Principal, Data Manager

Alira Health - Boston, MA

Full-time - Senior

Boston, MA

Professional, Scientific, and Technical Services

About the position

The Principal Data Manager is responsible for overseeing data management tasks for assigned studies, ensuring they are completed on time and within budget. This role involves collaboration with sponsors, clinical teams, and statistics to develop data collection specifications and manage data flow activities. The Principal Data Manager leads the data management team, acts as a mentor, and serves as the primary contact for sponsors regarding data management processes, ensuring high-quality database delivery and strategic input across the department.

Responsibilities

• Accountable for driving achievement of project milestones from study start-up through to delivery of the database.
• Provide Data Management input into the protocol.
• Design the Case Record Form and guide the process for CRF approval.
• Define and develop the Data Management Plan, Data Validation Plan, and their annexes with input from the study team.
• Validate the database and computerized checks, including SAS listings or SAS checks.
• For EDC studies, define the User Acceptance Test Plan (UAT) and execute test activities in the test environment to ensure quality eCRF.
• Prepare CRF completion guidelines and study-specific data-entry guidelines, and train data-entry staff.
• Perform term coding for clinical studies and raise manual queries for uncoded terms as required.
• Manage query discrepancies, review answered queries, resolve and close where appropriate, and manage the data cleaning process.
• Create and test import programs for electronic data received from external vendors.
• Perform timely data integration of CRF and non-CRF data from external sources.
• Run and monitor study data progress reports including query management and take appropriate actions.
• Define and execute QC plan, lead and execute database release and freeze activities.
• Lead the DM team, coordinate other DM staff, and provide direction regarding work assignments and scheduling.
• Input into and monitor progress against the study project plan and escalate issues to resolution.

Requirements

• Degree in life science, pharmaceutical, biology, or related field or at least 6 years' experience in data management field or similar in a pharmaceutical environment.
• Knowledge of Data Management processes and pharmaceutical industry guidelines like ICH, GCP.
• Expertise in one or more DM systems or processes and recognized for their expertise.
• Proficiency in Medidata Rave or Merative Zelta.

Nice-to-haves

• Oncology experience
• Proficiency in MS Office Suite
• Commercial and Technical Writing Skills

Benefits

• Full-time position
• Opportunity for professional development
• Collaborative work environment