Lead- MICC

About Navitas Life Sciences:

Navitas Life Sciences is a technology-backed global clinical research organization, headquartered in Princeton, NJ, with over 1000 employees and spread across 5 countries.

At Navitas Life Sciences, we are committed to accelerate time to market for life-saving therapies. We are a technology driven CRO with end-to-end and point services and solutions for drug development and beyond. We provide outsourced data science, regulatory & safety, and full-service CRO services to large and mid-sized biopharmaceutical clients. Navitas Clinical Research provides full service CRO offerings to global biopharma companies. Navitas Data Sciences is our global clinical data functional service provider.

Our functional service expertise optimizes the clinical trial process, drives cost efficiencies for our clients, and ensures adherence to regulatory compliance requirements. Navitas Life Sciences industry-focused consulting services enable our clients to build innovative and sustainable processes, systems & organizations. For over 20 years our industry-leading networks bring together top companies worldwide and shape the future of the industry.

Navitas Life Sciences is proud to be an HIG Portfolio company.

Website: www.navitaslifesciences.com

Responsibilities & functions: MICC

• Efficiently manage MICC service lines
• Have complete oversight on assigned MICC projects
• Apply knowledge & expertise for project progress
• Coordinate with projects Leads & external stakeholders
• Active involvement in Business Development and new Proposals
• All the following responsibilities and functions are undertaken in line with Navitas Life Sciences (NLS) current Standard Operating Procedures (SOPs), Policies and ICH-GCP. The duties and responsibilities listed below are representative of the nature and level of work assigned and are not necessarily all-inclusive:
• Manage MICC services for Clients across the Globe
• Ensure adequate levels of available capacity & capabilities for MICC services.
• Build and improvise MICC process and develop.
• Manage Delivery, resource utilization, and People management.
• Manage resources in such a way that agreed delivery performance (cost, compliance, quality, SLA, KPIs/CTS, employee satisfaction, trend analysis) can be maintained at all the times.
• Participate in Workflow, Operational/any client specific or other stakeholder meetings.
• Review Deviations & CAPA for respective errors and ensure preventive measure are in place. • Provide project specific performance feedback to the management and escalate issues in a timely manner.
• Provide all delivery related risks, issues, and client specific issues/escalations to the management team.
• Provides oversight and guidance on organizational goals and company objectives Monitoring the quality of work and efficiency of team members with contracted scope of work and Safety Management Plan & MICC Data Entry Specification.
• Participate/Support in Audits and responsible for closing CAPAs on time.
• Manage other workflows as needed
• MICC subject matter expert- Experience in Medical Information Contact Centre (MICC) to support services for Clients across the Globe

Other Responsibilities

• Read and acknowledge all necessary NLS and Sponsors standard operating procedures as required.
• Participation in local or global project teams, including on-time delivery of assigned responsibilities.
• Collaborate in the development, review, and initiation of SOPs.
• Interacts with staff in other functional areas within the company to ensure the highest level of client satisfaction through successful execution of projects.
• Support oversight on operational activities and sound understanding on project plans/documents.
• Participate in team meetings and provide regular feedback to the management on operational metrics and other challenges/issues.
• Participate in trainings offered by NLS and sponsors and contribute to identification and implementation of process efficiencies.
• Liaise with managers and in proactively identifying issues and proposing solutions.
• Providing technical reports, metrics, invoices, and support on new initiatives Delegating client requests and ensure it is addressed within the timelines.
• Perform MICC agent activities, if needed
• Always exhibits a detail-oriented etiquette and friendly attitude when answering telephone calls.