BioSpace
Senior Clinical Trial Manager #4398
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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.
GRAIL is a healthcare company pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and leverage 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 pharmaceutical, technology, and healthcare companies.
Position Overview The Senior Clinical Trial Manager serves as a clinical operations leader, responsible for guiding the day‑to‑day execution of clinical trials, building and maintaining strong internal and external relationships, managing clinical sites, and partnering with cross‑functional teams to ensure operational excellence and timely delivery of study milestones. The role requires experience working in fast‑paced environments, the ability to work in ambiguity, proactive problem‑solving, and ensuring compliance with regulations and the highest quality standards.
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, ensuring alignment of study activities and a unified approach to achieve study objectives.
Act as the primary point of contact for internal cross‑functional teams.
Lead site management and performance oversight, ensuring proper training, fostering strong site relationships, and monitoring compliance with protocols, SOPs, GCP/ICH, and all applicable regulatory requirements.
Manage all clinical operational aspects of a trial from site selection, start‑up, enrollment, maintenance, and close‑out.
Develop study‑related plans and documents, including informed consent forms, ensuring alignment with study objectives and regulatory requirements.
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 other related activities.
Oversee clinical data entry progress, ensuring timely resolution of incomplete data and outstanding queries.
Contribute to development and management of site budgets and ensure timely and accurate invoice payments.
Partner with cross‑functional stakeholders such as Clinical Data Management, Biospecimen Management, Finance, Clinical Compliance, Clinical Science, and Lab Operations to define study strategy and proactively identify and mitigate risks.
Provide oversight of regional study monitors and/or contract research organizations (CRO) to ensure quality, compliance, and timely execution.
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 a related field.
Additional coursework in clinical trial planning and execution is strongly desired.
At least 5 years of relevant experience in managing clinical trials, with at least 2 years in a Clinical Operations study lead role at a sponsor company.
Industry experience within in vitro diagnostics (IVD) is highly preferred; pharmaceutical, biologics, or medical device experience is also acceptable.
Thorough knowledge of GCP, ICH guidelines and other U.S. and international 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 in a fast‑paced, changing environment.
Strong work ethic and demonstrated ability to deliver assignments on time.
Proficient with office automation tools such as Microsoft Office and the Google suite of apps.
Compensation and Benefits The expected full‑time annual base pay scale for this position is $131,000–$164,000 for Menlo Park, CA. Actual base pay will consider skills, experience, and location.
In addition to base pay, colleagues may be eligible for an annual bonus plan tied to company and individual performance, an incentive plan, and a long‑term incentive plan to align company and colleague success over time.
GRAIL offers a competitive benefit package, including flexible time‑off, a 401(k) with a company match, medical, dental, and vision insurance plans, and selected mindfulness offerings.
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 provides equal employment opportunities without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, marital status, protected veteran status, disability status, medical condition, or any other class protected by applicable federal, state, and local laws.
GRAIL maintains a drug‑free workplace and considers all qualified job seekers with criminal histories in a manner consistent with applicable law. GRAIL provides reasonable accommodations to qualified individuals with disabilities so that they can participate in the job application or interview process.
For more information about equal employment opportunity protections, please view the ‘Know Your Rights’ poster.
We welcome job seekers from all backgrounds to join us!
#J-18808-Ljbffr
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.
GRAIL is a healthcare company pioneering new technologies to advance early cancer detection. We have built a multi-disciplinary organization of scientists, engineers, and physicians and leverage 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 pharmaceutical, technology, and healthcare companies.
Position Overview The Senior Clinical Trial Manager serves as a clinical operations leader, responsible for guiding the day‑to‑day execution of clinical trials, building and maintaining strong internal and external relationships, managing clinical sites, and partnering with cross‑functional teams to ensure operational excellence and timely delivery of study milestones. The role requires experience working in fast‑paced environments, the ability to work in ambiguity, proactive problem‑solving, and ensuring compliance with regulations and the highest quality standards.
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, ensuring alignment of study activities and a unified approach to achieve study objectives.
Act as the primary point of contact for internal cross‑functional teams.
Lead site management and performance oversight, ensuring proper training, fostering strong site relationships, and monitoring compliance with protocols, SOPs, GCP/ICH, and all applicable regulatory requirements.
Manage all clinical operational aspects of a trial from site selection, start‑up, enrollment, maintenance, and close‑out.
Develop study‑related plans and documents, including informed consent forms, ensuring alignment with study objectives and regulatory requirements.
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 other related activities.
Oversee clinical data entry progress, ensuring timely resolution of incomplete data and outstanding queries.
Contribute to development and management of site budgets and ensure timely and accurate invoice payments.
Partner with cross‑functional stakeholders such as Clinical Data Management, Biospecimen Management, Finance, Clinical Compliance, Clinical Science, and Lab Operations to define study strategy and proactively identify and mitigate risks.
Provide oversight of regional study monitors and/or contract research organizations (CRO) to ensure quality, compliance, and timely execution.
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 a related field.
Additional coursework in clinical trial planning and execution is strongly desired.
At least 5 years of relevant experience in managing clinical trials, with at least 2 years in a Clinical Operations study lead role at a sponsor company.
Industry experience within in vitro diagnostics (IVD) is highly preferred; pharmaceutical, biologics, or medical device experience is also acceptable.
Thorough knowledge of GCP, ICH guidelines and other U.S. and international 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 in a fast‑paced, changing environment.
Strong work ethic and demonstrated ability to deliver assignments on time.
Proficient with office automation tools such as Microsoft Office and the Google suite of apps.
Compensation and Benefits The expected full‑time annual base pay scale for this position is $131,000–$164,000 for Menlo Park, CA. Actual base pay will consider skills, experience, and location.
In addition to base pay, colleagues may be eligible for an annual bonus plan tied to company and individual performance, an incentive plan, and a long‑term incentive plan to align company and colleague success over time.
GRAIL offers a competitive benefit package, including flexible time‑off, a 401(k) with a company match, medical, dental, and vision insurance plans, and selected mindfulness offerings.
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 provides equal employment opportunities without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, age, marital status, protected veteran status, disability status, medical condition, or any other class protected by applicable federal, state, and local laws.
GRAIL maintains a drug‑free workplace and considers all qualified job seekers with criminal histories in a manner consistent with applicable law. GRAIL provides reasonable accommodations to qualified individuals with disabilities so that they can participate in the job application or interview process.
For more information about equal employment opportunity protections, please view the ‘Know Your Rights’ poster.
We welcome job seekers from all backgrounds to join us!
#J-18808-Ljbffr