What are the responsibilities and job description for the Clinical Trial Manager position at Exai Bio Inc?
Who We Are
Exai Bio (exai.bio) is an early-stage diagnostic company with a powerful oncRNA and AI-based liquid biopsy platform. Our proprietary technology delivers unprecedented insight into cancer and disease biology from standard, non-invasive blood samples. We are the next generation of liquid biopsy!
Our mission is to deliver the earliest and most accurate diagnosis of cancer. Why? Because we aspire to enable a world where cancer can be detected early, diagnosed accurately, treated in a personalized and targeted way, and ultimately cured.
We know that people are our greatest asset and we are rapidly building a rock-star team of talent. Our people are driven by the mission, inspired by the vision of the future, and are committed to living our core values (integrity, openness, teamwork, exploration, and kindness) that connect us to our work and to one another.
What We are Looking For
A team player who is passionate about improving patient care by leading clinical studies to bring new and innovative tools to healthcare. The ideal candidate would have a thorough understanding of the clinical research process and extensive knowledge of ICH & GCP guidelines and possess excellent communication and leadership skills.
What You’ll Do
Participate in protocol development, CRF design and clinical study report writing
Lead in development and periodic review of standard operating procedures
Guide in the development of important study documents
Conduct feasibility studies
Develop study budgets
Oversee patient recruitment
Ensure compliance of staff with federal and local regulations, GCP and ICH guidelines
Conduct team meetings and staff training programs
Mentor in-house clinical trial staff
Overall responsibility of ongoing studies
Who You Are
A team player who also takes initiative and is able to lead with confidence
Have a thorough understanding of the drug development process with extensive knowledge of ICH-GCP, as well as federal and local regulations
Possess strong written and verbal communication skills
Attentive to details and record keeping
Ability to solve problems and think outside the box
What You Bring to the Team
At least 8 years of experience in the pharmaceutical/biotech industry. Previous experience working in oncology preferred.
Expertise in leading multiple clinical studies in compliance with federal and local regulations and guidelines.
Competent knowledge of Google Workspace and MS Office. Advanced knowledge of MS Excel and electronic data capture systems.
You must be legally authorized to work in the U.S and be fully vaccinated against COVID-19, including all eligible booster(s), with the exception of a medical or religious exemption
What You’ll Get as Part of Our Team
An inspiring working culture where our core values are more than just words on a page. We walk the talk!
Comprehensive Benefits: medical/dental/vision, paid time off, generous holiday schedule, equity and 401k
Additional Benefits: hybrid and remote work options, commuter benefits, home office subsidy and learning & development opportunities
What We Value
Our core values represent what we stand for as a team. This is what we believe in. Everyday, we strive to align our behaviors to these core values in everything we do.
Integrity – Our thoughts and actions are true to science and to people. We do the right thing.
Openness – We recognize and respect our differences – and embrace learning from them.
Teamwork – We are team players who trust and respect each other.
Exploration – We are explorers, putting curiosity into action.
Kindness – We are kind whenever possible – and we believe it’s always possible.
More About Us
Exai Bio was founded with technology from the UCSF laboratory of Dr. Hani Goodarzi, and consists of veteran leaders in the RNA biology, liquid biopsy, and artificial intelligence/machine learning fields from both academia (UCSF, Stanford, MIT) and industry (Bluestar, CareDx, Evidation, Google, 23andMe, Deep Genomics). We are backed by leading life sciences and tech investors, including Section 32, Casdin Capital, and Two Sigma Ventures, who have been integral to advancing cancer diagnostics and artificial intelligence/machine learning technologies in past companies like Foundation Medicine, Thrive Earlier Detection, Insitro and Recursion.
We value a diverse, inclusive workforce and we provide equal employment opportunities for all applicants and employees. All qualified applicants will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws.
We do not accept unsolicited resumes from agencies or other third parties and will not pay fees associated with such resumes. Agencies, please do not send resumes to any of our locations, employees or email addresses.