As a Clinical Study Manager you are a member of the project team interfacing with R&D, Life Cycle Teams, Clinical Development Teams, Medical Affairs, Regulatory Affairs and Biometrics in the overall design validation planning. Responsible for the timeline and budget planning and execution. Ensures the study types planned meet US/EU requirements for CE and FDA approvals. This role assigns and ensures delivery of specific tasks to/from other members of the Clinical Operations study team including keeping study monitors updated on all relevant clinical trials strategies, strategy changes and all relevant study activities and/or changes. It provides oversight to outside support including CROs, consultants and/or medical advisors.
To be successful in this role, you are a seasoned professional with wide-ranging experience. Managing diverse and often times complex issues, where analysis may require in-depth evaluation of many factors. Exercises judgment in evaluating methods and may determine criteria for obtaining solutions. May coordinate the activities of other employees. Networks with senior internal and external personnel in area of expertise as well as some key contacts outside area of expertise.
Responsible for maintaining and continuously improving the quality system and achieving quality objectives through daily actions.
Key Roles & Responsibilities:
Member of the Project Teams. Acts as the window person to R&D, Program Management (LCTs/IBL), Medical Affairs (DAST), Regulatory Affairs, Biometrics, etc. Has the overall design and conduct responsibilities.
Responsible for the EU/US study management deliverables including the overall timeline and budget. Ensures study types/design planned meet(s) regulatory requirements (ICH/FDA), study endpoints (pre-IDE intended uses) and customer expectations. Ensures study results are continuously validated, assessed, with clear recommendations drawn and communicated.
Prepare Design Validation Plans (DVP), protocols, reports and any publications needed for product launch (EU/US). Assigns specific tasks (roles and responsibilities) to other members of the CT study team including study monitor updates relevant to clinical trial strategies, strategy changes and relevant study activities and/or changes. Reviews and approves site assessments and selection of study sites. Supports local regular and frequent reviews with the CT study team.
Prepares study report including recommendations and corrective actions.
Appoints and oversees investigator(s) or other consultant(s) including outside Medical Advisors, CROs or third party support. Initiates and ensures contacts with international experts and customer groups to use the external know-how for the development of new products and guarantee acceptance of new products.
Train local and external monitors on the study protocol. Reviews cases with monitors to resolve discrepancies. Provides contingency planning for key milestones (monitoring patient enrollment and testing progress) in the projects culminating in the preparation of status reports to project teams and next level management.
Ensures that studies adhere to FDA regulations, Good Clinical Practices and IVD directives.
Transfers study results into scientific publications together with external and internal experts. Presentation of results at workshops, congresses and other printed media according to the requirements of the market and customers.
Bachelor’s 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
CRA certification by a recognized professional organization
1-2 years monitoring experience
2 openings. Employer will assist with relocation costs.
Internal Number: 201901-100727
About Roche Diagnostics
We are the world's number 1 in biotech with 17 biopharmaceuticals on the market. Over half of the compounds in our product pipeline are biopharmaceuticals, enabling us to deliver better-targeted therapies.