Senior Clinical Data Manager/Principal Clinical Data Manager

Senior Clinical Data Manager/Principal Clinical Data Manager

Remote, Canada

*This position is 100% remote, but the preference is to have someone on the east coast*

Position Summary:
The Senior Clinical Data Manager/Principal Clinical Data Manager is responsible for managing all aspects of the clinical trial data management process from study start-up to post-database lock for assigned projects. Standard Operating Procedures / Work Instructions (SOPs/WIs), regulatory directives, study-specific plans, and guidelines will be followed. This position will also oversee and/or perform database development and testing.

Essential functions of the job include but are not limited to:

• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s)/program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member.
• Oversee project data entry process including development of data entry guidelines, training, data entry quality, and resourcing.
• May perform quality control of data entry.
• Provide input, assess and manage timelines. Ensure that clinical data management deadlines are met with quality.
• Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders.
• May assist in building clinical databases.
• Conduct database build UAT and maintain quality controlled database build documentation.
• Responsible for creating, revising, and maintaining data management documentation.
• Train clinical research personnel on the study-specific CRF, EDC, and other project-related items as needed.
• Review and query clinical trial data according to the Data Management Plan.
• Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM.
• Run patient and study level status and metric reporting.
• Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency.
• Liaises with third-party vendors in a project-manager capacity in support of timelines and data-related deliverables.
• Identify and troubleshoot operational problems based on metrics data, audit reports, and input from project team members.
• Participate in the development and maintenance of Standard Operating Procedures (SOPs) related to data management and database management activities.
• Provide leadership for cross-functional initiatives, where applicable.
• Train and ensure that all data management project team members have been sufficiently trained.
• Communicate with study sponsors, vendors, and project teams as needed regarding data, database, or other relevant project issues.
• May require some travel.
• Perform other duties as assigned.

Qualifications:
Minimum Required:

• Bachelors and/or a combination of related experience.

Other Required:

• 8+ years’ experience for a Sr. Clinical Data Manager and 10+ years for a Principal Clinical Data Manager.
• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
• Excellent organizational and communication skills.
• Experience in utilizing various clinical database management systems.
• Broad knowledge of drug, device, and/or biologic development and effective data management practices.

Preferred:

• Experience in a clinical, scientific, or healthcare discipline.
• Dictionary medical coding (MedDRA and WHODrug).
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.).
• Oncology and/or Orphan Drug therapeutic experience.