Peloton Therapeutics: Clinical Data Manager

Job Title:               Clinical Data Manager

Position Code:   2100170927

Location:               Peloton Therapeutics, Inc.

Education:           BA or BS

Career Level:      5+ Years Experience with a CRO or Sponsor

Date Needed:     November 2017

Job Type:              Full-time/Exempt

Travel:                   Less than 20 percent (Domestic and International)

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Peloton Therapeutics:

Peloton is dedicated to developing first-in-class, highly effective medicines for life-threatening diseases by leveraging great science, talented employees, and productive collaborations. We are seeking high-caliber individuals to join our growing team and contribute to our culture of collaboration, innovation, excellence, and shared sense of purpose. If you are passionate about improving patient outcomes, are driven to be the best at what you do, and are ready to make a positive impact, we invite you to apply to join our team. We offer an attractive compensation package including company ownership, competitive salary, comprehensive benefits, and the opportunity to be part of a dynamic biotech environment.

Job Description:

This is an exciting opportunity for a highly motivated individual to oversee the data management of clinical projects and studies within agreed upon budgets and in accordance with applicable regulations and in keeping with corporate goals.  The successful candidate must have an excellent knowledge of clinical research and data management processes as well as a solid understanding of regulatory and industry rules and guidance to support drug development.

Responsibilities:

  • Provide oversight of clinical data management activities across one or more early stage studies
  • Direct the development and maintenance of Case Report Form (CRF), CRF Completion guidelines, edit check specifications, data transfer specifications, and database audit plans
  • Hands-on oversight of the build and development of the integration of IXRS (if applicable) with EDC (Inform) and oversee change controls
  • Perform and organize cross-functional User Acceptance Testing (UAT) of the integrated clinical databases
  • Contribute to the design and development of study documents including Clinical Protocol, Case Report Forms (CRFs), and Statistical Analysis Plan (SAP)
  • Direct the interaction with contract data management groups to ensure that data management tasks remain on target per project timelines
  • Proactively organize on-going data review throughout the conduct of the study to ensure timely and appropriate identification of errors, trends, and discrepancies by working with a contract data management group and internal stakeholders
  • Responsible for the correction of errors and discrepancies through the site query process, for documenting permanent data issues, routinely communicating issues with team members, and the delivery of a quality locked database for analysis
  • Provide input to complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
  • Exercise judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results
  • Contribute to data management initiatives such as remote and central monitoring
  • Participate in the RFP process including the evaluation of potential vendors
  • Contribute to the evaluation of CRO data management function inspections and audits
  • Contribute to the development and implementation of departmental policies, standards, and process improvement initiatives

Job Requirements:

  • Bachelor’s degree in clinical, biological, mathematical sciences or related field or equivalent experience required; advanced degree is a plus; equivalent experience may be accepted in lieu of degree requirement
  • Minimum 5 years of clinical data management experience in biotechnology or pharmaceutical industry with outsourced CRO oversight experience; previous oncology experience is preferred
  • Minimum 5 years of Electronic Data Capture (EDC) experience; IXRS integration a plus
  • GCP and regulatory knowledge including FDA and ICH regulations
  • Strong organizational, problem-solving, and priority management skills
  • Excellent interpersonal and communication skills (both written and oral)
  • Experience with Oracle Inform preferred
  • Occasional travel

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Hires Needed:                        1

Wage Amount:                      Based on Experience

Company Contact:               hr@pelotontx.com

Peloton Therapeutics, Inc. is an oncology drug discovery and development company focused on advancing first-in-class small molecule therapies that provide patients suffering from life-threatening diseases with new therapeutic options. The company is driving forward multiple oncology programs targeting unexploited molecular vulnerabilities including adaptive processes that are induced in the tumor microenvironment by hypoxia, nutrient stress, and that result in evasion of anti-tumor immune responses.  http://pelotontherapeutics.com