Senior Clinical Trial Manager # 4398
$131k - $164k6AM City, LLC
Our mission is to detect cancer early, when it can be cured. We are working to change the trajectory of cancer mortality and bring stakeholders together to adopt innovative, safe, and effective technologies that can transform cancer care. We are a healthcare company pioneering new technologies to advance early cancer detection. We have built a multi‑disciplinary organization of scientists, engineers, and physicians and are using the power of next‑generation sequencing (NGS), population‑scale clinical studies, and state‑of‑the‑art computer science and data science to overcome one of medicine's greatest challenges. GRAIL is headquartered in Menlo Park, California, with additional locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and partners in pharmaceutical, technology, and healthcare. Role Overview The Sr. Clinical Trial Manager serves as a clinical operations leader, responsible for guiding the day‑to‑day execution of clinical trials, managing clinical sites, and partnering with cross‑functional teams to ensure operational excellence and timely delivery of study milestones. The role requires experience in a fast‑paced environment, the ability to work in ambiguity, and a proactive approach to problem solving and compliance. Responsibilities Serve as the Clinical Operations Study Lead for assigned studies, providing strategic and operational leadership to ensure successful planning, execution, and delivery. Support and guide Clinical Trial Managers and Clinical Project Assistants to promote best practices and a unified approach to study objectives. Act as the primary point of contact for internal cross‑functional teams. Lead site management and performance oversight, ensuring proper training, strong site relationships, and compliance with study protocols, SOPs, GCP/ICH, and all applicable regulatory requirements. Manage all clinical operational aspects of a trial from site selection and start‑up through enrollment, maintenance, and close‑out. Develop study‑related documents, including informed consent forms, aligning with study objectives, regulatory requirements, and overall strategy. Collaborate on site identification and selection. Participate in EDC set‑up by contributing to case report form design, user acceptance testing, development of completion guidelines, and related activities. Oversee clinical data entry progress, ensuring timely resolution of incomplete data and outstanding queries. Contribute to the development and management of site budgets and ensure accurate invoice payments in accordance with site payment terms. Partner with Clinical Data Management, Biospecimen Management, Finance, Clinical Compliance, Clinical Science, and Lab Operations to define study strategy, align operational plans, and proactively identify and mitigate risks. Provide oversight of regional study monitors and/or contract research organizations to ensure quality, compliance, and timely execution while addressing risk and performance issues. Facilitate external communication with site staff and pharmaceutical partners (as applicable). Ensure the electronic Trial Master File (eTMF) is current and maintained. Required Qualifications Bachelor's degree or equivalent in life sciences or related field. Additional coursework in clinical trial planning and execution is strongly desired. At least five years of relevant experience in managing clinical trials, with a minimum of two years in a Clinical Operations study lead role at a sponsor company (pharma, biotech, or medical device). Industry experience in in‑vitro diagnostics highly preferred; pharmaceutical, biologics, or medical device experience also acceptable. Thorough knowledge of GCP, ICH guidelines, and other U.S. and international clinical regulatory requirements. Working experience with an electronic data capture system, CTMS system, and eTMF system. Strong interpersonal communication (written and verbal), organizational, and prioritization skills. Ability to work effectively under a fast‑paced and changing environment. Strong work ethic and demonstrated ability to deliver assignments on time. Proficiency with office automation tools, such as Microsoft Office and the Google suite of apps. Compensation & Benefits Full‑time, annual base pay for Menlo Park, CA, ranges from $131,000 to $164,000, with adjustments based on skills, experience, and location. Eligible participants may receive an annual bonus plan tied to company and individual performance, an incentive plan, and a long‑term incentive plan. Benefits include flexible time‑off, a 401(k) with company match, medical, dental, and vision insurance, and mindfulness offerings in accordance with applicable plans and policies. Equal Employment Opportunity GRAIL is an equal employment opportunity employer and is committed to building a workplace where every individual can thrive, contribute, and grow. GRAIL policy provides equal employment opportunities without regard to race, color, religion, national origin, sex, gender, sexual orientation, age, marital status, protected veteran status, disability, or any other protected class under applicable law. All phases of employment, including recruiting, hiring, training, promotion, and termination, are governed by this policy. GRAIL maintains a drug‑free workplace. GRAIL will consider all qualified job seekers with criminal histories in a manner consistent with applicable law and provide reasonable accommodations for qualified individuals with disabilities during all phases of the application and interview process. Contact View email address on click.appcast.io if you require an accommodation. For more information about equal employment opportunity protections, please see the 'Know Your Rights' poster. We welcome job seekers from all backgrounds to join us. #J-18808-Ljbffr 6AM City, LLC
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