Job Number: 19-07998
Job Number: 19-07998
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Business Analyst 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!
- The Clinical Trial Business Analyst, Electronic Data Capture (EDC) Capabilities role will provide overall leadership and governance of a GCO business capability end-to-end, encompassing process and technology strategy implementation. The BCL will be acting as the primary point of contact and advisor for the business capability stakeholders across GCO through proper stakeholder engagement and management. Success in that role will require ensuring proper demand management, prioritization and evaluating process impact assessments of key change initiatives ensuring value is delivered through the business capability. The role is also accountable for executing the business capability governance and process strategy including the use of technologies and related systems in support of clinical trial research programs. The role also ensures effective alignment of systems/technologies with other business processes and regulatory requirements for inspection readiness. Specifically, this BCL role will own the Electronic Data Capture capability, including technology systems and processes, and is accountable for compliance with key regulatory and quality requirements pertaining to the capability.
- Serves as the Business Capability Lead/Subject Matter Expert for the business capability, including system/technology, regulatory inspection/internal audit
- Key responsibilities are : 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 Contract Research Organizations (CROs)/vendors on strategy, development, implementation, and oversight of enhancement to current business capability
- 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
- 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 required with an advanced degree preferred. Minimum of 5 years of direct experience independently managing clinical trial (study, data, or system/technology) activities and 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 and Oracle Clinical
- Experience with Regulatory requirements with regards to the Clinical Data Management
- Understanding of challenges and opportunities in managing data within 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
- 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:
Melrose Madrigal | 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.
Job Status: Contract/Temporary