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Principal Clinical Data Manager

Revision Date: 14-APR-2021

Primary Function of PCDM Position

Responsible for performing or have oversight for simple to complex data management tasks at ARA.

Position Description & Responsibilities

A Principal Clinical Data Manager (PCDM) will be responsible for performing all data management tasks at ARA. They will act independently as a lead data manager on multiple projects of potentially high complexity and act as support data manager on other projects as assigned. As a lead data manager on a project, they will be the primary point of contact for the client on data management topics and will manage the project timelines, resourcing, and budget for all data management-related tasks for that project. They may provide project oversight to other data management staff or act in a mentorship role.

A PCDM should be possess an understanding of therapeutic areas and indications under study by ARA clients and be able to identify and provide solutions to data management issues. They may be responsible for reviewing or preparing study documents as they relate to data management. They may be asked to review/prepare documents associated with regulatory submissions, attend meetings and/or provide responses to questions raised from a regulatory perspective. Familiarity with US and OUS regulatory requirements, guidance and trends is required.

 PCDM may specify, build, manage or oversee team members in all aspects of database design and build. Knowledge of industry standards for data collection and reporting (ex. CDASH, CDISC) are necessary to both advise client database design and consider impacts and/or efficiencies as related to downstream programming and statistical reporting activities.

Job Responsibilities

  • Use of Clinical Data Management Systems – being able to design, build, test and/or act as an end user
  • Create user/data entry instructions, perform EDC user training (video, meetings, web, etc.)
  • Write and Review Data Management Plans, Data Review Plans, Coding Guidelines, UAT Plans, and other supporting data management documents
  • Perform data review, query writing, query management and tracking
  • Coding of raw data terms to standardized dictionaries (ex. MedDRA, WHO Drug)
  • Write Data Transfer Agreements, handle and manage external data sources, data reconciliation
  • Handling and management of local lab data, including reference ranges
  • SAE reconciliation
  • Working with other vendors/partners (ex. monitoring groups, core labs, etc.)
  • Consult with clients on data collection strategies and implications; coach clients who wish to build their own databases
  • Support regulatory filings for clients and support ARA project teams when involved in regulatory filings.
  • Assist in the development and review of functional area SOPs, guidelines and templates
  • Other duties as assigned.

Job Requirements

  • 10+ years of experience performing data management tasks in clinical research including relevant practical experience.
  • Bachelor’s degree or higher and familiarity with advanced methodologies commonly implemented by the pharmaceutical industry.
    2+ years management or mentoring experience preferred
  • Experience in a service (CRO) type environment is preferred.
    Working knowledge of EDC systems, especially Rave, Medrio and iMednet.
  • Broad and deep understanding of the regulatory process in the US and abroad.
  • Thorough knowledge of regulatory rules and guidelines as relevant to clinical trials.
  • Working knowledge of Word Processing software, Microsoft Project, Microsoft Outlook, database software and Spreadsheet software.
  • Excellent written and verbal communication skills including listening, negotiation, and presentation.
  • Proven ability to successfully interface with all levels of employees and management including executive staff.
  • Proven ability to effectively collaborate, communicate, and influence throughout all levels of the organization.
  • Strong analytical skills and a proven ability to establish business and financial justifications for product initiatives.
  • Clinical product registration development and regulatory submission experience preferred.
  • Complex and/or international trials experience is required.
  • Ability to travel if needed to meet with study sponsors, attend investigator meetings, etc. approx.10% of the time.


  • Clear, direct communication style
  • Able to work successfully with different personalities and work styles.
  • Dedicated work ethic with attention to results and productivity
  • Strong sense of accountability for company and professional goals
  • Works well under pressure
  • Able to take the initiative on unfamiliar tasks.
  • Professional demeanor
  • Possesses a positive attitude.
  • Entrepreneurial, proactive, detail oriented, and professional
    Willing to provide “hands-on” leadership to teams and projects when needed.
  • Flexible, disciplined management style
  • Confident, focused, and passionate about working in a growing organization to foster success in a competitive, fast-changing global marketplace.
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