Senior Data Manager at Abarca Health

Verona, Veneto, Italy

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Clinical ResearchIndustries

Requirements

Experience in data management for clinical studies, particularly in leading DM tasks on time and within budget
Ability to partner with Sponsors, clinical teams, and statistics to develop data collection specifications from all data sources
Proficiency in managing in-stream data flow activities and delivering quality databases in accordance with project plans
Leadership skills to lead and drive DM teams and act as the reference point for Sponsors and project leads from a data management perspective
Knowledge of industry standards like ICH, GCP, SOPs, and guidance documents
Experience with EDC studies, including User Acceptance Testing (UAT) and eCRF management
Skills in SAS listings or SAS checks for database validation
Familiarity with term coding, query management, data integration, and reconciliation of external data (e.g., SAE, Central Labs, ECGs)
Ability to train staff, prepare guidelines (CRF completion, data-entry), and execute QC plans
Strong communication and networking skills within study teams

Responsibilities

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 (CRF) 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
Validate the database and computerized checks, including SAS listings or SAS checks
For EDC studies, define the User Acceptance Test Plan (UAT) and execute test activities in the test environment to ensure quality eCRF
For EDC studies, provide 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 and raise manual queries for uncoded terms as required
Manage queries: review discrepancies, review answered queries, resolve and close where appropriate, manage 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)
Run and monitor study data progress reports including query management and take appropriate actions (e.g., escalation, re-training)
Escalate any study issues within the 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; monitor progress of activities
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, guidance documents, and applicable industry standards like ICH, GCP in 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
Maintain continuous and appropriate communication with stakeholders

Skills

SAS

Clinical Data Management

CRF Design

Data Validation

Database Validation

Data Management Plan

Data Validation Plan

Reconciliation Plan

Database Lock

Abarca Health

Pharmacy Benefit Management services provider

About Abarca Health

Abarca Health provides Pharmacy Benefit Management (PBM) services, focusing on flexible and user-friendly solutions for health plans, employers, and government programs like Medicare and Medicaid. Its main product, the Darwin platform, allows clients to quickly implement and modify benefit designs while ensuring compliance with regulations. Abarca Health manages over $5.3 billion in drug spend and processes 100 million prescription claims annually, offering additional services like home delivery for prescriptions. The company's goal is to deliver exceptional service and innovative solutions in the PBM market.

Aventura, FloridaHeadquarters

2005Year Founded

VENTURE_UNKNOWNCompany Stage

HealthcareIndustries

501-1,000Employees

Benefits

PTO

Parental leave

Work flexibility

Health insurance

Wellness stipend

401k

Tuition reimbursement

Leadership development programs

Risks

Increased competition from Amazon Pharmacy and Mark Cuban's Cost Plus Drug Company.

Growing focus on specialty drugs may require platform adaptation.

Shift towards price transparency could pressure Abarca's pricing models.

Differentiation

Abarca Health's Darwin platform is highly adaptable and user-friendly.

The company offers innovative programs like Triple S en Casa for home delivery.

Abarca Health ensures compliance with ever-changing healthcare regulations.

Upsides

Abarca transitioned two million members to Darwin in 18 months, showing operational efficiency.

Collaboration with Blue Shield of California boosts Abarca's reputation in the PBM sector.

Recognition as a top IT workplace attracts top talent, driving innovation.

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