Job title: Data Management Consultant
Job type: Interim / Project consulting
Emp type: Part-time
Industry: Biotechnology
Expertise: Pharmaceutical / CRO / Reagents / Personal Care
Pay interval: Hourly
Location: Raleigh-Durham, North Carolina
Job published: 13 May 2020
Job ID: 32041

Job Description

 

Position:

Data Management Consultant

Department:

Consulting

Contract:

Up to 6 months

Employment Type:

Contract

Location:

Raleigh-Durham, North Carolina / Remote

 

Company Background

Our client is a specialist life sciences consulting company that provides product development and regulatory consulting to Pharmaceutical, Biotechnology, Generics and Medical Device companies. The company has worked with the worlds leading companies, guiding them through their key product development and regulatory decision milestones, from proof of concept to commercialization and post marketing.

 

Job Responsibilities

  • Work with our clients, managing end to end and overseeing external data management vendors, whilst providing input on DM vendor contracts, budgets and timelines.
  • Participate in all data related activities and meetings, including internal, our client’s, and vendor team meetings.
  • Provide subject matter expertise in all functional data management activities for our clients.
  • Manage activities that include but are not limited to: good data management process, data deliverables that follow study milestones, data system set up and review, data reconciliation, data standards, and data encoding.
  • Provide data management progress updates at client team meetings, and an overview of deliverables that follow study timelines.
  • Acquire and maintain MedDRA and WHO DD limited licenses for client to ensure compliance with regulations.
  • Ensure proper development and maintenance by our clients vendor, of applicable deliverables and data related study plans including, eCRFs (RAVE), Data Management Plan, Data Validation, CRF Completion Guidelines, Annotated CRFs, SDTM data specifications, Coding Management Plan, AE/SAE Reconciliation Plan, Medical Monitoring Data Review Plan, etc.
  • Review, and approve eCRF training for site and our client’s staff. Participate in and/or deliver eCRF training as appropriate.
  • Ensure data vendor is managing clinical study data, and providing at least bi-weekly eCRF completion and data validation metric reports to sponsor Data Operations/Management contact.
  • Ensure the data vendor is properly managing data per their Data Validation and Quality Control Plan; including resolving outstanding issues related to data integrity, and data reconciliation. Ensure the vendor is escalating outstanding issues to DM and Clinical Management on real time and ongoing basis.
  • Provide input in the development of the study Risk Management Plan.
  • Manage and ensure the data is being provided in the proper SDTM format and version from data vendors.
  • Work with biostatistics and programming on data specification issues that may impact submission deliverables.
  • Review and approve any data transfer specifications between client and clients data vendor, and vendor and central laboratories.
  • Oversee data vendor database lock activities, and ensure activities are meeting set milestones and data deliverables from vendor of submission ready quality for regulatory authority updates (e.g., annual reports) and submissions.

 

Essential Skills/Qualifications

  • BS degree in a relevant scientific discipline (MS/MBA or doctoral degrees preferred).
  • Minimum 8 years data management experience in the pharma/biologics/device industry or other related experience
  • Demonstrated leadership capability.
  • Excellent communication, negotiation, and interpersonal skills.
  • Organized, results-oriented, and strategic thinker.
  • Familiarity with the drug/biologic or device development process, with significant knowledge in one or more functions (e.g. CMC, non-clinical, clinical, regulatory, etc.).
  • Proficiency in independent thought and reasoning ability.
  • Ability to communicate complex issues in a concise, coherent, and professional manner.
  • Ability to negotiate difficult issues in a well thought out and professional manner.
  • Ability to work effectively under pressure to meet deadlines.
  • Ability to interpret a variety of instructions provided in written, oral, diagram, or schedule form in a short amount of time.
  • Travel to customer and project team meetings may be required.