Clinical Trial Manager / Senior Clinical Trial Manager - RWE

Employer
GRAIL, Inc.
Location
Menlo Park, CA, United States
Posted
May 25, 2021
Ref
1987271324
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com.

The Clinical Trial Manager has overall responsibility in supporting Real World Evidence (RWE) and post-marketing studies within Clinical Operations. This will include supporting overall day-to-day execution of a clinical trial, building strong internal and external relationships, managing clinical sites, and collaborating with cross functional teams.

This position will require a candidate to have experience with working in a fast paced environment, ability to work in ambiguity, proactive in seeking and utilizing the resources available to effectively problem solve, ability to be flexible and creative yet ensuring the clinical trial is executed within compliance of regulations and of the highest quality, and to be able to identify areas of improvement to drive efficiency within Clinical Operations.

Duties & Responsibilities:

• Manage all clinical operational aspects of a clinical trial from site selection, start-up, enrollment, maintenance, and close-out
• Prepare and review study related plans and documents including protocols, informed consent forms, recruitment plans, monitoring plans, protocol deviation plans, and case report forms with minimal supervision
• Participate in identifying, selecting, and monitoring the performance of clinical sites
• Ensure proper site training and management, provides ongoing oversight of clinical site compliance with study plans, study protocol, SOPs, FDA regulations, ICH/GCP guidelines, and in accordance with all applicable regulationsParticipates in EDC set-up by contributing to case report form design, user acceptance testing, completion guideline development and other related activities
• Identify any potential risks to the study timelines and/or conduct, propose mitigations and implement mitigations with cross-functional team and manager support
• Monitor clinical data entry progress and follow up on incomplete data entry and/or outstanding queries
• Contribute to the development and management of site budgets and ensure invoice payment according to site payment terms
• Work cross functionally with other departments such as Legal, Data Management, BioSpecimen Management, and Finance on all aspects of the clinical trial
• Provide oversight of regional monitors or contract research organizations (CRO)
• Establish and maintain strong relationships and communication with sites and site staff
• Ensure Trial Master File (TMF) is current and maintained
• Provide guidance and mentorship to CPAs (Clinical Project Assistants)

Minimum Qualifications:

• Bachelor's degree or equivalent in the life sciences or related field required. Additional coursework in clinical trial planning and execution strongly desired
• Ideal candidate will have at least 5 years of relevant experience in managing clinical trials in either sponsor or CRO organizations, with a strong track record of successful trial initiation and execution
• Industry experience within in vitro diagnostics (IVD) highly preferred; pharmaceutical, biologics or medical device experience also acceptable
• Thorough knowledge of GCP, ICH guidelines and other US 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 skillsAble to work effectively under a fast-paced and changing environmentStrong work ethic and demonstrated ability to deliver assignments on timeProficient with office automation tools, such as Microsoft Office and the Google suite of apps

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

GRAIL, Inc. and its affiliates and subsidiaries ("GRAIL") does not accept any liability for fees for resumes from recruiters or employment agencies ("Agency"), without a binding, written recruitment agreement between GRAIL and Agency describing the services and specific job openings ("Agreement"). GRAIL may consider any candidate for whom an Agency has submitted an unsolicited resume and explicitly reserves the right to hire those candidate(s) without any financial obligation to the Agency, unless an Agreement is in place. Any email or verbal contacts with any person within GRAIL is inadequate to create a binding agreement. Agencies without an Agreement are requested not to contact any hiring managers of GRAIL with recruiting inquiries or resumes. Agencies interested in partnering with GRAIL may contact GRAIL's HR Department through our Customer Service team .