMMARY In collaboration with the management team, the medical director oversees all medical services occurring at our Quebec City Clinical Research Unit. In addition, being also a Clinical Investigator, he/she is responsible for all medical activities related to clinical trials, data integrity, and safety of participants. JOB RESPONSIBILITIES Along with the medical and safety team, ensure subject safety at all times during the clinical study and after the study has been completed as required by the protocol and Good Clinical Practice regulations. Plan and carry out the full spectrum of medical activities related to subject eligibility for studies (e.g., medical exam, laboratory results, electrocardiogram assessment, etc) so that inclusion and exclusion criteria are adhered to. Assess adverse events and make an appropriate medical judgement; complete reports for serious adverse events as required. Review protocols and informed consent forms to ensure participant safety and data integrity Ensure that the medical team is qualified, trained, and delegated for screening sessions and for the study. Plan, organize, manage, and monitor medical activities at the Quebec City Clinical Research Unit according to the operational needs of the organization. Identify, communicate, and proceed with work-improving activities Supervise, coach, and mentor medical team and clinical staff May be assigned other clinical tasks QUALIFICATION REQUIREMENTS (please indicate if preferred) Doctorate in medicine Active membership of the Collge des Mdecins du Qubec Fluency in French, Proficiency in English Five to 8 years of medical practice, and experience in clinical research considered an asset Excellent communication, presentation, people skills, both written and spoken, with an ability to inform, influence, convince, and persuade. Knowledge of GCP/ICH guidelines and other applicable regulatory requirement considered an asset. Understanding and knowledge of the pharmaceutical industry and contract research organizations in general, and the clinical community specifically. Demonstrated strong leadership, tactical and strategic thinking skills.