Clinical Data Associate IV

Cambridge, MA

Contract

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Clinical Data Associate in Cambridge, Massachusetts. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity

RESPONSIBILITIES

  • Investigate, evaluate and propose the use of emerging technologies (e.g., electronic data capture) in clinical data management
  • Work with the Global Medical Director and project team in designing and developing Case Report Forms (CRFs)
  • Create the following documents for the clinical database in Electronic Data Capture (EDC); database specifications, data validation (edit checks) specifications, report specifications and other functional specifications
  • Good working knowledge of CDISC-SDTM, ODM, CDASH guidelines
  • Develop and maintains X-Registry eCRF library and validation checks
  • Create User Acceptance Test (UAT) Plans, Test Scripts and execute testing
  • Lead and assign user accepting testing to data management peers and oversee the completion of the testing
  • Execute assigned QC/QA procedures to ensure that clinical databases meet corporate and regulatory standards with accuracy and completeness
  • Perform activities related to the implementation, development, maintenance and training of the existing system, e.g. gathering system change requests, incorporating recommendations from users and contributing to system enhancements
  • Collaborate with a highly motivated and experienced data management team on process improvement and implementation of new technology
  • Participate in the development of global, inter-departmental harmonized SOPs, and registry specific guidelines
  • Collaborate with data management peers and other functional departments to define and develop operational type reports to assist with data exploration and metrics for management team
  • Develop training materials and provide training on technical applications to data management peers and Site Operations personnel
  • Create and manage data management workflow documentation, to include, but not limited to; Data Review Guidelines, eCRF Completion Instructions, Data Validation Plan and Data Management Plan
  • Work together with technical vendors and data management team to troubleshoot database bugs/issues from root cause to resolution
  • Responsible for tracking individual project tasks and overall project timelines
  • Review and approve technical vendor contracts, change orders and invoices

EXPERIENCE

  • Minimum of 9 years of data management experience in the Pharmaceutical/Biotechnology industry

EDUCATION

  • Bachelor’s degree in related science/technical discipline required

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately

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