Job Description

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
drugdevelopmentprocessandassociateddocuments(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
drugdevelopmentprocessandassociateddocuments(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.