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Alira Health · 4 hours ago

Senior/Principal Data Manager

United States

Full-time

Remote

Senior Level, Lead/Staff

3+ years exp

Alira Health is a global team dedicated to innovation and initiative, where collaboration is encouraged across different time zones. The Senior Data Manager is responsible for ensuring data management tasks are performed on time and within budget, managing data flow activities, and leading the data management team while acting as the primary contact for sponsors regarding data management aspects.

BiotechnologyConsultingHealth Care

Responsibilities

Recent experience in using Medrio as Study Data Manager

Recent experience of building eCRFs using Medrio

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

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

Qualification

MedrioData Management PlanSASECRF buildingData Validation PlanICH guidelinesGCP guidelinesMedDRAWHO-DDMS Office SuiteLearning AgilityEffective Verbal CommunicationProblem Solving SkillsTeam Player

Required