Sr. Clinical Data Manager

Katalyst CRO; Boston (MA); On-site; USD 90,000 - 120,000; Part time

Job summary

A clinical research organization is seeking a Sr. Clinical Data Manager with 9 years of industry experience and extensive knowledge in clinical data management for medical devices. This role focuses on leading data collection systems and ensuring data integrity throughout all study phases. Ideal candidates should have a Bachelor's degree in a scientific discipline and should possess strong leadership and project management skills. This is a contract position with a mid-senior level designation.

Qualifications

• 9 years’ experience in clinical data management across all study phases.
• 5 years in a lead role for clinical development programs with medical devices.

Responsibilities

• Provide leadership and strategic planning for data collection systems.
• Collaborate with the team to implement CDM processes.
• Review clinical data for consistency and accuracy.

Skills

Leadership and strategic planning

Expertise in clinical data management standards

Project management

Attention to detail

Education

Bachelor's Degree in a scientific discipline

Tools

MedDRA and WHODrug coding terms

EDC systems

Job description

Join to apply for the Sr. Clinical Data Manager role at Katalyst CRO.

Responsibilities

• Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelines, etc.
• 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; and complete database lock, archival, and closeout activities.
• Develop and manage standard operating procedures (SOPs) and CLPs for clinical investigation data management; Data Management Plans (DMP), eCRFs, user acceptance testing (UAT) plans and scripts; EDC build and associated edit checks.
• Provide study‑level metrics/reports and external data reconciliation processes relating to CRF review, query status, data entry, monitoring status, management of independent review vendors, and any other relevant matters; translate metrics into performance assessment and opportunities.
• Collaborate with cross‑functional team and management to implement and govern CDM processes and standards to meet all applicable quality requirements and regulations, manage and oversee all phases of data management activities.
• Provide program/study‑level oversight and expertise for CDM activities for multiple studies.
• Review clinical data on an ongoing basis to ensure consistency, integrity and accuracy; assess and identify key data issues, trends or patterns that may pose overall study compliance and/or data quality concerns.
• Establish external data reconciliation processes; develop CDM processes for management and determination of adjudication for independent review of video‑endoscopies, CT scans.
• Evaluate and manage CROs and external technology vendors to meet company goals and CDM standards.
• Build and drive positive relationships and teamwork within the clinical team and partnering sites with professional demeanor.
• Make decisions and chart course through careful evaluation of risks and benefits with limited information in conjunction with leadership; serve 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’ industry experience in CDM in all study phases and activities from startup to archival with at least 5 years in a lead role for clinical development programs with medical devices leading toward FDA filing/approvals.
• Thorough knowledge of the CDM standards for medical devices (Class III PMA devices preferred).
• Expertise in development, validation, and management of the clinical study database throughout its life cycle, from CRF design, database development and testing, discrepancy management, data quality review and database close and lock procedures, CDASH and SDTM data formats.
• Working knowledge of the GCP, ICH and FDA guidance and regulations for clinical trials.
• Working knowledge of the MedDRA and WHODrug dictionary coding terms; able to complete tasks independently, accurately and efficiently with attention to detail and in a timely manner.
• Experience in implementing, validating, and administrating other clinical systems for data collection (e.g., eSource, IVRS, IWRS, core lab web‑based portals).
• Demonstrated ability to manage complex projects with tight timelines and overcome project roadblocks.

Seniority level

• Mid‑Senior level

Employment type

• Contract

Job function

• Information Technology

Industries

• Pharmaceutical Manufacturing