Medical Research Project Manager

hace 4 días

Barcelona, Barcelona, España Bayer (Schweiz) Ag A tiempo completo
About the Role

Bayer (Schweiz) Ag is seeking a highly skilled and experienced Medical Research Project Manager to join our team. As a Medical Research Project Manager, you will be responsible for managing and delivering medical research projects, ensuring that they are executed in accordance with Bayer's policies and procedures, as well as applicable regulatory and legal requirements.

Key Responsibilities
  • Manage and deliver medical research projects, including 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 studies
  • Responsible for 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
Responsibilities Specific to Management of IIR and ISCS
  • 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 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 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 team and collate comments to communicate to site
  • Enter 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 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 study payments
  • Proactively update team members on status of studies
  • Manage provision of product supply (clinical and commercial) to sites
  • Ensure 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 requirements
  • Work closely with Study Coordinators and Investigators throughout 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 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 updates to local team on study status
  • For 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
Requirements
  • 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 skills
  • Strong budget management skills
  • Effective written and verbal English communication skills and strong oral presentation skills
  • Strong negotiation and strategic, critical thinking abilities and proactive mindset
  • Knowledge of research contract requirements
  • Strong leadership, decision-making, and issue resolution skills; ability to effectively lead and manage matrix team to align multi-discipline functions to overall goals
  • Exceptional organizational, project management, and time management skills with attention to detail and excellent follow-through
  • Strong self-motivation skills and ability to effectively manage competing priorities with minimal supervision
About Bayer (Schweiz) Ag

Bayer (Schweiz) Ag is a leading life science company that is committed to fostering, cultivating, and preserving a culture of inclusion and diversity. We believe that our people are our most valuable asset, and we are dedicated to providing a collaborative, diverse, and inclusive work environment that allows our employees to grow and thrive.

We offer a competitive compensation and rewards package, as well as opportunities for career development and global growth. We are committed to work-life flexibility and provide programs such as flex hours, employee discounts, volunteer days, wellness, and other employee offerings.

We are an equal opportunities employer and welcome applications from people with disabilities. Candidates participating in our selection process requiring accommodation due to a disability or medical need are encouraged to notify the Bayer representative that they will be meeting with to ensure appropriate arrangements can be made.

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