한국로슈 Clinical Operations Lead (B&C) 정규직 채용

Affiliate: Roche Pharma Korea

Cluster: PDG Korea

Work location: Seoul, South Korea

Your key responsibilities 

• Portfolio Delivery is the responsibility and accountability of all members of PDG and is necessary for the success of PDG (Roche). It encompasses how you actively partner and influence stakeholders, and foster collaborative relationships that enable us to drive impactful results. Through your commitment to streamlined processes and effective partnerships, you contribute to Roche's overall success and the advancement of patient care.

• Compliance: all PDG roles are expected to know their respective compliance requirements, including training, as well as execute all work in a compliant manner

• Office presence in line with local guidelines

• Financial Stewardship of our spending and resources

Key accountabilities (but are not limited to)

• Provide and maintain local fee structures and budgetary advice as required 

• Responsible for contract and study budget negotiation with the clinical trial sites during site activation, maintenance, and close-out

• Ensure compliance with Fair Market Value (FMV) principles and local compensation standards in the country

• Support the study budget process for Globally Outsourced Studies

• Act as point of contact to address contract and/or study budget-related questions and timely respond to, interacting with internal stakeholders (legal, study teams, etc.) and external stakeholders (site, CRO, etc.)

• Responsible for developing and updating contract templates for all relevant types of contracts in study management in collaboration with the required departments

• Responsible for archiving all contract documents in accordance with ICH/GCP, legal requirements, FMV guidelines, SOPs, and COREMAP

• Provide feedback to global Finance tools to ensure the process is set up correctly to address the needs of the countries and ensure an efficient process is in place

• Maintains and analyzes budget and contract data (metrics) on assigned studies, ensuring optimal efficiency to reduce budget and contract timelines and identify opportunities for continuous improvement aligned with company priorities.

Who you are

• You believe in the principles of Customer-Centricity, Human-Centricity, Growth Mindset, and Enterprise View.

• You thrive in environments of ambiguity and collaboration where authority is distributed between all of the people involved and where advice seeking is foundational.

• You apply your organizing and problem-solving skills to plan and run efficient operational and enabling aspects of Clinical Operation’s programs, studies, and/or enabling projects.

• You are an effective communicator that shares information transparently and strategically. You are comfortable working out loud and are an active listener. 

• You have established in career with at least 4 years of relevant experience and have working knowledge of Drug Development and Clinical Operations or related areas of expertise.

• Minimum 2 years of experience in Study Start-up including budget & contract related activities will be preferred.