Sr. Clinical Data Manager

Responsibilities

• Provide leadership, strategic planning, direction and implementation of clinical systems for data collection, including vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelines.
• Perform or provide oversight to staff for all CDM activities from study startup to archival: design CRFs/eCRFs, create Data Validation Specifications, Data Management Plans, eCRF Completion Guidelines, and Data Review Plans; code terms in MedDRA and WHO Drug; complete database lock, archival, and closeout activities.
• Develop and manage standard operating procedures (SOPs and CLPs) for clinical investigation data management, including Data Management Plans (DMP), eCRFs, user acceptance testing (UAT) plans and scripts, EDC build and associated edit checks.
• Provide study‑level metrics and reports, and establish external data reconciliation processes related to CRF review, query status, data entry, monitoring status, management of independent review vendors, and other relevant matters; translate metrics into performance assessments and improvement opportunities.
• Collaborate with cross‑functional teams and management to implement and govern CDM processes and standards that meet all applicable quality requirements and regulations, overseeing all phases of data management activities.
• Provide program‑ and study‑level oversight and expertise for CDM activities across multiple studies.
• Review clinical data continuously to ensure consistency, integrity, and accuracy; assess and identify key data issues, trends, or patterns that could affect study compliance or data quality.
• Establish external data reconciliation processes and develop CDM procedures for adjudication of independent reviews of video‑endoscopies, CT scans, and similar data.
• Evaluate and manage CROs and external technology vendors to meet company goals and CDM standards.
• Build and foster positive relationships and teamwork within the clinical team and partnering sites with a professional demeanor.
• Make decisions and chart course through careful evaluation of risks and benefits with limited information, serving as the interdepartmental subject‑matter expert for the CDM area.
• Assist with routine quality audits as applicable.

Requirements

• Bachelor’s degree in a scientific discipline (RN or advanced degree preferred).
• 9 years of industry experience in CDM across all study phases from startup to archival, with at least 5 years in a lead role for clinical development programs involving medical devices leading toward FDA filing/approvals.
• Thorough knowledge of CDM standards for medical devices (Class III PMA devices preferred).
• Expertise in development, validation, and management of the clinical study database throughout its lifecycle, including CRF design, database development and testing, discrepancy management, data quality review, and database close‑out and lock procedures; familiarity with CDASH and SDTM data formats.
• Working knowledge of GCP, ICH, and FDA guidance and regulations for clinical trials.
• Working knowledge of MedDRA and WHODrug dictionary coding terms.
• Ability to complete tasks independently, accurately, and efficiently with strong attention to detail and timely management.
• Experience implementing, validating, and administering other clinical data collection systems (e.g., eSource, IVRS, IWRS, core‑lab web‑based portals).
• Demonstrated ability to manage complex projects with tight timelines and overcome project roadblocks.
• Excellent verbal and written communication skills.