Abarca Health

Senior Clinical Tria Coordinator

Verona, Veneto, Italy

Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Clinical Research, HealthcareIndustries

Requirements

Candidates should possess a Bachelor of Science degree in a scientific or health field and have previous experience in clinical research, preferably within CROs, Pharma, or academic/hospital settings. A strong understanding of ICH GCP, relevant regulations, and clinical research/regulatory/ethical requirements is necessary. Proficiency in English and MS Office Suite is also required, along with excellent organizational, multitasking, analytical, communication, and interpersonal skills.

Responsibilities

The Senior Clinical Trial Coordinator will ensure studies adhere to GCP, SOPs, protocols, budgets, and timelines, collaborating with the Study Start-Up team to ensure quality and timely completion of start-up activities. This role involves overseeing and mentoring junior coordinators, managing ethical and regulatory submissions, contract negotiations, ISF preparation, TMF setup, and maintenance. Responsibilities also include training junior staff, maintaining relationships with Ethics Committees and Competent Authorities, assisting with site/vendor invoicing and management, preparing project reports, updating CTMS, tracking study-specific information, supporting CRA activities, assisting with document translation, and participating in meetings and audits.

Skills

GCP
SOPs
Protocol Adherence
Budget Management
Timeline Management
Ethics Submission
Regulatory Submission
Contract Negotiation
ISF Preparation
TMF Setup
TMF Maintenance
CTMS
Vendor Management
Project Reporting
CRAs Activities Follow-up
Document Translation

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.

Land your dream remote job 3x faster with AI