Job Description

• Location: Onsite; Boston, MA
• Interview process: 1-2 virtual interviews & a final onsite meeting with partner & client.
• Status: 1099, 12 month contract with the potential to transition into a full-time role with benefits.
• Work setup: Some on-site presence may be needed initially, but we anticipate much of the work can be done remotely.
• Pay rate: $65-85/hr with quarterly performance-based bonuses.
  
  

AKT Health Inc. was founded in 2017 in Japan and India by a team of Techno-functional experts in the Clinical, Medical, and Commercial fields, and has grown to over 100 team members in 18 countries, with 100+ Life/Sci/Pharma clients and 118 projects delivered.

As a Clinical and Medical partner with life science companies and health systems, AKT Health focuses on developing market-leading strategies for long-term top performance, engagement, growth, and sustainability. The company's philosophy of Applied Knowledge & Technology in Healthcare is reflected in its Expert Solutions in Consulting, Technology, and Intelligence, tailored to address the needs of Pharmaceutical, Medical Device, and Biotechnology firms.

Role Description

This is a full-time on-site role for a Senior Clinical Data Manager with 10+ years of experience at AKT Health Inc. located on-site in Boston, MA. The Clinical Data Manager will be responsible for managing and validating clinical data, utilizing Electronic Data Capture (EDC) systems, and overseeing all aspects of Clinical Data Management within the organization.

We’re seeking two CDMs with expertise in managing large-scale, Phase 3 clinical trials.

Key areas of experience include:

• Study initiation, monitoring, and closeout processes.
• Managing Electronic Data Capture (EDC) systems and regulatory compliance.
• Real-time data cleaning and discrepancy resolution.
• Cross-functional collaboration to ensure protocol adherence and data quality.
  
  

Responsibilities Include:

• Database Design and Setup.
• Data Collection and Quality Assurance.
• Discrepancy Management.
• Medical Coding and SAE Reconciliation.
• Interim Data Quality Reviews and Status Reporting.
• Collaboration and Communication.
  
  

Qualifications

• Data Management and Clinical Data Management skills.
• Data Validation and Electronic Data Capture (EDC) proficiency.
• Experience in handling and analyzing Clinical Data.
• Strong attention to detail and accuracy in data management.
• Knowledge of industry standards and regulations related to Clinical Data Management.
• Excellent organizational and time management skills.
• Ability to work effectively in a team environment and communicate with various stakeholders.
• Master's degree in a relevant field such as Life Sciences, Health Informatics, or a related discipline.
  
  

This is a Phase III clinical trial with up to 1,500 patients. There may be additional projects as part of the role.

Key requirements:

• Minimum of 10+ years of experience in Pharma Clinical Trials and Senior Data Management.
• Must currently reside in the Boston area.
• Open to 1099 status.