Our Clinical Operations team is growing! Our newest position, the Clinical Trials Manager (CTM), ensures the conduct of all clinical studies in accordance with Good Clinical Practices (GCP) and Veracyte Standard Operating Procedures (SOPs) and assumes the leadership role for one or more clinical studies. Responsibilities include designing, planning, implementing and managing the study/ies. The CTM leads teams that evaluate and verify clinical data and coordinates activities to ensure compliance with the protocol and overall clinical objectives. He/she develops and maintains study budgets, metrics and reporting tools for clinical trials operations. The CTM has broad knowledge of regulations governing the conduct of clinical trials and GCP, strong clinical knowledge, an ability to lead clinical and cross-functional teams, and an ability to translate forecasting and research data. He/she is responsible for managing the full scope of the protocol and study, and participate in development of scientific publications.
Key accountabilities of the role include:
- For all assigned clinical studies, represent Clinical Group in the development and management of overall study and project plan in conjunction with Veracyte cross-functional team; includes managing forecasting matrices, task schedules, timelines and priorities to ensure study plan and progress aligns with business development strategies.
- Solicit input from and collaborate with study Principal and co-investigators and prospective investigators in development of clinical strategies and study/protocol design
- Serve as primary clinical contact for a study including CROs/vendors, Investigators, study coordinators, and administrators
- Coordinate activities for identifying, evaluating, qualifying and selecting CROs or vendors
- Identify, qualify, and select clinical sites and investigators to conduct studies
- Develop clinical study documents, including protocols, informed consent forms, case report forms, site and vendor training manuals, monitoring plans and procedures, and SOPs
- Facilitate submission of protocol and related documents to Independent Review Boards or Ethics Committees
- Manage the initiation, monitoring and coordination of study conduct and completion, including site training, communications, and the conduct of initiation, monitoring and study close-out visits
- Ensure study Trial Master Files (TMFs) are maintained throughout the study period and all processes are conducted according to SOPs
- Review the data management and statistical plans and provide for execution of plan elements
- Assure data quality by planning data review and ongoing process control checks
- Contribute to clinical study report development, review, and finalization
- Develop and maintain effective communication across Veracyte, including the Executive, R&D, Medical Affairs, Regulatory, Finance and Commercial teams; includes regular reporting on adherence to timelines, milestones and budget, with recommendations for plan adjustments as needed
- Effectively communicate changing priorities, within the cross-functional and Clinical teams, as studies progress
- Ensure reporting of adverse events and serious adverse events as required by regulations and SOPs
- Oversee the activities of clinical research staff, both regular and contract staff, including CRAs and CTA’s
Who You Are
You are a self-starter who has impeccable attention to detail and is excellent at working in groups. You've honed your project management skills while leading cross functional teams. Former stakeholders have been impressed by your clear communications and ability to execute. To be a successful candidate, you have 8-10 years of clinical trial experience, preferably in diagnostics or medical devices. We would like you to share our commitment to teamwork and collaboration and be excited by the challenges of applying your expertise to an important, emerging area in diagnostics.
What We Can Offer You
Veracyte is a growing company that offers significant career opportunities if you are curious, driven, patient-oriented and aspire to help us build a great company. We work collaboratively, offering you the opportunity to constantly learn from your colleagues – even those outside of your area of expertise. Here at Veracyte, we find fun, little ways to make it a great place to work – participate in our annual Halloween costume contest, treat yourself to free coffee or the endless supply of PB&J sandwiches, and toast with colleagues as we celebrate milestones. We also offer conveniences such as an on-site workout room and free shuttle service from both BART and CalTrain. We are a company with a heart and believe in positively impacting the world beyond our doors by providing our product to those who cannot afford it through a financial assistance program. Veracyte seeks the best employees and works to create an environment where they can thrive, expand their knowledge and contribute at the highest level.
At Veracyte, we are more than just a diagnostics company. We are redefining diagnostic truth and changing patient care as we know it. We are improving the lives of patients by enabling the evolution of evidence-based clarity from scientific discovery.
Our team embraces challenges - the more complex, the better. We are laser-focused and know how to prioritize. We act with a sense of urgency, because when it comes to advancing patient care, every minute matters. We take ownership of our work and are deeply committed to the success of our team. And, above all, we value integrity - in our work and how we treat all of our stakeholders, including each other.
Our accomplishments and innovation have earned us widespread recognition, from appearing on The Wall Street Journal Next Big Thing list to receiving the 2016 Edison Award, which honors product innovation and excellence. Yet the honor we are proudest of is being named a Top Workplace by the Bay Area News group four years in a row, based solely on feedback from our employees.
Veracyte affords equal employment opportunities to all qualified persons, regardless of race, color, religion, national origin, age, sex, disability, sexual orientation, gender expression, veteran or marital status. Veracyte participates in E-Verify in the United States.