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.
· 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.
Education: Bachelor’s degree in Life Sciences, Computer Science or related discipline.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.
Experience: A minimum of five years of progressive experience in Clinical Data ManagementEducation: 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.
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.
