Consultant Senior Data Manager

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

Job Description

ROLE

The Consultant Senior Data Manager will work with a Pharma Client and support the implementation of a phase 3 study in a rare disease indication as well the implementation of a safety study. The build of the eCRF will be performed by Veeva

The data manager will be responsible to author all the data management documents like CRF design, DMP, Data Validation Plan, validate the eCRF, perform UAT, query management, data review, lock and freeze, all data management activities from start-up to closure.

The data manager will use the sponsor’s Veeva system and sponsor’s SOP

The study will include IRT in Veeva and ePRO (build done by Veeva) as well as upload onto Veeva of imaging data and the Data Manager will be responsible to support these tasks and ensure they are implemented correctly and within timelines.

KEY RESPONSABILITIES ​

• 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

DESIRED QUALIFICATION & EXPERIENCE 

• Degree in life science, pharmaceutical, biology or related field or at least 6-8 years’ experience in data management field or similar in a pharmaceutical environment or equivalent 

• Knowledge of Data Management processes, Good 

• Knowledge of pharmaceutical industry guidelines like ICH, GCP etc, Good 

• Knowledge of coding dictionaries like MedDRA and WHO-DD or equivalent, Good 

• Knowledge in one or more DM systems, Good 

• Veeva CRF proficiency

• Candidate needs to live in Europe

Languages

English

Education

Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Pharmacy

Contract Type

Contingency Workforce