Clinical Data Manager

Washington, DC

Perm Salary

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OVERVIEW

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

You must have extensive experience in maintaining quality and accuracy of a database for a clinical study in the pharmaceutical industry. And your experience has provided you knowledge of regulatory guidelines relevant to clinical documents, including Case Report Forms, Data Clarification Forms, and etc.  

RESPONSIBILITIES

  • Serve as the Lead Data Manager on multiple studies
  • Design and modify eCRFs and EDC edit checks
  • Responsible for building, review and validation of clinical database
  • Create and maintain project DM documentations
  • Extract and monitor the trial data to identify issues
  • Manage CDM activities in CRO and other vendors
  • Mentor or train other junior members

EXPERIENCE

  • Minimum of 3 years of experience in Clinical Data Management from CROs or Pharmaceutical companies
  • Experience in electronic data capture (EDC) systems
  • Knowledge of ICH/GCP guidelines and FDA regulations
  • Knowledge of industry data standards (CDISC, SDTM, CDASH)
  • Excellent organizational skills
  • Outstanding interpersonal, oral and written communication skills

EDUCATION

  • Minimum of BS preferably in Health Sciences, Statistics, MIS or Informatics

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.

847-267-1176