Senior Clinical Data Manager

JOB SUMMARY: 

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 portions of a project
with no supervision or a full project with minimal supervision.

JOB RESPONSIBILITIES:

• Adherence to SOPs and maintaining audit-ready documentation.
• Coordinate data management activities, ensuring high quality, respecting project
timelines and adherence to the budget for a full project or dedicated part of a
project.
• 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 and notify the appropriate
personnel.
• If acting as Lead Clinical Data Manager, 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.
• If acting as Lead Clinical Data Manager, 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.
• Assist with evaluating data management needs and propose appropriate, innovative,
and efficient data management solutions.
• Participate in writing departmental procedures and guidelines.
• Train and mentor less experienced staff.

QUALIFICATIONS:

Education: Bachelor’s degree in Life Sciences, Computer Science or related discipline.
Experience: A minimum of five years of progressive experience in Clinical Data Management
or Clinical Research
Skills:
• Proficient in at least one of the prevalent EDC tools (Medidata Rave, Merative Zelta,
Medrio, VieDoc, Oracle InForm).
• Strong 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.
• Good knowledge of data, databases, and data procedures.
• Working knowledge of CDISC standards for data management.
• Proficient with Microsoft Office Suite (Excel, Word, PowerPoint).
• Good verbal and written communication.
• Flexibility, proactivity, and ability to work independently and in a team environment.
• Detail-oriented with analytical mind-set.
• Good problem-solving skills.
• Project management and negotiation skills.