Clinical Design Manager

North Carolina, United States

Clinical Ink

Posted on: July 22, 2020

Closing: August 21, 2020

Salary: Undisclosed

Position Type: Full Time

Job Description

Company Description
Clinical Ink is a global clinical trial technology company that is transforming the clinical trial experience. Founded in 2007, the Company’s proven and future-built eSource platform, which includes solutions for EDC replacement, eCOA, ePRO and more, accelerates time to value while delivering scientific results that matter. With offices in Winston-Salem, NC, and Philadelphia, PA, Clinical Ink is advancing the business model responsible for bringing new treatments to market. Clinical Ink is a global clinical trial technology company that is transforming the clinical trial experience.

Job Description
Clinical Ink is seeking a Clinical Design Manager to join our Study Operations team based in Winston Salem, NC and remotely! The ideal candidate will be highly organized and have great attention to detail, combined with a strong working knowledge/background in clinical research. The Clinical Design Manager's responsibilities will include:

  • Serve as the subject matter expert (SME) for protocol analysis, eSource/eCRF design, and validation programming requirements, during the start-up, build and maintenance phases of a study
  • Review client protocols and other project documentation to assess the scope of the build and communicate it to the appropriate internal teams
  • Work with Study Build Leads to identify needs and resources for study build
  • Define system requirements (i.e. application configuration, form content, metadata, and functionality) based on protocol, data collection needs, data export requirements, regulatory guidelines for collecting source data/applicable standards, and application functionality
  • Conduct client protocol review meetings with internal teams and clients to review inconsistencies, errors, and other items that require further discussion
  • Initiate, review, and route the necessary specifications and maintain timelines for study design deliverables including but not limited to:
    • Section/form requirements and design
    • Visit matrix
    • Cross form reporting
    • Field specifications
    • Study/application configuration requirements
    • Section, form, and study configuration QC
    • Paper source
    • Study configuration
  • Work with Project Management and other internal teams to draft, review, approve, and update applicable project build and change control timelines
  • Communicate with Data Services and Clinical Programming to ensure mapping and export requirements are being met
  • Serve in a consultancy function with partner companies on the proper use of and configuration of Clinical Ink tools that includes but is not limited to translating protocols into eSource forms
  • Work with Project Management to create and present study build slides during kick off meetings
  • Oversee client UAT by creating UAT database and entry forms, managing client UAT kick off and review meetings, addressing/communicating scope issues, and updating study build based on UAT feedback
  • Work with Solutions Development and outside vendors on project specific integrations, including but not limited to: Randomization and Trial Supply Management and Electronic Informed Consent solutions
  • Create study specific Quick Reference Guides
  • Assist with preparing for Investigator meetings by reviewing studies with Project Management and Training to ensure that they are prepared to answer study related questions
  • Attend Investigator Meetings as needed
Qualifications
  • A/BS in a scientific field or equivalent work experience in clinical research
  • 5+ years’ experience in clinical research
  • Ability to conceptualize large study builds and anticipate protocol translation challenges
  • Must have extensive knowledge of complex scientific/office procedures and techniques relating to clinical research and patient care to accurately design source documents used to conduct clinical trials
  • Ability to organize, instruct and supervise staff, while promoting group effort in a matrix environment
  • Demonstrated ability to manage conflicts and resolve problems effectively
  • Excellent communication skills, organizational skills, and attention to detail are required
  • Ability to identify needs/issues, track progress, and follow through on actions to achieve customer satisfaction
  • Skilled in communicating needs/issues, impacts, and corrective actions to varying levels of internal and external personnel
  • Experience with MS Office including Word, Excel, and PowerPoint
  • Possesses thorough knowledge of the Good Clinical Practice (GCP) guidelines and applicable FDA and ICH regulations for conducting clinical trials; working knowledge of CDISC standards
  • Licensure/Certification/Registry: Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) licensure is desired
  • Ability and willingness to travel up to 25%
Additional Information
Clinical Ink is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or handicap, or veteran status. 
www.clinicalink.com ​

Clinical Ink

Posted on: July 22, 2020

Closing: August 21, 2020

Salary($): Undisclosed

Position Type: Full Time

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