Hybrid Sr. Data Manager or Principal Data Manager Sr. Data Manager or Principal Data Manager with verification

JOB SUMMARY: Coordinate and perform data management tasks from study start up

through database lock, including database set-up and data validation as per the requirements

in the clinical protocols and ensure timely delivery of high-quality consistent data. Lead all

portions of a project/and or multiple projects with minimal or no supervision.

Job Responsibilities

• Adherence to SOPs and maintaining audit-ready documentation.
• Coordinate and oversee activities of all DM staff assigned to the project, ensuring
  
  

high quality, respecting project timelines and adherence to the budget.

• Attend relevant project meetings and work closely with other internal and external
  
  

leads.

• Liaise with client/partners for clarification on any clinical and / or technical decisions
  
  

and propose most efficient solutions.

• Identify risks to project deliverables and timelines, develop and implement the
  
  

mitigations for these risks.

• Create DM timelines for database set-up.
• Lead and participate in the design of Clinical Electronic Data Capture (EDC)
  
  

components including mock CRF, casebook, edit checks.

• Coordinate and create data management documentation including Data Management
  
  

Plan, Data Validations Specifications, eCRF Completion Guidelines, Data Collection

System Configuration, Data Transfer Agreement.

• Coordinate and perform User Acceptance Testing.
• Train EDC users.
• Manage EDC users’ access and assist with resolving issues.
• Coordinate all conduct Data Management tasks.
• Lead and participate in data cleaning activities including SAE and external data
  
  

reconciliation.

• Provide input to protocol and assess database impacts based on protocol changes
  
  

during study lifecycle; prepare and execute change request forms.

• Lead and participate in Database Lock activities, including timelines creation, QC
  
  

coordination and Data Management Report creation.

• Contribute to departmental procedures and guidelines.
• Critically evaluate data management needs and propose appropriate, innovative, and
  
  

efficient data management solutions.

• Train and mentor less experienced staff.
• Represent Cytel at project, proposal, or industry meetings.
• May participate in the recruitment process.
• Contribute to budget evaluation for proposal writing purpose and be Data
  
  

Management representative during bid-defense, as needed.

• Support senior team members and/ or be the data management representative
  
  

during audits.

• May act as a line manager, contribute to the development of a strong team of data
  
  

managers, by functionally managing and guiding the data managers with respect to

data management strategy, deliverables, processes, and professional development.