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Senior Consultant - eCOA Services

Rxdefine

MARemoteJob$80–200K/yrPosted 1mo agoVerified open 5 days ago

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At a glance

Compensation
$80–200K/yr
Location
MARemote
Work Authorization
Not specified

Requirements

Credentials this posting asks for.

Bachelor's degree

Job overview

Ostro is hiring a Senior Consultant - eCOA Services. Veeva Systems seeks a Senior Consultant to join its eCOA team, providing end‑to‑end eCOA implementation and design. The role demands strong project and customer management, technical expertise in eCOA build and design, and the ability to lead multi‑study portfolios while driving operational improvements in a fast‑paced, dynamic environment.

Key focus areas include Review protocols and support design and configuration of eCOA, Build, design and consult on eCOA solutions, and Create, review, coordinate and manage deliverables such as timelines, KOM, URS and UAT.

Successful candidates bring Four-Year Degree Or Equivalent Experience, 7+ Years ECOA Industry Experience, and Ability To Travel 5-10%. Important skills include ECOA Build, ECOA Design, Project Management, Customer Management, ECOA Implementation, and Review Protocols. Preferred (not required): Clinical Trial Industry Knowledge, Audit Preparedness, JSON Programming, and EDC.

Skills & qualifications

RequiredNice to have

Skills

ECOA BuildECOA DesignProject ManagementCustomer ManagementECOA ImplementationReview ProtocolsConsult on ECOA SolutionsCreating DeliverablesReviewing DeliverablesCoordinating DeliverablesManaging DeliverablesReview Data Management ActivitiesSupport Data Management QueriesFacilitate Multi-Study PortfoliosLead Multi-Study PortfoliosManage Multi-Study PortfoliosDrive Operational ImprovementsFacilitate ECOA System IssuesTroubleshoot ECOA System IssuesProvide Technical AdviceProvide Technical AssistanceInitiativeProactive WorkSuperior Organizational SkillsSuperior Communication SkillsWork IndependentlyWork in Dynamic EnvironmentWork in Fast-Paced EnvironmentCollaborationLogical Approach to Problem-SolvingExcellent Eye for DetailExcellent Verbal CommunicationExcellent Written CommunicationInterpersonal SkillsPresentation SkillsClinical Trial Industry KnowledgeAudit PreparednessJSON ProgrammingProtocol RevieweCOA ConfigurationDeliverable ManagementTimeline ManagementKOMURSUATData Management ActivitiesMulti-Study Portfolio ManagementOperational ImprovementsTroubleshootingTechnical AdviceOrganizational SkillsCommunication SkillsIndependent WorkProblem-SolvingAttention to DetailCommunicationEDCRTSMFDA E6FDA E821 CFR Part 11ECOA Build and DesignSupport Design and Configuration of ECOABuild ECOA SolutionsDesign ECOA SolutionsFacilitate Delivery of ECOA SystemsTroubleshoot Delivery of ECOA SystemsTake InitiativeWork ProactivelyWork as Part of a TeamData Management ExperienceClinical Data ApplicationsTimelinesSupport Data Management ActivitiesFacilitate ECOA Systems DeliveryTroubleshoot ECOA Systems DeliveryProactive Work EthicLogical Problem-SolvingeCOAData ManagementFDA E6/E8 Compliance21 CFR Part 11 KnowledgeeCOA Solutions ConsultingProactive Work StyleIndependent Working AbilityTeam CollaborationWorking Knowledge of Clinical Data Applications (EDC, RTSM, eCOA)Working Knowledge of FDA E6, E8, 21 CFR Part 11Initiative and Proactive WorkFDA E6 KnowledgeFDA E8 KnowledgePresentationLogical ApproachFDA E6/E8/21 CFR Part 11Proactive InitiativeFDA Regulations (E6, E8, 21 CFR Part 11)ECOA Design and ConfigurationClinical Trial KnowledgeFDA E6/E8/21 CFR Part 11 KnowledgeOrganizationalInterpersonalJSONAbility to Take Initiative and Work ProactivelySuperior Organizational and Communication SkillsProven Ability to Work Independently and as Part of a TeamLogical Approach to Problem Solving and Attention to DetailExcellent Verbal and Written Communication and Presentation SkillsWorking Knowledge of FDA E6, E8, and 21 CFR Part 11ProactiveFDA E6/E8 KnowledgeTravelDetail OrientationAbility to Take InitiativeProven Ability to Work IndependentlyExcellent Verbal and Written CommunicationDetail Oriented

Qualifications

Four-Year Degree or Equivalent Experience7+ Years eCOA ExperienceTravel 5-10%

Benefits

Medical Insurance
Dental Insurance
Vision Insurance
Paid Time Off

Full job description

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors. As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment. Join us in transforming the life sciences industry , committed to making a positive impact on its customers, employees, and communities. The Role Veeva Systems is looking for a consultant to join the Veeva eCOA team. To effectively manage a project, technical expertise in eCOA build and design are necessary, and to effectively build, project and customer management are critical. Consultants for eCOA are tasked with a broad range of responsibilities, requiring excellent project management skills and technical understanding with eCOA design. This role requires owning all areas of eCOA implementation, requiring a holistic understanding of all aspects of the eCOA industry. What You’ll Do

  • Review protocols and support design and configuration of eCOA.
  • Build, design and consult on eCOA solutions
  • Perform highly skilled duties such as creating, reviewing, coordinating, and managing a variety of deliverables (including, but not limited to, timelines, KOM, URS, User Acceptance Testing, and eCOA design and configuration)
  • Review and support Data Management activities and queries.
  • Facilitate, lead, and manage multi-study portfolios and drive operational improvements
  • Facilitate and troubleshoot any issues associated with managing the delivery of eCOA systems
  • Provide technical advice and assistance to other project managers, developers, validation, and customer support staff
  • Acquire new knowledge and enhance your skills Requirements
  • Four-year degree or equivalent experience
  • 7+ years of eCOA industry experience
  • Ability to take the initiative and work proactively
  • Superior organizational and communication skills
  • Proven ability to work independently in a dynamic, fast-paced environment but also as part of a team
  • A logical approach to problem-solving and an excellent eye for detail
  • Excellent verbal and written communication, interpersonal, and presentation skills
  • Ability to travel (~5-10%) Nice to Have
  • Data management experience
  • Working knowledge of clinical data applications (EDC, RTSM, eCOA)
  • Clinical trial industry knowledge
  • Working knowledge of FDA E6, E8, and 21 CFR Part 11
  • Audit preparedness
  • JSON programming Interviewing with Veeva We value your time and believe in a transparent hiring process. Here is the process you can expect.
  • Follow the application process and submit your resume.
  • Within 3 days, you will receive a link to a personality assessment administered by a third party.
  • Once you complete the assessment, our team will review your full application package and follow up via email with our decision.
  • If moving to the interview stage, the process is as follows:
  • A conversation with the hiring manager
  • A practical case exercise
  • A final conversation with our group's Senior Leader.
  • Once all interviews are complete, the manager will be in touch with a final decision. Perks & Benefits
  • Medical, dental, vision, and basic life insurance
  • Flexible PTO and company paid holidays
  • Retirement programs
  • 1% charitable giving program Compensation
  • Base pay: $ 80,000 - $200,000
  • The salary range listed here has been provided to comply with local regulations and represents a potential base salary range for this role. Please note that actual salaries may vary within the range above or below, depending on experience and location. We look at compensation for each individual and base our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in addition to base salary, such as variable bonus and/or stock bonus. #LI-RemoteUS #LI-MidSenior Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. If you need assistance or accommodation due to a disability or special need when applying for a role or in our recruitment process, please contact us at [email protected] .

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