Clinical Trial Manager

Clinical Trial Manager
  • Competitive
    HOUR
  • Permanent
  • Los Altos CA, US Los Altos SANTA CLARA US 94022
Job Ref: JO000130813
Sector: Clinical
Sub-sector: Clinical
Date Added: 05 May 2022

Our Client is an exciting biotech startup attacking cancers from a different and logical angle currently in a Phase 3 registrational trial for our first indication: locally advanced pancreatic cancer. Their therapy platform utilizes approved chemotherapeutics with validated mechanisms of action and well-established safety and side effect profiles, with the goal of increasing their efficacy, improving their safety, and widening their therapeutic window. They have secured FDA Orphan Drug Designation in our first two indications: pancreatic cancer and bile duct cancer (cholangiocarcinoma). Their previous studies demonstrated a median overall survival of 27.9 months versus expected survival of 12-15 months in patients receiving only intravenous (IV) systemic chemotherapy. Their Phase 3 trial is 40% enrolled as of April 30, 2021 and they plan to further build out the platform within the next several months.

Sr./Clinical Trial Manager Job Description

We are seeking an experienced Senior Clinical Trial Manager/Clinical Trial Manager to successfully manage and execute one or more clinical trials/programs with minimal supervision: a candidate who is a hands-on leader who understands the fast-paced start-up environment and can manage all aspects of our clinical development including handling the needs of a Phase 3 pancreatic cancer randomized trial, upcoming Phase 2/3 bile duct cancer trial, and other upcoming oncology trials. Being resourceful with excellent problem-solving skills is key. Must be able to manage all clinical operational aspects of a clinical trial/program from site selection, startup, enrollment, maintenance, and close-out. Must be attentive to detail and able to contribute to writing study protocols, informed consent forms, study manuals, develop SOPs, etc.

This position will have at least 2-4 direct reports and report to the Director of Clinical Operations and Research with high potential for growth opportunity.

Responsibilities:

  • Overall management of multi-center oncology trials conducted by the company- Responsibilities include:
    • Become a subject matter expert on clinical trial protocols
    • Respond to questions from Study Sites regarding protocol and study conduct as they arise
    • Overseeing patient enrollment including enrollment goals and timelines
    • Overseeing data collection and monitoring
  • Submissions and communications to/with IRBs/ECs
  • Work with internal and external teams including, but not limited to, safety, regulatory affairs, statisticians, CROs, and others as necessary
  • Coordinate communication with Data Monitoring Committee/Data Safety Monitoring Board and organize regular meetings
  • Maintain Clinical Research Project status and present updates to company’s weekly meetings and to management as needed
  • Establish study/program milestones and ensure accurate tracking and reporting of study/program metrics and timelines, and critical study activities
  • Develop and maintain enrollment and budget forecasts
  • Oversee team of 2-4 employees and contractors (i.e., Clinical Assistants, Clinical Research Associates, Clinical Specialists, Monitors, etc.)
  • Manage CROs and third-party vendors to ensure delivery against contracted scope of work and budget
  • Participate in selection of CRO and vendors including development of RFPs, budget negotiations and management
  • Develop and Finalize ICFs, protocols/amendments, IB, site budget/CTA and contribute to IND filings
  • Oversight and project management of individual studies as well as relevant program related activities with minimal supervision including managing team meetings (Agendas, Minutes, Action Items, Follow Up)
  • Develop study plans, including vendor oversight, risk, safety, communication
  • Provide supervision, coaching and mentoring, and contribute to hiring new staff
  • Proactively identify risks, develop and implement mitigation strategies
  • Oversee other clinical studies/goals in the future as determined by the company
  • Other assignments may be added in the future

Required Education:

  • Bachelor’s degree in a scientific or healthcare discipline

Required Experience:

  • Minimum of 6-10 years of experience in clinical research including oncology experience (sponsor or CRO)
  • At least 4 years clinical trial management experience
  • Experience in clinical trials and clinical data analysis within the industry
  • Experience in managing employees

Required Skills:

  • Ability to read, analyze, and interpret complex clinical data
  • Excellent communication skills, organization skills, and attention to detail
  • Excellent computer literacy skills
  • Efficiently prioritize multiple tasks and utilize time management
  • Ability to work well with a small team and an independent self-starter
  • Ability to take the lead and responsibility on multiple projects as well perform the entire spectrum of work as needed
  • Able to manage large databases and maintaining paper and electronic documents
  • Ability to work well under pressure and time constraints for competing priorities
  • Well-developed focus, and teamwork skills
  • Smart, efficient, and even- tempered
  • Self-motivated and able to thrive in a fast-paced, start-up environment
  • Energetic, forward-thinking, and creative
  • High ethical standard and appropriate professional image
  • Analytical ability, technical skills, good judgment, and project management experience
  • Possess the ability to see a larger picture perspective and is well versed in the different aspects of the company operation
  • Must have exceptional leadership skills, including motivation and delegation

Essential Mental/Physical Functions:

  • Sit for extended periods of time using a computer or phone
  • Share a workspace and maintain good order
  • Lift up to 20 lbs. infrequently
  • Work alone or with others in a small office environment
  • Travel to clinical sites as necessary this position is an in-house position but may require some travel (<20%) to clinical site

Equipment/Software Used:

  • PC proficiency
  • Microsoft Office (Word, Excel, PowerPoint, and Outlook)
  • Various EDC systems (i.e., MediData)
  • Office Equipment (scanner, copier, phones)

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

#LI-DW1

Keywords: clinical trial manager, ctm, clinical research

SRGTalent https://www.srgtalent.com https://www.srgtalent.com/-/media/srg/1---new-website/logos/website-logo-all-padding-removed.png
07/06/2022 12:00:00
USD 0.00 0.00 Hour
Contact Consultant:
Danielle Wilson

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