Member of the project team interfacing with R&D, Life Cycle Teams, Clinical Development Teams, Clinical Science, Medical Affairs, Regulatory Affairs, Biostatstics/Data Management and DIS, participating in the overall design validation planning. Holds overall accountability for generation of evidence ensuring that the sponsor responsibilities are fulfilled, as well as ensuring compliance to all applicable regulatory requirements (e.g. FDA, IVDR). Ensures in-depth scientific expertise for cross-functional teams within and outside of MSA in the relevant indication area. Responsible for the timeline and budget planning and execution of studies. Ensures the study types planned meet US/EU requirements for FDA and CE approvals. Assigns and ensures delivery of specific tasks to/from other members of the Clinical Operations study team. Keeps the study team updated on all relevant clinical trial strategies, strategy changes and all relevant study activities and/or changes. Provides oversight to outside support including CROs, consultants and/or medical advisors. Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.
Duties & Responsibilities
- Prepares scenarios for generation of evidence (e.g. study, RWE, etc.). Proposes evidence generation strategy to the MSA Project Team (in cooperation with the MSA Func.Rep).
- Ensures and is responsible that evaluation plans are available for design validations/performance evaluations and clinical studies pre-DCC, during DCC and post-launch and that these are developed in cooperation with internal and external experts. Ensures close collaboration with MSA Functional Representatives in the MSA Project Team to support planning of timeline and cost as well as close cooperation with Regulatory Affairs, Biostatistics/DM and DIS to support global submission strategies.
- Develops the study design for technical studies in coordination with internal/external experts and with the development/project team. Provides input to the study synopsis prepared by Clinical Science for Clinical Utility and Clinical Performance studies and ensures that these studies are executed based on the study synopsis. Holds full responsibility for study protocols and study reports.
- Responsible for scientific interaction with international KOLs, Principal Investigators and end-users to bring external know-how in-house for the development of new products and innovative study designs. Ensures in-depth scientific expertise for cross-functional teams within and outside of MSA in the relevant indication areas. Provides mentoring for new hires.
- Leads the global study team with full accountability for the study with respect to scientific content, quality, cost and timelines. Assigns roles and responsibilities of team members. Accountable for site selection in collaboration with Investigation Site Management. Provides CRO oversight in fully or partially outsourced studies in interaction with the Global Strategic Sourcing Lead.
- Accountable for data and study result validation, interpretation, drawing of recommendations and communication to the MSA Project Team, Principal Investigators, and other teams as needed. Ensures that study results are published in collaboration with the Publication Team
- Accountable for compliance to all relevant Roche safety and QM procedures.
- Bachelors degree in medical technology, chemistry, biology or other life sciences
- Knowledge of applicable standards and regulations for clinical trial and lab conduct
- Proven oral and written communications skills
- Proven planning, organizing, interpersonal and leadership skills
- Ability to work independently to make sound decisions and analyze and solve problems
- Demonstrated experience in computer skills to include Microsoft Word, Excel and basic templates
- Statistical knowledge
- Master’s / PhD / PharmD / MD in Life Science and/or relevant disease area expertise
- 3+ years of experience in IVD (preferred) or Medical Device Study Management in all stages of international clinical trials, study protocol design, report writing and leading matrix teams
- Experienced in biochemical, chemical or biophysical area with detailed knowledge in specific fields of diagnostics especially in the indication of cardiology, if possible combined with a clinical background.
- Knowledge of applicable standards and regulations for clinical trials and lab conduct (International Conference on Harmonization / WHO Good Clinical Practice standards (ICH-GCP), IVDD/IVDR, FDA regulations)
- Project Management knowledge
- Statistical knowledge