Operations SpecialistBe part of a company that delivers life-changing healthcare solutions. Eclaro is looking for an Operations Specialist for our client in Lawrence Township, NJ.
Job Number: 21-05747
Job Number: 21-05747
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 digital experience for external investigators through the ISR process.
- Owns the governance strategy, roadmap, execution, and monitoring of the business capability.
- Effectively managing and engaging key stakeholders as per governance strategy to ensure business needs and requirements are met, prioritized and communicated.
- 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.
- Develop and 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 to set and 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 vendors on strategy, development, implementation, and oversight of enhancement to current business capability
- Works broadly across Global Development Operations, Regional Clinical Operations teams, Protocol Management teams, Field Medical teams, Commercial, IT, Public Affairs and Legal to leverage digital expertise and capabilities across the enterprise.
- Accountable for system/technology performance, platform, integrations, 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
- Monitors and oversees business capability operational health and metrics
- 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
- Bachelor's degree
- Minimum of 8 years of direct experience independently leading and managing clinical trial (study, data, or system/technology) activities
- 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 Investigator Sponsored Research (ISR), Expanded Access, Compassionate Use and Named Patient Program (NPP) practices and principles
- Experience with Regulatory requirements with regards to Investigator Sponsored Research and associated capabilities
- Understanding of ISR, Expanded Access, Compassionate Use and NPP needs, challenges and opportunities in clinical research
- Experience working with global teams in different geographies with a diverse set of perspectives in different regulatory contexts
- Knowledge of Veeva Vault and Salesforce.com capabilities
- Ability to analyze and interpret complex issues and propose innovative solutions
- Experience with leading teams and driving innovation
- 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:
Jay Lucas | 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.