Job Description

Clinical Data Manager
Job Number: 19-04622
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Clinical Data Manager for our client in Pennington, NJ
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
Position Overview:
  • The Business Lead role will provide overall leadership of system/technology projects (End-to-End process) acting as the primary point of contact and advisor for the business users of the system
  • Accountable for business process strategy and use of data technologies and related systems in support of clinical trial research programs
  • Ensures effective alignment of systems/technologies with other business processes and regulatory requirements for inspection readiness.
 
Responsibilities:
  • Serves as the Business Lead/Subject Matter Expert for the system/technology including point of contact for regulatory inspection/internal audit.
  • Drives development, execution, and monitoring of the system/technology Business Plan in collaboration with key stakeholders.
  • Partners with R&D functions, internal and external partners including Contract Research Organizations (CROs)/vendors on strategy, development, implementation, and oversight of new and existing platform capabilities.
  • Accountable for system/technology performance, project budget, stakeholder communications/change management, resolution/mitigation of issues and risks.
  • Oversees system/technology work streams and outcomes.
  • Contributes to internal/external continuous improvement initiatives.
  • Monitors new technologies and external trends to ensure Client is leveraging the best of what is available
 
Qualifications:
  • Bachelor’s degree required with an advanced degree preferred. Minimum of 8 years of direct experience independently leading and managing clinical trial (study, data, or system/technology) activities plus 1-2 years in a leadership position directing system, process, program or quality activities. Significant, demonstrated breadth of experience, versatility, and independent leadership and stakeholder management skills.
  • Experience in clinical trial, data, or technology management
  • Knowledge of GCP/ICH guidelines, regulations
  • Experience with Electronic Data Capture practices and principles
  • Experience with Medidata RAVE and Oracle Clinical technologies
  • Ability to analyze and interpret complex issues and propose innovative solutions
  • Strong project management and planning skills
  • Effective oral and written communication skills to influence, inform, or guide others
  • Ability to effectively respond to regulatory trends, internal audits, inspection activities including root cause analysis/Corrective Action/Preventive Action (CAPA) plans for any findings.
  • Experience working in a matrix environment.
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
Antonette Dizon              
cerina.dizon@eclaro.com            
6466800169

Antonette Dizon | LinkedIn
 
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

 

Application Instructions

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