Clinical Operations Lead (SE5)
- $89,440 to $110,635 Yearly
Bayside Solutions is seeking a Clinical Operations Lead (SE5) to be part of our client's team in South San Francisco, CA. This is an opportunity to work with a biotechnology company that is determined to use cutting-edge science to identify and develop treatment to patients suffering from serious and life-threatening diseases.
Clinical Operations Lead (SE5)
Contract Length: 1 year
Salary Range: $89,440 - $110,635 per year
Location: South San Francisco, CA
**The company has mandated COVID-19 vaccination for their workforce, effective October 1st, 2021. All external personnel providing services are required to comply with this requirement. **
Summary of Responsibilities:
- Clinical operations - focused on the US, assisting in operational activities from study start-up through database lock: including feasibility, regulatory document management, systems maintenance, site support and vendor management.
- Local and global initiatives and personal development.
- Over time you will flow to other responsibilities according to business needs and your interest
- Review budget site contracts
- Supports the Local Study Team (LST) in developing study specific budgets, ensuring cost alignment across studies and in line with Fair Market Value (FMV), as required.
- Ensures all payments to sites and/or vendors are appropriately approved, within budget and made in a timely manner.
- Supports LST on financial information related to their studies. Provides local teams with guidance on financial decision-making and collaborates in the implementation of global and local initiatives.
- Works collaboratively, efficiently and effectively with internal clients, including Legal, Finance and Procurement, as well with as external parties, providing Clinical Operations budgeting perspective in all discussions.
- Supports the Globally Outsourced Studies Contracting Process (as required by local law) to ensure alignment with insourced budgeting practices and to facilitate the timely approval of site budgets in this study model.
- Ensures compliance with local and group financial rules in PDG Global Operations and maintain SAP Master data.
- Perform payment reconciliation and support audits as needed.
Summary of Qualifications:
- Finance Background
- Basic knowledge of clinical operations or related areas
- Building subject matter expertise on specific clinical operations activities through supporting the execution of clinical trials and/or enabling projects
- Collaborating across departments and other functions to develop and implement best practices across clinical operations.
- Ability to serve as a resource for colleagues; can work across moderate sized projects with manageable risks and resource requirements.
- Always reflects upon and evaluates reasons behind a particular reason or belief and takes responsibility for the implications of personal thoughts or actions.
- Works in rapid cycles (real-time optimization) to prioritize (i.e., determine what work is essential or kill certain things in order to create the capacity to focus on what matters) and ensure the alignments of priorities to the mid- and long-term outcomes.
- Fast adoption, foster changes and being change agents for investigators/patients to adopt new digital technologies in conducting clinical studies.
Bayside SolutionsSouth San Francisco, CA
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