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(Senior) Associate Clinical Trial Manager

Employer
Inflammatix, Inc.
Location
Working from Home
Start date
Aug 3, 2022

View more

Discipline
Clinical, Clinical Research, Clinical Trials
Required Education
Associate Degree
Position Type
Contract
Hotbed
Biotech Bay
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Job Details

We are seeking an experienced (Senior) Associate Clinical Trial Manager responsible for vendor and site management while proactively supporting the Study Lead in the conduct of clinical studies.  This role has flexible working arrangements, with the option to work in the office or remotely.


 PRIMARY RESPONSIBILITIES:

  • Assists the Study Lead with drafting and coordinating review of relevant documents including protocols, informed consents, case report forms, and study plans
  • Contributes to the development of RFPs and participates in selection of CROs/vendors
  • Responsible for oversight of one or more study vendors per study vendor oversight plan; including leading vendor meetings, documenting appropriate minutes, tracking action items, setting KPIs and KQIs, as well as identifying and mitigating risks
  • Assists the Study Lead with vendor budgets, including invoice and PO management/reconciliation
  • Participates in the review of data listings and preparation of interim/final clinical study reports
  • Trains CROs, vendors, investigators, and study coordinators on study requirements
  • Oversees study clinical trial site and/or regions; including indirect oversight of CRAs monitoring assigned sites and/or regions in addition to in-house monitoring task, site budget and contract review and approval, tracking start-up, enrollment and close out progress
  • Understands, interprets, and explains protocol requirements to others

MINIMUM QUALIFICATIONS:

  • Associate’s degree (bachelor’s degree preferred)
  • 4+ years relevant experience
  • Thorough knowledge and understanding of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials


KNOWLEDGE, SKILLS & ABILITIES

  • Excellent teamwork, communication, decision-making and organizational skills
  • Must be able to prioritize multiple tasks, ‘wear many hats’ and self-motivated to take on new challenges

COMPENSATION AND CLASSIFICATION:

  • Classification: Full-time
  • Compensation: Competitive and commensurate with experience; includes equity package
  • Benefits: Medical, dental, and vision; 401(k), generous leave and more
  • Location: Bay Area, CA (Remote)


Inflammatix requires all employees to be vaccinated against COVID-19 (subject to any legally protected exemptions).  For travel, Inflammatix requires compliance with all applicable local and national health and safety guidelines.

Inflammatix is an equal opportunity employer and does not discriminate on the basis of race, ancestry, color, religion, sex/gender (including gender identity), pregnancy, childbirth, related medical conditions and breastfeeding, national origin, age, sexual orientation, marital status, registered domestic partner status, military and veteran status, physical or mental disability, medical condition, genetic characteristic, or any other characteristic protected by applicable laws.

Notice to Agencies:

Our internal Talent Acquisition Team manages all career opportunities.   Agencies and independent recruiters must be approved as a vendor by the Legal and Talent Acquisition teams at Inflammatix before submitting candidates (for any current or future positions) to any employee of Inflammatix. We do not accept unsolicited resumes or profiles from agencies or independent recruiters under any circumstances.  Inflammatix will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume or profile.  Please do not contact Inflammatix employees directly. Compliance with this request will impact our decision to engage or work with you or your agency and/or representatives in the future.

 

Company

Inflammatix is developing an innovative point-of-care instrument platform to be used with a rapid (<30-minute) test to aid in the diagnosis of acute infection and sepsis by harnessing the immune system to deliver advanced immune response diagnostics. Our HostDx test rapidly informs the clinician about the likelihood of bacterial or viral infection and the need for ICU level care in the emergency department. Faster results may translate into more timely and appropriate therapy and level of care decisions for better patient outcomes. 

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Find Us
Website
Phone
(650) 443-3030
Location
540 Oakmead Pkwy
Sunnyvale
CA
94085
United States
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