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Senior Manager, Clinical Development Systems

Employer
Eikon Therapeutics
Location
Hayward, California
Start date
Jan 23, 2023

View more

Discipline
Clinical, Clinical Development, Clinical Research
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Job Details

Company Description

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon’s discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.

Senior Clinical Development Systems Manager

The Senior Clinical Systems Manager will be responsible for technical implementation, maintenance and support of the IT systems supporting Clinical Development business function. This hands-on position will be part of the IT Clinical Development System team and report to Sr Director Clinical Development Systems.

About You

You can successfully implement and manage multiple GxP IT systems.  You are also hands on in system implementation and can operate the day to day systems management.  You are also self motivated, organized and detail oriented.  Someone with excellent interpersonal and communication skills.  You are able to collaborate across diverse disciplines and thrive in a fast-paced environment.

What You’ll Do
  • Responsible for the overall configuration, design, and implementation of new Clinical Development Systems.  Work with Business partners, Quality, IT teams, and implementation partners to complete these activities.
  • Responsible for managing change control process for the changes to the system to implement new functionality or periodic vendor software releases.
  • Design, implement and support integration between different applications.
  • Work with business end users and stakeholders to understand business needs to develop system requirements.
  • Responsible for performing system administration, support, user account setup, and maintenance activities for Clinical systems as per established SOPs and support documents. Work with IT teams and Vendor support to resolve any system related issues.
  • Create Validation documentation (including SOPs, configuration specifications and design documents and change control documentation)
  • Be a liaison between the business and IT service providers to coordinate requirements, enhancements, provide integration, and resolve issues.
  • Prepare and maintain documentation pertaining to systems operation and user support documentation.
  • Author and maintain systems and user support documentation.
  • Help to create computer system validation practices including SOPs and Work instructions for full lifecycle of computer systems.
  • Follow good computer system validation practices for implementation and management of computer systems.

Qualifications

  • Bachelor’s degree in Engineering, Information Systems, Computer Science or equivalent with a combination of education/work experience.
  • 10+ years of IT experience in supporting Clinical Development systems such as eTMF/CTMS, Regulatory Information Systems, Quality Systems (Document, Training and QMS) and Biometrics.
  • 8+ years of successful experience in full lifecycle system development (design, implementation, validation and support) of GxP (CFR Part 11 Compliant) SaaS systems such as Veeva Vault, MediData Clinical Applications, Oracle Argus.
  • Vendor Certification(s) are a plus.
  • Good understanding of the CFR Part 11 and Annex 11 regulations for computer systems.
  • Excellent customer service.
  • Collaborative skills in working with a wide range of users.
  • A keen interest in building tools and creating best practices for business teams.
  • Documentation of process flows, functional designs, and system configurations.
  • Planning and scheduling timely completion of projects.
  • Self-starter with the ability to act and operate independently.
  • Natural curiosity to take on new challenges, responsibilities, and gain business knowledge.
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:​
  • 401k plan with company matching​
  • Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)​
  • Mental health and wellness benefits​
  • Weeklong summer and winter holiday shutdowns​
  • Generous paid time off and holiday policies​
  • Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies ​
  • Enhanced parental leave benefit​
  • Daily subsidized lunch program when on-site​

The expected salary range for this role is $157,000 to $180,000, depending on skills, competency and the market demand for your expertise.

Company

Eikon is a pioneering drug discovery and development company that leverages superior engineering and high-performance computing to analyze single molecule protein behavior in living cells. We are engineering a battery of innovative tools and technologies for biological exploration in drug discovery and beyond.

Eikon thrives on the energy and creativity of interdisciplinary teams. We are physicists and chemists, biologists and engineers. We spend our days context-switching between multiple scientific languages. We work with lasers, super-resolution microscopes, and robot arms. We leverage machine learning, cell line engineering, and the collective intelligence of world-class scientists and technologists to observe therapeutically relevant biology in a way no one has before.

We’re endlessly curious, intellectually honest and we love what we do. We’re driven to learn the true mechanisms of biology and pharmacology at the molecular level, to make the biggest difference in as many lives as possible.

Company info
Website
Location
3929 Point Eden Way
Hayward
CA
94545
United States

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