Study Manager - 1 year FTC — Roche
NewCHF 85'500 - 129'500
Roche · Basel (BS)
- Location
- Basel
- Contract
- full-time
- Posted
- Yesterday
SalaryCHF 85'500 - 129'500
Role overview
At Roche you can show up as yourself, embraced for the unique qualities you bring.
Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally.
This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come.
- At Roche you can show up as yourself, embraced for the unique qualities you bring.
- Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally.
- Through your direct study responsibilities you will also contribute to the management of external stakeholder relationships by helping Roche to be the preferred sponsor for sites, patients and other important healthcare providers.
- What you will do / Expectations during your assignment: During your assignment you will participate as a member of the Study Management Team contributing to the delivery and execution of early phase study protocols. You will:
Main responsibilities
- Through your direct study responsibilities you will also contribute to the management of external stakeholder relationships by helping Roche to be the preferred sponsor for sites, patients and other important healthcare providers.
- What you will do / Expectations during your assignment: During your assignment you will participate as a member of the Study Management Team contributing to the delivery and execution of early phase study protocols. You will:
- DELIVER STUDY EXECUTION by providing operational expertise into protocol design and feasibility, country selection, patient centricity and data delivery plans in partnership with cross-functional stakeholders.
- Ensure study quality and integrity by developing and maintaining study systems and documentation (including informed consent forms, communication plan, Trial Monitoring Plan, Trial Master File etc).
- PROVIDE COUNTRY OVERSIGHT, for insourced studies, by supporting or managing feasibility assessments to ensure countries and sites are selected for participation in studies.
- Provide guidance to country operational representatives during studies to ensure countries start-up on time and deliver on their recruitment commitments.
- MANAGE VENDOR PERFORMANCE by providing direction and actively managing relationships.
- Ensure vendors and third-party suppliers deliver against contracted scope of work and performance expectations and adhere to all appropriate standards (including ICH/GCP, SOPs and other regulations).
- PLAN DEMAND AND SUPPLY by overseeing the forecasting and maintenance of supplies (including IMP) needed to ensure sites have the necessary resources to run clinical studies.
- MANAGE RISK AND COMPLIANCE by assisting the study team in the identification, management and mitigation of study-related risks and issues in your areas of responsi
Additional details
- What you will do / Expectations during your assignment: During your assignment you will participate as a member of the Study Management Team contributing to the delivery and execution of early phase study protocols.
