Consultant Senior Data Manager

Accountable for driving achievements of project milestones from study start up through to delivery of database 

Provide Data Management input into the protocol 

Design the Case Record Form and guide process for CRF approval 

Define and develop the Data Management Plan, Data Validation Plan and their annexes (e.g. Reconciliation Plan), with input from the study team

Validation of the database and computerized checks, including SAS listings or SAS checks

Validation of the database and computerized checks, including SAS listings or SAS checks 

For EDC studies, define the User Acceptance Test Plan (UAT) and execute the test activities in the test environment to ensure quality eCRF 

For EDC studies timely response to issues identified by the eCRF Helpdesk 

Prepare CRF completion guidelines 

Prepare study specific data-entry guidelines and train data-entry staff 

Perform term coding for clinical studies, raise manual queries for uncoded terms as required 

Query management: review discrepancies, review answered queries, resolve and close where appropriate, manage the data cleaning process including manual checks and Medical Review listings 

Create and test import programs for electronic data received from external vendors 

Perform timely data integration of CRF and non CRF data (data import from external sources) 

Perform reconciliation of external data (e.g. SAE, Central Labs, ECGs, etc) 

Run and monitor study data progress reports including query management and take appropriate actions (e.g. escalation, re-training, etc), escalate any study issues within study team 

Define and execute QC plan, lead and execute database release and database freeze activities 

Lead the DM team, coordinate other DM staff providing direction regarding work assignment, scheduling and prioritizing 

Input into and monitor progress against study project plan and escalate issues to resolution at the appropriate level 

Effectively contribute in formal training for new starters 

Demonstrate good application of document management process and procedures 

Follow SOPs and guidance documents as well as applicable industry standards like ICH, GCP etc to day-to-day activities 

Make recommendations for process improvements and development of new standards 

Develop and maintain a network of contacts within the study team 

Lead the DM team, coordinate other DM staff providing direction regarding work assignment, scheduling and prioritizing; monitor progress of activities 

Maintain continuous and appropriate communication with sponsor and share with them critical and general issues 

Effectively represents Data Management in internal or external meetings (e.g. Investigator’s Meetings) 

Conduct other activities as required