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About the Role
As Medical Project Manager, you will act as an owner of medical data generation projects, contributing to Bayer’s purpose “Science for a Better Life”. You will combine scientific excellence, operational rigor, and innovative ways of working, while leading projects in line with Bayer’s standard operating procedures (SOPs), all relevant legislation and guidelines.
Responsibilities
- Management of global and governance and management of local non-interventional studies (NIS) / Observational Studies (OS) incl. post authorization and risk management studies required by authorities
- Management of investigator initiated research (IIR) projects
- Management of institution sponsored collaborative studies (ISCS)
- Management of novel study designs, e.g., digital device settings
- Responsible for set up of new NIS & IIR & ISCS
- Provide guidance on feasibility, study concept, and study operations
- Build and lead OS core teams for local NIS
- Coordinate cooperation of local and international as well as internal and external (e.g., CRO) partners for the whole project
- Responsible for adherence to internal (e.g., SOP) and external approval processes and legal requirements including relevant codices
- Management of the production of all study documents and systems
- Planning and controlling of project budgets
- Training of involved parties (e.g., internal staff, physicians, MSLs, Sales Force, CRO)
- Management of analysis, documentation, archiving, and communication of study results
- Adherence to international regulatory requirements and standards (IFPMA, EFPIA, FDA, VFA, FSA, BfArM) incl. trial posting
- Flexible Project Assignments within Digital Innovation, with scope adapting to strategic priorities and organizational needs
Requirements
- Life Science degree (PhD preferred)
- Several years of professional experience and proven track record in pharmaceutical industry and study management
- Experience in planning and managing observational studies and/or investigator-initiated studies
- Excellent interpersonal skills
- Ability to read and interpret clinical study data
- High level of organization, achievement oriented, reliable, able to cope with high workload
- Decision making and problem-solving skills
- Ability to interface at senior level with third parties
- Good understanding of company organization
- Excellent knowledge of relevant software and databases
- Knowledge of relevant legal standards and codices
- Excellent communication skills in German and English
Skills
- Study Management
- Observational Studies
- Investigator-Initiated Studies
- Interpersonal Skills
- Data Interpretation
- Organization
- Achievement Orientation
- Reliability
- Workload Management
- Decision Making
- Problem-Solving
- Senior Level Interfacing
- Company Organization Understanding
- Software and Database Knowledge
- Legal Standards Knowledge
- Codices Knowledge
- Communication Skills (German and English)
Location
- Leverkusen, Germany
Work Type
- Hybrid work models
- Part-time arrangements
Experience Level
- Several years of professional experience
Education Level
- Life Science degree (PhD preferred)
Salary/Compensations
- 88.900€ - 108.000€ per year (full-time) plus a variable component
Benefits
- Flexible, appreciative, and tailored benefits package
- Competitive salary plus a variable component
- Hybrid work models
- Part-time arrangements
- Company daycare centers at multiple locations
- Support in finding childcare
- Time off for the care of elderly or dependent family members
- Summer camps for children
- Access to learning and development opportunities
- Training programs through the Bayer Learning Academy
- Development dialogues
- Coaching and mentoring programs
- Inclusive work environment
About the Company
- At Bayer, we are visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all, Hunger for none' is a reality.
- We are 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’.
- The role is to be filled by Bayer Vital.
Equal Opportunity
- We embrace diversity by providing an inclusive work environment in which you are welcomed, supported, and encouraged to bring your whole self to work.