Clinical Trial Manager
Scientific Search3.6
Remote Palo Alto, CA
Job details
Estimated: $72,000 - $97,000 a year
Job description

Clinical Trial Manager

Location: West Coast (Remote plus travel)

Therapeutic Area: Oncology Cell Therapy


Our growing next generation cell therapy company has tasked Scientific Search in finding them a Clinical Trial Manager who will report into the Head of Clinical Operations. Our client has significant buzz surrounding them, a fantastic culture, and a late stage asset that is heading towards Phase III.


Responsibilities:

  • Provide study-specific training and leadership to clinical research staff.
  • Assist with monitoring overall CRO and vendor performance and study progress as it relates to timelines, budgets, quality, and compliance with relevant regulations and guidelines.
  • Work with the study team to design clinical protocol; provide input for the design of the ICF template, source documents and CRFs.
  • Prepare and/or review study-related documents to include clinical logs, forms, manuals, and guidelines.
  • Oversee the management of study monitoring visits, and the review and approval of monitoring reports.
  • Mentor and develop in-house CRA team
  • Oversee the collection, review and filing of site essential documents, and maintenance of the TMF.
  • Participate/present at CRO, vendor and Investigator Site meetings as necessary
  • Assist in onboarding and training clinical research associates.
  • Assist with development and management of clinical budgets and contracts

Requirements:

  • BA/BS or equivalent with a minimum of 5 years of relevant clinical trial management experience
  • Therapeutic experience in oncology/hematology and cell and gene therapy preferred
  • Strong working knowledge of FDA and ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures.
  • Experience with Trial Master File management according to the DIA reference model
  • Experience operating within various site EMR/EHR systems
  • Experience using eTMF, EDC (IBM experience ideal), CTMS, and other vendors systems/portals

For immediate consideration please email Jelena Kocovic, at Jelena@Scientificsearch.com

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Employee

2 to 10

Revenue

$5M to $25M (USD)

Company ratings
  • Overall
    3.6
  • Company & Benefits
    4.0 / 5
  • Culture & Values
    3.3 / 5
  • Career Opportunities
    4.0 / 5
  • Work/Life Balance
    4.0 / 5
  • Senior Management
    3.6 / 5
Company reviews
"Decent entry level experience"
Former EmployeeTechnical Recruiter
Most of the middle management team have a "bully" type of personality, so if you aren't willing to join in and take some low blows, and mix in a little racism and ageism, this might not be the place for you.

"It was fine"
Former EmployeeScientist
Not much to say it was a contract jig. There was no time off and the offered health insurance was not great. I did not have much contact with the people at the company it was just a place that my check came from

"Fun Culture"
Current EmployeeRecruiter
A great place for those who are ready to learn the business (if you are new to it) and then work. There are managers here (with 10+ years' experience) who are ready to teach you the business. There is no room for slacking, but if you don't work, you don't earn commission so that's on you anyway. If you bring a good mind combined with a good work ethic, you will succeed! Yes, you will be on the phone a LOT, it does get easier with time! There is a good balance of work and fun - company events, a company trip, and this summer we had Food Trucks, ice cream, and were able to earn 1/2 day Fridays! (which we did every Friday!)
Pros:
Cons:

"Really reliable, knowledgeable and straight forward with directions"
Current EmployeeRegulatory Specialist
Really professional and transparent with clients regarding the job offers. Detail-orianted and knowledgeable about the job roles and responsibilities. They provided sufficient guidance pre- and post- interviews. Really reliable!