For our international medical partner, Roche Diagnostics Int Ltd based in Rotkreuz, we are looking for a qualified and motivated Study Manager for a long term position.
Tasks
Overall accountability for generation of evidence ensuring that the sponsor responsibilities are fulfilled, while assuring 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
Prepares different scenarios for generation of evidence (e.g. study, RWE)
Proposes evidence generation strategy to the MSA Project Team (in cooperation with the MSA Func.Rep)
Leads the global study team with full accountability for the study with respect to scientific content, quality, cost and timelines. Aligns on roles and responsibilities of team members
Ensures and is responsible that high quality study designs are translated into evaluation plans 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 needed in cooperation with the MSA Func.Rep)
Ensures close cooperation with Regulatory Affairs, Biometrics, DIS and other external functions to support global submission strategies
Develops study design for technical studies in coordination with internal and external experts and the development/project team with full responsibility for study protocol and study report
Provides input to study synopsis prepared by Clinical Science for Clinical Utility and Clinical Performance studies and ensures that these studies are executed based on study synopsis with full responsibility for study protocol and study report
Owns the study budget in cooperation with the Study Team
Accountable for site selection in collaboration with Investigational Site Management
Oversight on COSS support (e.g. contracting, sample acquisition and management, logistics etc.)
Planning and oversight of tasks and work packages for external collaborators in collaboration with the appropriate function
Provides CRO oversight in fully or partially outsourced studies in alignment with the Global Strategic Sourcing Lead
Accountable for data and study result validation, interpretation, drawing of recommendations and communication to Principal Investigators, the MSA Project Team and other teams as needed
Ensures that generated evidence is provided and documented in a timely fashion and ensures that study results are published in collaboration with the Publication Team
Ensure compliance to all relevant Roche safety and QM procedures
Accountable for archiving and audit/inspection readiness
Responsible to bring external know-how in-house for the development of new products and innovative study designs through the scientific interaction with international KOLs, Principal Investigators and end-users
Continuous follow up on market developments and competitor products
Ensures in-depth scientific expertise for cross-functional teams within and outside of MSA in the relevant indication area
Gives input into ClinOps Q documents (process ownership)
Provides mentoring for new hires while onboarding and Study Managers (at all levels) to ensure that their role and contribution is optimized
Must Haves
PhD / PharmD / MD in Life Science and/or relevant disease area expertise(*****)
More than 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 (e.g. coagulation, cardiology)(*****)
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)(*****)
Has special scientific knowledge in a therapeutic or diagnostics / systems area
Statistical knowledge
Professional use of the English language; both written and oral
Demonstrated experience in computer skills
Prepared to travel (National & International)
Nice to Haves
“Can do”-mentality
Learning agility, creativity and ability for development of new concepts
Open, active and clear communicator (written and verbal)
Professional communication style and business behavior in interactions within and outside of Roche, e.g. with customers and KOLs
Ability to manage virtual teams in global studies
Confident and influential approach, ability to provide clear instructions/directions to teams at the same level and at higher levels in a global organisation
Make independent choices and take responsibility for own actions
Understands the needs of others
Conscientious delivery of work in time of adequate quality even when under pressure
Anticipates potential problems, acts quickly/proactively and resolves them effectively
Quickly able to understand and execute new complex tasks
Ability to successfully operate within a multi-cultural and geographically diverse team
Are you interested? Do not hesitate and submit your complete application documents online today.
We value diversity and therefore welcome all applications - regardless of gender, social origin, religion/belief, age or identity.
We also process applications by post, but will not return them for administrative reasons. We look forward to hearing from you!
