Clinical Data Management Lead

4 weeks ago

Raleigh, North Carolina, United States Biodata Partners, Inc. Full time
Job Summary

As a seasoned Clinical Data Management professional, you will oversee the end-to-end delivery of data management services for single/multi-service projects, ensuring timely and high-quality deliverables that meet customer expectations. You will provide expert guidance to the Clinical Data Management team, fostering a collaborative environment that drives innovation and excellence.

Key Responsibilities
  • Develop and execute comprehensive project plans, incorporating scope, goals, deliverables, resources, risks, and milestones.
  • Lead the Data Management team in planning, execution, and close-out of projects, ensuring seamless communication and timely delivery.
  • Collaborate with sponsors and stakeholders to develop effective project plans, ensuring alignment with business objectives.
  • Assign tasks and responsibilities to team members, optimizing their capabilities and ensuring timely and accurate results.
  • Ensure adherence to CRO and/or Sponsor Standard Operating Procedures (SOPs) and regulatory guidelines.
  • Provide guidance and mentorship to less-experienced team members, promoting professional growth and development.
  • Assess ongoing and future project resource needs, providing feedback to line management.
  • Triage and resolve issues throughout the project lifecycle, ensuring timely and effective resolution.
  • Ensure project team members' performance supports project budget and delivery requirements.
  • Effectively manage project scope, ensuring changes are documented and approved through change management processes.
  • Participate in and/or contribute to sponsor and/or regulatory audits/inspections.
  • Attend regular meetings with sponsors and/or project teams, providing status updates and discussing data management issues.
  • Track and report quality and performance metrics and KPIs as needed.
  • Participate in in-house and external training courses, enhancing professional knowledge and skills.
  • Adhere to SOPs, ICH-GCP guidelines, and other applicable standards demanded by regulatory authorities.
  • Coordinate and manage training for Investigators, Data Coordinators, and CRAs on selected Data Systems for Data Processing.
  • Ensure quality of data in accordance with DM control documents, generating and submitting queries as necessary.
  • Ensure all clinical data management tasks are complete prior to database lock.
  • Produce and/or coordinate reports and listings for team reviews and DSMBs.
  • Keep the project team and sponsor informed of all issues and timelines, as well as quality and performance achieved.
  • Identify and recommend process improvements and standards to department management, implementing approved process improvements.
  • Assist in development and review of SOPs.
  • Assist with special projects as designated by management.
  • Perform other duties as assigned by management.
Requirements
  • Proven knowledge of clinical data management processes and clinical database systems.
  • Excellent problem-solving, analytical, and communication skills.
  • Ability to work collaboratively in a fast-paced, team-oriented environment.
  • Strong leadership and mentorship skills.
  • Ability to work independently and manage multiple projects simultaneously.
  • Strong attention to detail and quality.
  • Extensive experience within the CRO industry.
  • Extensive knowledge of Clinical Data Management System(s), including Electronic Data Capture system(s).
Education/Qualifications
  • BS/RN in Life Sciences and/or combination of education and experience.
  • Minimum of 8-10 years experience in clinical data management.
  • Strong oral and written communication skills.
  • Effective working knowledge of Microsoft Office Suite, including Word, Excel, and Project.
  • Demonstrated problem-solving, analytical, organization, and time management skills.
  • Demonstrated flexibility and ability to work well in a team environment.
  • Demonstrated ability to be compliant with GCP/regional regulatory guidelines and SOPs.

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