Full Job Description
Project Manager (7399U) - 9284 About Berkeley
At the University of California, Berkeley, we are committed to creating a community that fosters equity of experience and opportunity, and ensures that students, faculty, and staff of all backgrounds feel safe, welcome and included. Our culture of openness, freedom and belonging make it a special place for students, faculty and staff.
The University of California, Berkeley, is one of the world's leading institutions of higher education, distinguished by its combination of internationally recognized academic and research excellence; the transformative opportunity it provides to a large and diverse student body; its public mission and commitment to equity and social justice; and its roots in the California experience, animated by such values as innovation, questioning the status quo, and respect for the environment and nature. Since its founding in 1868, Berkeley has fueled a perpetual renaissance, generating unparalleled intellectual, economic and social value in California, the United States and the world.
We are looking for equity-minded applicants who represent the full diversity of California and who demonstrate a sensitivity to and understanding of the diverse academic, socioeconomic, cultural, disability, gender identity, sexual orientation, and ethnic backgrounds present in our community. When you join the team at Berkeley, you can expect to be part of an inclusive, innovative and equity-focused community that approaches higher education as a matter of social justice that requires broad collaboration among faculty, staff, students and community partners. In deciding whether to apply for a position at Berkeley, you are strongly encouraged to consider whether your values align with our Guiding Values and Principles , our Principles of Community , and our Strategic Plan .
Application Review Date
The First Review Date for this job is: August 11, 2020
The Innovative Genomics Institute (IGI) is a non-profit, academic research organization formed through the partnership of UC Berkeley andUC San Francisco located on the UC Berkeley campus. At the IGI, we envision a world in which genome engineering innovations benefit humanity and are accessible to all. A key focus is accelerating translation of CRISPR-based approaches to address real-world problems in human health and agriculture.
The IGI is looking for passionate people who share our vision and values. We are committed to hiring and developing employees who want to work in a high performing culture. The IGI is especially interested in candidates whose previous experience has prepared them to contribute to our commitment to diversity and inclusion. We encourage individuals to apply who may have had non-traditional career paths, taken time off for family/personal reasons, or excelled in careers outside academia.
Diagnostic Site Project Analyst (Internal (within IGI)):
PM stays well integrated with diagnostic and research personnel, and administrative, communications and policy staff to understand the full scope of IGI testing lab activities and strategically develop and advocate for projects about the testing lab operations in the short, medium and long term.
Ensure site work is within capacity estimates.
Leads efforts to conduct highly complex crossdisciplinary analyses, and converts analyses into actionable solutions that optimize quality, maximize productivity, and balance internal and external aspects.
Advocates for solutions, including administering new systems, policies, processes, or programs.
Proposes, leads and / or participates on policy, strategy and planning committees and working groups, including with senior campus leadership.
Serve as a resource for the testing lab on research and development, testing lab quality metrics, and regulatory issues.
Coordinate with policy, scientific, and regulatory personnel to achieve optimal workflow and liaise between the IGI and external partners.
Adapt pre-existing protocols as needed to optimize the quality and timing of the returned specimens.
Diagnostic Site Project Analys (External (with Partner sites)):
Manage relationships with diverse outside clinical partners, navigate complex problems with diplomacy, and proactively monitor and rapidly resolve key operational and administrative issues, internally and externally.
Develops and coordinates policy communications and devises strategies for training and enforcement.
Resolves time-sensitive, delicate or otherwise complex project issues that usually involve representatives from external constituencies.
Makes high level contacts of a sensitive nature, internally and externally, requiring discretion and diplomacy in order to negotiate with or persuade external partners to adopt policy or workflow changes.
Onboard and manage clinical partners.
Regulatory Compliance Analyst:
Develops and advocates for solutions to regulatory issues, including developing and overseeing new quality improvement programs or developing regulatory validation frameworks.
Develops proposals and recommendations to guide and support a broader strategic direction for the regulatory aspects of the testing lab.
Use superior organization and time management skills to improve CLIA compliance.
Collaborate across disciplines, internally and externally, to coordinate the development, implementation and monitoring of new diagnostic programs and processes.
Guides and directs project planning, which may include senior management, faculty, and, as needed, external regulatory bodies.
Generate reports and other regulatory documents, and coordinate submissions to the FDA.
Knowledge of diagnostic regulatory procedures and protocols.
Strong analytical/problem-solving skills.
Strong communication and interpersonal skills to communicate effectively with all levels of staff and influence, both verbally and in writing.
Small to mid-level project management skills.
Ability to multi-task with demanding timeframes.
Ability to use discretion and maintain all confidentiality.
Experience managing complex projects or performing highlevel analyses on program metrics.
Bachelor's degree in molecular biology and/or equivalent experience/training.
Extensive experience in an academic research environment with thorough knowledge of CLIA and FDA diagnostic policies.
Extensive hands-on experience with nucleic acid analytical techniques, including qPCR, to ensure robust ability to assist partners with issues related to CLIA high-complexity diagnostics.
Experience in developing or performing QA/QC on laboratory developed tests.
PhD degree in molecular biology and/or equivalent experience/training strongly preferred.
Salary & Benefits
This is an exempt, monthly paid position. Annual salary is commensurate with experience.
For information on the comprehensive benefits package offered by the University visit: