Job Description

JOB DESCRIPTION
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.

Job Tags

Permanent employment,

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Principal Clinical Data Manager Job at Cytel - EMEA, Cambridge, MA

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