Manager / Sr. Manager, Clinical Data Management

2 weeks ago

Waltham, United States Q32 Bio Inc. Full time

General Scope and Summary

Q32 Bio is searching for a Clinical Data Manager/Sr. Manager responsible for timely and high-quality data management/analytics deliverables. Our Clinical Data Manager/Sr. Manager will also be responsible for leading or contributing to company process improvement initiatives, vendor performance assessments and governance of clinical data standards.


This position will report to our VP, Clinical.


Role and Responsibilities

  • Provides clinical data management leadership within the study team(s) to align objectives and drive data collection requirements for multiple clinical trials.
  • Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner.
  • Responsible for end-to-end clinical data management/analytics activities and serves as a primary point of contact for internal/external study team members and stakeholders.
  • Provides strong quality and project oversight over third party vendor(s) responsible for data management/analytics deliverables.
  • Gathers content and integration requirements for EDC and ensures close collaboration / alignment with partners supporting other data collection systems (eCOA, Lab Transfers, IRT, etc.).
  • Enforces data standard conventions and ensures high quality expectations for all clinical data per defined processes & best industry practices.
  • Authors, reviews/revises clinical data management related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines and other study documents to ensure quality and standardization.
  • Leads Data Review meetings with cross functional study team members to ensure on-going review of trial data currency, quality, and completeness.
  • Represents Data Management on cross-functional clinical development team.
  • Leads or supports Health Authority inspections and audits as relates to Data Management activities.
  • Acts as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities including Statistical and Clinical Programming.
  • Manages data currency throughout the trial, and responsible for overall monitoring of data management deliverables.
  • Defines, manages, and governs clinical data standards in accordance with CDASH principles and best practices.


Qualifications

  • Minimum Bachelors in pharmacy, biology, drug development or related field from an undergraduate program required; preferred graduate level study in similar fields.
  • Ability to work from the Company’s Waltham, MA office 3 days per week
  • 6+ years of experience in clinical data management gained from working at recognized clinical data management suppliers/vendors, reputable CRO(s) and/or a Sponsor environment working on multi-phase, multi-therapeutic and diverse clinical trials from study initiation to completion.
  • Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors.
  • Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
  • Sound knowledge of Clinical Drug Development Process, FDA/ICH guidelines and industry standard practices regarding data management.
  • Strong knowledge and experience of EDC systems; demonstrated knowledge of Microsoft Office skills and well versed in industry trends and emerging technologies supporting data collection.
  • Experience managing non-EDC data sourced from laboratories, eCOA and IRT.
  • Experience managing and collaborating with Statistical and Clinical Programming vendors to meet project needs.
  • Strong project management; exhibits expertise in metrics analysis and reporting methodologies.
  • Good understanding of coding (MedDRA, WHO drug dictionaries).
  • Excellent oral and written communication skills, with all stakeholder levels.
  • Deep knowledge of CDASH/CDISC (CDASH CRF Library implementation experience is preferred).
  • Knowledge of submission requirements, [e.g., New Drug Application (NDA)/Biologics License Application (BLA)/Market Authorization Application (MAA)].
  • Flexibility to travel as needed

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