Clinical Trial Manager #4356

Grail • Menlo Park, CA

176d • $117,000 - $138,000

About The Position

The Clinical Trial Manager has overall responsibility to support 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.

Requirements

• Bachelor's degree or equivalent in the life sciences or related field required
• At least 5+ years of relevant experience in managing clinical trials at a sponsor company (pharma, biotech, or medical device) with a strong track record of successful trial initiation and execution
• 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 skills
• Able to work effectively under a fast-paced and 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

Nice To Haves

• Additional coursework in clinical trial planning and execution is strongly desired
• Industry experience within in vitro diagnostics (IVD) highly preferred; pharmaceutical, biologics or medical device experience also acceptable
• Experience working on Investigational Device Exemption (IDE) and Real World Evidence (RWE) studies (highly preferred)

Responsibilities

• Manages all clinical operational aspects of a clinical trial from site selection, start-up, enrollment, maintenance, and close-out
• Prepares and reviews study related plans and documents including protocols, informed consent forms, recruitment plans, monitoring plans, protocol deviation plans, and case report forms with minimal supervision
• Participates in identifying, selecting, and monitoring the performance of clinical sites
• Ensures 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 regulations
• Participates in EDC set-up by contributing to case report form design, user acceptance testing, completion guideline development and other related activities
• Identifies any potential risks to the study timelines and/or conduct, proposes mitigations and implements mitigations with cross-functional team and manager support
• Monitors clinical data entry progress and follows up on incomplete data entry and/or outstanding queries
• Contributes to the development and management of site budgets and ensures invoice payment according to site payment terms
• Works cross functionally with other departments such as Legal, Clinical Data Management, Biospecimen Management, Finance, Clinical Compliance, Clinical Development, and Lab Operations on all aspects of the clinical trial
• Provides oversight of regional study monitors and/or contract research organizations (CRO)
• Facilitates external communication with site staff and pharmaceutical partners (as applicable)
• Ensures Trial Master File (TMF) is current and maintained
• Provides guidance and mentorship to CPAs (Clinical Project Assistants)

Benefits

• Flexible time-off
• 401k with a company match
• Medical, dental, vision plans
• Mindfulness offerings
• Annual bonus plan tied to company and individual performance
• Long-term incentive plan to align company and colleague success over time

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree