Principal Clinical Data Manager

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.

Cytel Confidential: This is a controlled document and shall not be changed, saved, copied or reproduced by any
unauthorized person.
• 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.

QUALIFICATIONS:

Education: Bachelor’s degree in Life Sciences, Computer Science or related discipline.
Experience: A minimum of eight years of progressive hands-on experience in Clinical Data
Management or Clinical Research.
Skills:
• Proficiency in at least one of the prevalent EDC tools (Medidata Rave, Merative Zelta,
Medrio, VieDoc, Oracle InForm).
• Advanced knowledge of the pharmaceutical industry including understanding of
clinical drug development process and associated documents (SOPs/Guidelines/Work
Instructions).
• Knowledge of ICH-GCP and any other applicable local and international regulations
such as 21 CFR Part 11.
• Strong knowledge of data, databases and data procedures.
• Working knowledge of CDISC standards for data management.
• Proficient with Microsoft Office Suite (Excel, Word, PowerPoint).
• Excellent verbal and written communication.
• Flexibility, proactivity, and ability to work independently and in a team environment.
• Detail-oriented with analytical mind-set.
• Excellent problem-solving skills.
• Project management and negotiation skills.
• Strong leadership and mentoring skills.