In this role you are responsible for effectively managing global studies for validation of diagnostic products in cooperation with external and internal experts, while ensuring compliance to regulatory requirements.
You will work in interdisciplinary teams within the Roche Organization in Europe, US and other locations. Right from the start, you will take responsibility in your projects, providing you with ample opportunity to gain visibility based on your achievements and results.
The team belongs to Clinical Development & Medical Affairs Clinical Operations, Study Management for Roche Diagnostics Solutions (RDS). We work together as a team and collaborate cross-functionally to generate clinical evidence for the organization and our patients while assuring compliance. For us it is very important to maintain respect for differences of opinion, fairness, open communication and consensus building skills. We consider work-life balance as important and off-campus candidates are welcome (if moving to one of the sites is not a possibility).
- Developing study design in coordination with internal/external experts and the development/project team
- Managing the study team with accountability for the study with respect to quality, cost and timelines
- Arranging meetings, preparing and monitoring study plans, data reports, briefing documents, global design validation and recommendation plans in a timely fashion
- Cooperating with Regulatory Affairs to support the pre-submission process
- Planning of the study specific content and budget within the development/project team and controlling the related agreed upon budgets during the study
- Ensuring compliance to all relevant Roche safety and Quality Management procedures in all studies
- Working collaboratively across therapeutic areas with different internal teams and external stakeholders
- Consulting, advising and counseling when appropriate, business customers, Regulatory Affairs, Clinical Operations and across Business units
- Creating and maintaining relationships with international experts and customer groups to support the development and acceptance of new products.
- Maintaining regular communication with key stakeholders to ensure that timely, relevant information is provided and that issues or matters requiring attention are discussed and addressed promptly
- Networking and interfacing with internal colleagues to share information and best practices while remaining actively involved in industry/customer organizations that impact business
Our ideal candidate
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
Study degree in Natural Sciences/Life Science or equivalent education/qualifications in lab diagnostics, or nursing equivalent
- Relevant Expertisein Healthcare Industry or a related field
- Experience or background in multiple disease areas is a plus
- Excellent organizational and communication skills, sense of responsibility, accuracy and urgency and the ability to adjust to new challenges
- Project management skills
- Team player with an interdisciplinary and intercultural sensitivity and work experience
- Superior verbal, written and interpersonal communication skills
- Willingness to travel (30%)
- Creative and innovative thinking ‘out-of-the-box’
- Statistical knowledge
- First leadership experiences in diverse, virtual teams welcome
The position could be located in the following locations of Roche: Mannheim, Indianapolis, Penzberg, Pleasanton, Rotkreuz, Santa Clara, Tucson, Xi’an
To make the application process as convenient as possible for you please add only your updated CV. References and certificates are not required at this stage.
We look forward to receiving your application!
** Preferred candidate identified**