The Director of Clinical Data Management (CDM) will lead and provide oversight of data management activities across one or more programs and is accountable for all operational activities for multiple studies under one or more programs at Keros Therapeutics.

They will support and guide CDM decision-making from startup to closeout by working with internal CDM staff and internal/external cross functional teams involved in a clinical trial. The Director will ensure all CDM activities are being performed within quality and timeline expectations while adhering to standard operating procedures (SOPs) and industry best practices. This position will manage the resources and workload of the CDM teams across projects and will review, support and manage the CDM contract/budget review/approval across studies.

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 and will be expected to perform hands-on activities when required to ensure lock-ready status of clinical trial data. The Director, CDM will engage external data management teams at CROs and maintain effective and frequent communication with CDM counterparts and escalation pathways to mitigate data quality and timeline risks for all CDM activities.

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.
• Provides leadership and coaching of CDM staff to execute all aspects of CDM activities across projects and mentors internal staff and contractors.
• Works with Biometrics leadership to identify and establish departmental objectives, authors CDM standard operating procedures (SOPs), work instructions and establishes standard data collection and reporting based on CDISC.
• Provides subject matter expertise to CDM staff when reviewing clinical study documents and provides focus to project specific processes.
• Plan, coordinate, and manage data management tasks and timelines across multiple studies and programs.
• 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, Clinical Pharmacology 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.
• Focuses and improves process efficiency across CDM deliverables: CRF finalization, clinical database design/validation, data management plan and edit checks finalization, ongoing manual clinical data reviews and data reconciliation, third party vendor data transfers, clinical database lock and final DM project file documentation.
• 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 10 years of proven success with increasing responsibilities in clinical data management in a CRO, Biotech or Pharmaceutical company.
• Experience with global studies, using an outsourced CRO model.
• Demonstrated proficiency managing the lifecycle of clinical data projects.
• Experience developing specifications and reports using JReview, Spotfire or other CDM reporting tools.
• Proficiency with EDC databases. Experience with Medidata Rave is expected.
• 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 WHODrug.
• 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.
• Excellent analytical, problem-solving skills and attention to detail.
• 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.
• Ability to solve complex problems in all areas of CDM.
• Ability to provide leadership on a cross-functional team setting and communicate CDM strategies and best practices in a team environment.

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