Clinical Trial Manager
WinSanTor
San Diego, CA
Job description

About us

WinSanTor is developing potentially the only disease modifying treatment for peripheral neuropathy, a disease that affects over 30M Americans alone. The company was incorporated by assembling the leading experts funded by the leading stakeholders to solve this significant unmet need. The company now is focused on patient impact.

Clinical Trial Manager

REMOTE

WinSanTor is looking for detail-oriented Clinical Trial Manager who excels at problem solving to help the company initiate, conduct and finalize clinical studies.

Summary

  • Benefits Offered Home based in San Diego
  • Employment Type: Full Time

Clinical Trial Manager

Overview

We are looking for a person that is good at getting stuff done.

Stuff = development of clinical development planning and strategy, clinical study planning and execution within pre-specified clinical development program, timelines and budget, preparation of study related materials, relationship management between study sites and vendors (in particular CROs), supervision of study related activities, identification of project risks and contingency planning

Working Environment

WinSanTor is a very entrepreneurial company with a lean team of do-ers. Candidate must be self -motivated/-initiated/-sustaining to manage multiple tasks at the same time. WinSanTor has a very small team. Therefore, candidates must be able to do and solve various problem without reliance on others.

Candidate MUST (be):

  • Comfortable working in a fast-paced environment where priorities are changing daily. This skill is critical for this position
  • Very detail-oriented and thorough
  • Know how to work in a "start-up" or small biotech environment (please apply only if you have such experience)
  • Have a strong-sense of ownership of projects - candidate will be responsible for the completion of each project
  • Nimble, dynamic, innovative - able to solve problems quickly
  • Project and solution oriented
  • Comfortable with working remotely and independently - complete tasks without someone babysitting them

Please do not apply if you need instructions for every step.

Summary of Responsibilities

  • To assist the Clinical Operations teams in completion of all required tasks to meet project goals including study set-up and conduct
  • To provide general administrative support to the Regulatory team · Assist with internal and external audit preparation and quality control audits of clinical study documentation
  • To be familiar with ICH GCP, appropriate regulations, and internal SOPs and tracking systems
  • Assist with the writing and production of study documents and tools, including study protocols, consent forms, project plans budgets, logs, templates and other documents, as needed
  • Research vendor capabilities and cost to determine feasibility in studies
  • Works with vendors to prepare and revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
  • Track, assemble, distribute and manage clinical supplies, i.e., management/oversight of ordering, tracking, and accountability of investigational products and trial materials
  • Perform periodic reviews of the CRO and/or in-house eTMF/TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines
  • Interacts with other functional areas and key stakeholders, including Clinical Development, Data Management, Finance, Regulatory, R&D, Clinical Supply (Investigational Product) and clinical vendors (e.g., central laboratory, CROs), as needed, to support clinical trial activities
  • Assure clinical studies are compliant with ICH/GCP and other regulations as appropriate
  • Obtains and maintains in-depth understanding of the study protocol and related procedures in order to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement and providing training as appropriate/require

Qualifications:

  • Must have a growth mindset, be a self-starter and be “hands-on”.
  • BA/BS (minimum) in related scientific or healthcare field, a combination of relevant education and applicable job experience may be considered
  • 5 years of CRA or CTM experience in a Biopharmaceutical or Pharmaceutical company, with Phase 1 through 4 studies, both domestic and international
  • Experience in running a trial from start to finish; initiating the trial that includes protocol writing, ICF generation, site feasibility/start-up training, contract and budget negotiation, vendor management, CRF design, maintaining a trial and study close-out
  • Apply project management best practices to programs. Experience in novel clinical drug development
  • Experience with protocol, ICF, CRF, CSR development and review
  • Fluent in English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively
  • Excellent understanding and working knowledge of clinical research, phases of clinical studies, current ICH GCP and country clinical research law and guidelines
  • Excellent understanding of global, country/regional clinical research guidelines and ability to work within these guidelines
  • Hands on knowledge of Good Documentation Practices
  • Performs independently and professionally when managing both site/vendor oversight and monitoring responsibilities, and as applied across multiple protocols, sites and therapeutic areas
  • Strong IT skills (use of MS Office, use of various clinical IT applications) and ability to adapt to new IT applications on various devices

TRAVEL:

Travel may be required up to 25% of your time

Job Type: Full-time

Pay: $80,000.00 - $140,000.00 per year

COVID-19 considerations:
We are an entrepreneurial company that a mindset of getting things done. That has always meant we worked virtually and remotely, without fixed schedules - so long as the work gets completed. COVID-19 has not slowed down the pace of the company.

WinSanTor provided the following inclusive hiring information:

We are an equal opportunity employer and considers all qualified applicants equally without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

Job Types: Full-time, Part-time, Temporary

Pay: $80,000.00 - $140,000.00 per year

Benefits:

  • 401(k) matching
  • Dental insurance
  • Health insurance
  • Health savings account
  • Vision insurance

Schedule:

  • Monday to Friday

COVID-19 considerations:
We are an entrepreneurial company that a mindset of getting things done. That has always meant we worked virtually and remotely, without fixed schedules - so long as the work gets completed. COVID-19 has not slowed down the pace of the company.

Work Location: One location

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