At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining 'impossible'. There are so many reasons to join us. If you're hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there's only one choice. Medical Research Project Manager The Medical Research Project Manager (MR PM) manages and is responsible for all aspects of assigned medical research, namely Observational Studies (OS), Investigator Initiated Research (IIR), and Institution Sponsored Collaborative Studies (ISCS) in accordance with Bayer policies and procedures and applicable regulatory and legal requirements. The MR PM leads the local study teams from study initiation through study close out to ensure successful delivery on study objectives. The MR PM must collaborate internally to present study concepts, obtain alignment with internal stakeholders on study requirements, and promote a sense of urgency to deliver results. The MR PM assumes end to end ownership of the study and builds effective partnerships internally at both the local and global level and externally with Investigators and site staff. The MR PM must be able to anticipate the needs of external customers to mitigate challenges and ensure timely patient recruitment, adherence to country commitments on established timelines, budget and quality requirements. Dependent on the level of experience and skills of the successful incumbent, this role maybe hired as a Medical research project manager or medical research project lead position. Bayer is committed to a flexible hybrid working environment. There are two permanent positions available based out of Mississauga, Ontario. What you will do: Responsible for all aspects of assigned Medical Research, namely Observational Studies (OS), Investigator Initiated Research (IIR), and Institution Sponsored Collaborative Studies (ISCS)Accountable for managing and delivering to the medical affairs research budget for assigned studiesResponsible for audit readiness for local Medical Research studiesMitigate risk by developing action plans and escalate issues for assigned study projects which are tracking behind agreed upon timelines and collaborate with medical affairs for aligned resolution executionProactively contribute to global working groups/projectsParticipate in team and departmental meetings, process improvement projects, quality audits, generation of performance data, and training activities Responsibilities specific to management of IIR and ISCS: Manage IIR, ISCS studies according to local and global Bayer processes, ICH GCP, and Health Canada regulationsOrganize and chair local cross functional study review and approval meetings and facilitate global review processLiaise with local and global colleagues from Medical, Regulatory, Pharmacovigilance, Legal, and Marketing, where appropriateWork with Investigators and Study Coordinators throughout study review process, study start up, recruitment, maintenance, and close outProactively manage study issues and track progress against milestonesReview all study documents proposals, ICFs, protocols, abstracts, posters and manuscripts; distribute to team and collate comments to communicate to siteEnter and track progress of studies in Bayer systems Create and maintain Trial Master File (TMF)Assess budget for Fair Market Value and negotiate, forecast, and track budgetWork collaboratively with legal to draft and negotiate contracts with investigators and institutionsResponsible for the set up of studies in financial systems and issue study paymentsProactively update team members on status of studiesManage provision of product supply (clinical and commercial) to sitesEnsure that site is compliant with serious adverse event (SAE) and other safety information reporting obligations to Bayer Responsibilities specific to management of Observational Studies: Manage all OS study related activities from country confirmation through to study report completion to ensure that study execution is on track and follows Bayer processes and applicable regulatory requirementsWork closely with Study Coordinators and Investigators throughout studyConduct study feasibility with input from the Therapy Area specialistsDevelop country and site specific budgets, provide monthly accruals, initiate and track payments, and provide budget forecastAdapt global study documents for use in Canada, where necessaryReview, collect, and track completed documents from sites and create and maintain TMFWork collaboratively with legal to draft and negotiate contracts with investigators and institutionsConduct site training and initiation visitsTrack and proactively manage patient recruitment, query resolution, and study close out activities at the sitesParticipate in global study meetings and update global databasesProvide monthly updates to local team on study statusFor locally initiated OS studies, take on the role of study manager and conduct activities at study level in addition to country and site activities above Who you are: Minimum Bachelor of Science or higher science degree (MSc or equivalent preferred)Minimum of 3 years of relevant project management experience or clinical research experience or formal project management training (example, Project Management Professional certification)In depth working knowledge of drug development process, study management, ICH GCP, drug safety requirements, regulatory requirements, and applicable privacy laws.Ability to build and maintain strong relationships internally and with external stakeholders and strong interpersonal skillsStrong budget management skillsEffective written and verbal English communication skills and strong oral presentation skillsStrong negotiation and strategic, critical thinking abilities and proactive mindsetKnowledge of research contract requirementsStrong leadership, decision making and issue resolution skills; ability to effectively lead and manage matrix team to alignmulti discipline functions to overall goalsExceptional organizational, project management and time management skills with attention to detail and excellent follow throughStrong self motivation skills and ability to effectively manage competing priorities with minimal supervisionWhat we offer: Competitive compensation and rewards packageCollaborative, diverse and inclusive cultureCareer development and global opportunitiesWork-life flexibility programs such as flex hours, employee discounts, volunteer days, wellness, and other employee offeringsBayer is committed to fostering, cultivating and preserving a culture of Inclusion and Diversity. We embrace and encourage our employees' differences and believe that our people are our most valuable asset. The collective sum of individual life experiences, knowledge, innovation, self-expression, unique capabilities that our employees invest in their work represents our culture, reputation, and Bayer's values and purpose. Application deadline: September 4, 2024 #LI-CA Bayerwelcomes and encourages applications from people with disabilities. Candidates participating in ourselection process requiring accommodation due to adisability or medical need are encouraged to notify the Bayer representative that they will be meeting with to ensure appropriate arrangements can bemade. Location: Canada : Ontario : Mississauga Division: Pharmaceuticals Reference Code: 824936
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