Study Start-Up Manager
Join a Team that Lives to Improve Lives
People come to Genentech from across disciplines and across the world to solve our most challenging medical conditions. You’ll find inspiration in our passion for biotechnology, our purpose to positively impact the lives of millions of patients and our dedication to our people. Joining Genentech means being part of a tradition of inquiry that will change the world. It means embracing our failures as much as our successes. It requires a willingness to look beyond the edge of what's possible. And a focus on doing the day-to-day work that makes great science happen.
The following opportunity exists in our South San Francisco, CA headquarters:
Study Start-Up Manager
Relocation is not designated for this position.
Main Accountabilities and Responsibilities:
- Maximizes the productivity and contribution of the local Study Start-up Team through effective management of team performance, and by developing, coaching and training individual personnel, as needed.
- Oversees the execution of all start-up activities from the time the Study Start-up Specialist (SSUS) is assigned through to site activation, according to agreed project/study strategy, timelines and Roche standards.
- Ensures SSU team members know the applicable regulatory requirements and corresponding related documentation to guarantee adherence and compliance with local regulations.
- Responsible for the ongoing maintenance and analysis of the available study start-up data (metrics) for their country/region and for understanding the local environment (e.g. regulatory, government policies/laws, etc.); drives increased efficiency, reduction in overall start-up timelines and identification of opportunities for continuous improvement.
- Partners with Therapeutic Area Leaders (TALs), Business Support Leads (BSLs), Country Study Managers (CSMs), etc., to ensure understanding of protocol and planned execution strategies; develops a study start-up strategy that meets study/project requirements.
- Partners with TALs to identify key sites/institutions and ensures implementation of relevant strategic partnership arrangements to maximize efficiency, as needed.
- Represents the country and is local SPOC in the SSU network within the regional/global organization, as applicable.
- Accountable for the budget and contract negotiation process, where applicable, and for ensuring adherence to FMV (Fair Market Value); escalates concerns regarding the budget and contract back to the Country Study Manager and/or local FMV Manager for approval, as needed.
- As a member of the local Leadership Team, helps design and supports the local/regional vision and strategy, as applicable.
Who You Are
- University Degree or equivalent, preferably in a medical/science-related field.
- Demonstrated knowledge and understanding of clinical trials and experience in managing projects. Demonstrated knowledge and understanding of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, Good Clinical Practices (ICH-GCP), as well as understanding of the regulatory, ethics and contractual requirements for starting clinical trials in the relevant country. Previous line management experience/supervision of staff is preferred.
- Decision Making — identifies and understands problems and opportunities by gathering, analyzing and interpreting quantitative and qualitative information; choosing the best course of action by establishing clear decision criteria, generating and evaluating alternatives, and making timely decisions; taking action that is consistent with available facts and constraints, and optimizes probable consequences.
- Facilitating Change — encourages others to implement better approaches to address problems and opportunities; leads the implementation and acceptance of change in the workplace.
- Driving for Results — sets high goals for personal and group accomplishment; uses measurement methods to monitor progress toward goals; tenaciously works to meet or exceed goals while deriving satisfaction from that achievement and from continuous improvement.
- Communication -conveys information and ideas clearly and concisely to individuals or groups in an engaging manner that helps them understand and retain the message; listens actively to others.
- Influencing — uses effective involvement and persuasion strategies to gain acceptance of ideas and commitment to actions that support specific work outcomes.
- Building Partnerships — develops and leverages relationships within and across work groups to achieve results.
- Planning & Organizing — establishes an action plan for self and others to complete work efficiently and on time by setting priorities, establishing timelines and leveraging resources.
- Customer Orientation — places a high priority on the internal or external customer’s perspective when making decisions and taking action; implements service practices that meet the customer’s and own organization’s needs.
- Technical/Professional Knowledge and Skills has achieved a satisfactory level of technical, functional and/or professional skill or knowledge in position-related areas; keeps up with current developments and trends in areas of expertise; leverages expert knowledge to accomplish results.
- Business Acumen -uses knowledge of economic, financial, market and industry trends to understand and improve individual, work group and/or organizational results; uses understanding of major business functions, industry trends and own organization’s position to contribute to effective business strategies and/or tactics.
- Availability to travel domestically and internationally if required.
A Job with Benefits Beyond the Benefits
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
At Genentech, we share salary ranges with applicants during the recruiting process, if requested. Third party salary estimates may not be accurate or up-to-date.