This individual will be responsible for executing specific capabilities within clinical trials, collaborating with operational and trial leads, and ensuring smooth logistics and distribution of global supplies. The ideal candidate will bring strong project management skills, the ability to collaborate cross-functionally, and a deep understanding of clinical trial operations.
Job Responsibilities:
Execution of Trial Capabilities: Partner with Operational and Trial Leads (e.g. Central Clinical Services, Mobile Research Community Enagagement, Kitting, Ancillaries) to execute trial-specific capabilities and ensure smooth trial progression.
Cross-functional Collaboration: Work closely with Clinical Design, Clinical Development, Clinical Lab Supply, Supply Planning, and Innovation Evidence teams to understand clinical program timelines, objectives, and requirements. Assist with the development of implementation strategies, forecasting, and budgeting.
Supplier Management: Collaborate with suppliers to monitor implementation status and resolve issues promptly to ensure successful execution of trial capabilities.
Logistics & Distribution: Proactively manage the distribution and logistics of global supplies, ensuring timely delivery to destinations (partners, depots, sites, and patients). Maintain and update dispensation plans for supplies as necessary.
Issue Resolution: Manage and resolve trial-level issues in a timely manner to maintain smooth trial operations and minimize disruptions.
Communication & Shared Learnings: Engage in ongoing communication with cross-functional business partners, sharing insights, progress, and challenges.
Metric Creation & Reporting: Support the creation and distribution of capability metrics, tracking key performance indicators related to trial delivery, implementation, budgets, and technology platforms.
Data Tracking & Collation: Track and collate data for reporting and metric purposes, including aspects related to budgets, logistics, and technology platforms.
Meeting Participation & Documentation: Actively participate in trial-level meetings (e.g., SDT meetings, Vendor meetings) and assist in reviewing meeting minutes and follow-up actions.
Process Documentation & Training: Lead the creation of job aids, process documentation, onboarding plans, operational plans, and RACI documents. Review and revise capability documents annually to ensure alignment with current practices and compliance.
Support RFPs & Inspection Readiness: Assist with RFP processes and ensure readiness for inspections, maintaining a high standard of trial preparedness.
Qualifications:
Bachelor's degree in Life Sciences, Business Administration, or a related field (or equivalent experience).
Proven experience in clinical trial operations or related roles within the pharmaceutical indsutry
Strong project management skills and the ability to manage multiple tasks simultaneously.
Excellent communication, collaboration, and problem-solving skills.
Experience with trial logistics, distribution, and supply chain management.
Familiarity with clinical trial management systems and tools (e.g., Vault Clinical, etc.).
Ability to analyze and track data, generate reports, and create metrics.
Experience with RFPs, vendor management, and inspection readiness.
Strong attention to detail and the ability to work in a fast-paced, dynamic environment.