Associate Director, Clinical Data Management

The Associate Director of Clinical Data Management (CDM) will lead data management activities in support of studies across all stages of clinical drug development at Keros Therapeutics.

They will ensure that clinical data capture, systems, and processes lead to accurate, consistent, high quality, and complete data. They will be responsible for data management oversight at the study and program level.

The candidate will provide clinical data management oversight of outsourced clinical trials including but not limited to, project management, vendor management, coordination of internal reviews, and approval of deliverables. The candidate will impact multiple clinical development programs, health authority submissions, presentations, and publications across internal and external stakeholders.

Primary Responsibilities:

• Oversee all end-to-end CDM activities outsourced to contract resource organizations.
• Ability to perform hands-on execution of all CDM activities from startup to closeout periods as needed.
• Plan, coordinate, and manage data management tasks and timelines across multiple studies and programs.
• Mentor internal staff and contractors.
• Act as primary liaison with CROs, third party data vendors, and EDC vendors for assigned studies and programs.
• Collaborate with internal clinical study team to ensure all stakeholders’ needs are addressed.
• Ensures achievement of data management deliverables and milestones in coordination with cross functional team members including: Clinical Operations, Clinical Development, Biostatistics & Programming, Biomarker Operations & Sample Management and Pharmacovigilance
• Primary author/approver for CRFs, CCGs, edit check specifications, SAE reconciliation plans, Coding plans, data transfer specification, Data Management Plans, and other key data management documents.
• Oversee clinical database design, production and UAT cycles, ensuring that the CRO meets the highest quality standards.
• Ensure database design and process consistency within and across programs.
• Accountable for external data vendor documentation, management, and reconciliation.
• Oversees the tracking of important study metrics on data entry, source data verification, query status, data trends and communicate with relevant functions regarding study status/issue resolution.
• Lead, facilitate, and conduct internal DM and cross functional review of clinical data.
• Support GCP inspection readiness.
• Contribute to departmental SOP and process development and improvement, and integration of technology.
• Contribute to the development of and ensure adherence to Clinical Data Standards.

Qualifications:

• Bachelor’s degree in a health-related field.
• Minimum of 8+years of proven success in clinical data management in a Biotech or Pharmaceutical company
• Experience with global studies, using an outsourced CRO model.
• Demonstrated proficiency managing the lifecycle of clinical data projects.
• Experience developing reports using JReview or other CDM reporting tools.
• Proficiency with EDC databases.  Experience with Medidata Rave is highly desirable.
• Working knowledge of, and experience with CDASH/SDTM/CDISC standards.
• Experience working with central and specialty labs/vendors.
• Knowledge of medical terminology and medical coding dictionaries including MedDRA and WHO.
• Working knowledge of GCP, ICH and FDA requirements as applicable for Clinical Data Management.
• Able to manage multiple initiatives and shifting priorities within a small company environment.
• Strong analytical and problem-solving skills
• Excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team environment.
• Excellent written and oral communication skills.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

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