Global Study Lead (m/f/d)
Posted 3 days 5 hours ago by ITech Consult
Global Study Lead (m/f/d) - clinical project management/Study Management/Clinical Operations/patient and customer-centricity/GSuite/ICH-GCP, IVDD/IVDR, MDR, SaMD, FDA, NMPA/English
Project:
For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified Global Study Lead (m/f/d).
Background:
The Global Study Lead for Investigator Initiated Studies is responsible for ensuring that all studies are evaluated, overseen, closed out and documented in an appropriate manner within the planned timeframe and cost; ensuring compliance to all applicable requirements. Responsible for the budget planning, facilitating review, tracking, and support of studies. Assigns and ensures delivery of specific tasks to/from other members of the study team. Provides oversight to outside support including consultants and/or medical advisors
The perfect candidate: holds a degree and has had their first experiences in the Healthcare Industry. Additionally, the person has more than one year of experience in study management or clinical project management. Lastly, the candidate is fluent in English and knows the role of Clinical Operations in product development.
Tasks & Responsibilities:
* Provides subject matter expertise on specific Clinical Operations activities either directly related to or in support of executing studies and/or enabling projects
* Accountable for activities that contribute to the outcome of one or more studies and/or Clinical Operations enabling projects
* Identifies, contributes to, and participates in continuous improvement and change management activities to solve complex problems and bring new perspectives to existing solutions in support of diagnostics solutions and/or enabling projects
* Independently and with minimal guidance develops plans, creates and manages budgets, and ensures the consistency of studies and/or projects that support studies
* Collaborates across Clinical Operations and other functions to develop and implement best practices across Clinical Operations
* Understands, applies good knowledge of applicable standards and regulations (ICH-GCP, IVDD/IVDR, MDR, SaMD, FDA, NMPA regulations etc) in the review of studies and/or other associated projects
* Drive patient and customer-centricity (mindset, behaviors and actions) by always putting the needs of patients and the customers first
* Partner across diverse regions, cultures, and time zones to create an environment of belonging, inclusion and diversity
* Demonstrate flexibility and adaptability to perform in a fast-paced, matrixed environment where fluid, cross-team collaboration is crucial
* Leverage excellent verbal and written communication skills
* Works closely with Medical Affairs in cross-functional collaboration (eg with Regulatory Affairs, R&D, Clinical Operations teams) to support global strategies and planning of timeline and costs
* Drives process improvements, harmonization and evolution of processes and templates
* Oversees planning and operational aspects of Investigator Initiated Studies and Research Collaborations
* Accountable for study-level budget of assigned studies
Must Havs:
* Minimum of bachelors degree in Life Science and/or relevant expertise in the Healthcare Industry or a related field
* Minimum 1 year of experience in study management or clinical project management
* Conceptual and practical knowledge of Clinical Operations or related areas
* Knowledge of best practices and the role of Clinical Operations in product development; aware of Roche's place in the market and our value proposition to patients and customers
* Solves complex problems; takes a new perspective on existing solutions; exercises judgment based on the analysis of multiple sources of information
* IT affinity for applications such as GSuite
* Fluency in English
Nice to Have:
* Experience or background in multiple disease areas
Reference Nr.: 923840SDA
Role: Global Study Lead (m/f/d)
Industrie: Pharma
Workplace: Rotkreuz
Pensum: 100% (Home Office: max. 3 days a week)
Start: 01.02.2025
Duration: unlimited
Deadline: 01.12.2024
If you are interested in this position, please send us your complete dossier via the link in this advertisement.
About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.