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发帖数: 295 | 1 有兴趣的话发简历至hzheng At guardanthealth.com
ABOUT THE ROLE
As Senior Clinical Trial Manager (Sr. CTM), you’ll be responsible for the
successful design and day-to-day execution of clinical trials from the
protocol concept through publication. You ensure completion of study
deliverables, typically work on studies that are either internally driven or
investigator initiated, proactively identify and resolve clinical project
issues and participate in process improvement initiatives. You’ll engage
with study investigators, vendors and external stakeholders.
In addition, you will:
Assist in the process of protocol finalization and manage all aspects of
study execution. Use operational and therapeutics expertise to optimize
trial design and execution.
Manage operational plans and timelines to achieve on-time enrollment and
study completion. Identify barriers to timely and successful study execution
and proposes solutions to same, with regular reporting of study performance
metrics.
Manage Contract Research Organization (CRO) relationships and contracts for
study execution where applicable.
Assist with management and/or execution of site training and ongoing
educational interventions to assure compliance with study protocols.
Assure compliance with all regulatory requirements.
Drive data collection, clinical trial database construction, and assist with
necessary audits of data to ensure data validity.
May have direct reports such as CTAs and/or CTMs.
ABOUT YOU
You are a seasoned clinical operations professional with a proactive mindset
and an ability to find great solutions to complex problems cross
functionally. You have had experience in the oncology space in
pharmaceutical or biotech development, and we see clinical experience,
cancer center, inpatient/outpatient or physician office experience as a plus
. You work to maintain your therapeutic knowledge. You have solid
organizational and business assessment skills and over time, you’ve
demonstrated an ability to develop productive working relationships across
functions and with external partners/teams. You work very well with minimal
direction and seek out answers or collaboration where you need them.
You have excellent written and verbal communication skills. You’re known
to have a strong problem solving ability and a flexible and solution-seeking
attitude.
In addition, you have:
Bachelor’s degree (or higher) in science or health-related discipline
7+ years of clinical trial experience in Pharmaceutical, Biotech or CRO
company. 3+ years direct trial management experience, preferably including
clinical team management.
Strong understanding of GCPs, ICH, and knowledge of regulatory requirements
Ability and willingness to travel 25%-50% of the time.
Must have excellent knowledge of MS Office, project management and clinical
trials software
ABOUT OUR COMPANY
Guardant Health develops breakthrough diagnostic technologies to improve
cancer management. With Guardant360, we offer real-time, biopsy-free tumor
sequencing that tracks tumor genomics in real-time and identifies associated
treatment options. The recent introduction of groundbreaking analytical
tools, including our Tumor Response Map and a mobile-enabled physician
portal, further advance Guardant Health's momentum.
Guardant Health has raised almost $200M from OrbiMed, Sequoia Capital,
Khosla Ventures, Lightspeed Venture Partners, and Formation8, and is led by
a seasoned management team of thought leaders and successful serial
entrepreneurs in next generation sequencing and rare cell diagnostics. They
are advised by an oncologist-led medical steering committee from leading
cancer centers. |
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