Medical Research Project Manager

**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 the successful delivery of 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.

Bayer is committed to a flexible hybrid working environment. This is a permanent position.

**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 the medical affairs research budget for assigned studies.
- Support audit readiness for local Medical Research studies
- Mitigate 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 execution.
- Proactively contribute to global working groups/projects.
- Participate in team and departmental meetings, process improvement projects, quality audits, generation of performance data, and training activities.
- Manage IIR, ISCS studies according to local and global Bayer processes, ICH GCP, and Health Canada regulations.
- Organize and chair local cross-functional study review and approval meetings and facilitate the global review process.
- Liaise with local and global colleagues from Medical, Regulatory, Pharmacovigilance, Legal, and Marketing, where appropriate.
- Work with Investigators and Study Coordinators throughout the study review process, study start-up, recruitment, maintenance, and close-out.
- Proactively manage study issues and track progress against milestones.
- Review all study documents - proposals, ICFs, protocols, abstracts, posters, and manuscripts; distribute to the team and collate comments to communicate to the site.
- Enter and track the progress of studies in Bayer systems.
- Create and maintain Trial Master File (TMF).
- Assess budget for Fair Market Value and negotiate, forecast, and track budget.
- Work collaboratively with legal to draft and negotiate contracts with investigators and institutions.
- Responsible for the set-up of studies in financial systems and issue of study payments.
- Proactively update team members on the status of studies.
- Manage the provision of product supply (clinical and commercial) to sites.
- Ensure that site is compliant with serious adverse events (SAE) and other safety information reporting obligations to Bayer.
- 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 requirements.
- Work closely with Study Coordinators and Investigators throughout the study.
- Conduct study feasibility with input from the Therapy Area specialists.
- Develop country and site-specific budgets, provide monthly accruals, initiate, and track payments, and provide a budget forecast.
- Adapt global study documents for use in Canada, where necessary.
- Review, collect, and track completed documents from sites and create and maintain TMF.
- Work collaboratively with legal to draft and negotiate contracts with investigators and institutions.
- Conduct site training and initiation visits.
- Track and proactively manage patient recruitment, query resolution, and study close-out activities at the sites.
- Participate in global study meetings and update global databases.
- Provide monthly