Principal, Data Manager

Europe-Remote

Full Time Senior-level / Expert EUR 48K - 90K *

Alira Health

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Posted 18 hours ago

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

The Principal Data Manager ensures DM tasks for the assigned studies are performed on time and within budget, partners with Sponsors, clinical and statistics to develop the data collection specification from all data sources
The Senior Data Manager manages in-stream data flow activities and deliver a quality database in accordance with the project plan, leads and drive the DM team, and acts as the reference point for the Sponsor and the appointed person responsible for the project from the data management perspective.

Job Description

ROLE

The Principal Data Manager leads and drives the DM team, acting as mentor and coach and as the reference point for the Sponsor and the appointed person responsible for the project from the Data Management perspective, to develop the data collection specification from all data sources

The Principal Data Manager manages in-stream data flow activities and deliver a quality database in accordance with the project plan, ensures DM tasks for the assigned studies are performed on time and within budget, makes recommendation for process improvement and/or new standards development.

The Principal Data Manager is an effective input into strategic planning across the department and bridges scientific or medical knowledge to data management processes to ensure sound data collection tools, validations and integration to fit for purpose clinical datasets.

KEY RESPONSABILITIES

Accountable for driving achievement 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
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 executive 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 proritising
Input into and monitor progress against study project plan and escalate issues to resolution at the appropriate level
Proven ability to analyse data capture problems/opportunities and a track record of developing and delivering high quality solutions
Demonstrate broad and integrated knowledge of all aspects of Data Management providing consultancy to other groups outside CDM
Educate/train on use of study specific data collection tool(s) and query management process
Effectively contribute in formal training for new starters
Make recommendations for process improvements and development of new standards
Maintain continuous and appropriate communication with sponsors and share with them critical and general issues
Effective relationship management with vendors and customers in order to meet expectations and achieve results
Effectively represents Data Management in internal or external meetings (e.g. Investigator’s Meetings)
Conducts other activities as required

DESIRED QUALIFICATION & EXPERIENCE

Degree in life science, pharmaceutical, biology or related field or at least 6 years’ experience in data management field or similar in a pharmaceutical environment or equivalent
Knowledge of Data Management processes, Very Good
Knowledge of pharmaceutical industry guidelines like ICH, GCP etc, Very Good
Expert in one or more DM systems or processes and recognized for their expertise
Able to propose standards across studies and therapeutic areas
Proficiency in Medidata Rave or Merative Zelta
Oncology experience