Job Description

Operations Specialist
Job Number: 21-05358
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for an Operations Specialist for our client in Lawrenceville, 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!

  • Serves as the Business Capability Lead/Subject Matter Expert for the business capability, including system/technology, regulatory inspection/internal audit
  • Leads development of a connected experience for Data Management stakeholders, investigators and site staff to support Clinical Data Capture best practices before, during and after trial completion
  • Effectively managing and engaging key stakeholders as per governance strategy to ensure business needs and requirements are met, prioritized and communicated
  • Serve as the SME of for hCelgene RAVE EDC Study build, amendments, data extracts, reporting and new regulation impact assessments
  • Serve as the SME for data interfaces between hCelgene Rave EDC system and other internal/ external solutions
  • Point of escalation for team that performs tactical work in the system such as timely access provisioning, de-provisioning and periodic access reviews
  • Perform configuration changes and provide overall support for system
  • Coordinate issue analysis, resolution and technology upgrades with vendor
  • Performs process impact assessments as needed to determine breadth and risks involved with proposed change initiatives
  • Ensures proper documentation and oversight of all business processes, standard procedures and technical instructions related to business capability ensuring compliance with regulatory requirements
  • Implement operational support model and training delivery plan to support the evolving needs from a business process and system life-cycle management perspective
  • Partners with IT drive a clear roadmap for the business capability that includes proper demand management, release planning and release management of technology system(s)
  • Partners with R&D functions, internal and external partners including Contract Research Organizations (CROs)/vendors on strategy, development, implementation, and oversight of enhancement to current business capability
  • Works broadly across Global Clinical Operations, Global Clinical Development, Global Data Management, Centralized Monitoring, Regional Clinical Operations, Clinical Trial Strategy, Quality & Compliance, and IT to leverage digital expertise and capabilities across the enterprise
  • 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 and oversees business capability operational health and metrics, including review of open tickets/requests and timely resolution
  • Embraces a culture of quality, compliance and data integrity to promote a state of inspection readiness for the business capability
  • Participate in audits and inspections for the business capability to ensure data requests by auditors and agencies are met
Required 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 (EDC) best practices and principles including Medidata RAVE EDC, including several modules in those platforms to support data capture, safety reporting, central monitoring, and clinical data reporting
  • Experience with Regulatory and Compliance requirements with regards to the Clinical Data Management
  • Understanding of challenges and opportunities in managing data within clinical trials
  • Understanding of Clinical Data Management and Clinical Development stakeholder needs, challenges and opportunities in clinical trials
  • Experience working with global teams in different geographies with a diverse set of perspectives in different regulatory contexts
  • Ability to analyze and interpret complex issues and propose innovative solutions
  • 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 matrixed 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:
John Bayog
John Bayog | 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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