Biotech/Pharmaceutical

Associate Director, Clinical Data Management

Permanent

Penfield Search Partners

Contact: Linda Aronova –  laronova@penfieldsearch.com

Overview: Responsible for working in conjunction with the Clinical Project Manager and study team to ensure data review, project support, study document management and oversight of:

  • Data Management timelines
  • EDC/IWRS set up
  • Study database design
  • Clinical data capture
  • Data discrepancy management and data reconciliation

The Associate Director will provide SME support with Data Management related vendor audits, as well as authoring, review, and revision of company SOPs.

  • This is not a supervisory position
  • This role oversees vendors and/or contractors

Responsibilities

  • Review and provide input into protocols to ensure the data collection, database and reporting requirements can be met and are standardized across the programs
  • Review/revise Data Management related study plans including Data Management Plan, Data Validation Plan and other study documents to ensure quality and standardization
  • Manage and oversee data management related activities with external vendors
  • Work with vendor(s) in preparation of regulatory submissions, particularly to support the Data Management tasks such as transfer of data
  • Develop, review and revise global SOPs providing team training where applicable
  • Manage design and development of eCRFs, clinical review, and communication with applicable vendors
  • Oversee and manage the development and implementation of edit check specifications and work with programmers and applicable vendors during programming & validation
  • Participate in monthly data reviews with clinical team to ensure accuracy, consistency, and reliability of data
  • Work with study teams to ensure study databases are locked based on pre-defined criteria and timelines
  • Ensure that procedures and processes meet business requirements and are adhered to in a consistent manner.

Qualifications

  • Bachelor’s degree required; advanced degree preferred
  • Minimum 10 years of clinical data management experience in a biotech, pharmaceutical or CRO environment
  • Two years of prior management experience needed
  • Hands on experience with Electronic Data Capture systems (Medidata Rave required)
  • Experience with vendor management required, including vendor budgeting and auditing
  • Experience in developing study documents and SOPs
  • Experience with multiple phases of clinical development
  • Excellent communication skills and ability to work in a cross-functional team environment
  • Strong collaboration skills regarding external and internal teams

Travel Requirements: Up to 15% travel, both domestic and/or international.

Tagged as: Associate Director, Clinical Data Management