Manage and may lead the day-to-day operations within relevant support function to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g., study teams) to support timely completion of both drug and non-drug program goals and objectives
Manage and may lead functional and cross-functional internal teams
Provide accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools
Proactively identify and escalate issues that arise related to support functional deliverables
Responsible for implementation of standards for designated functional areas
Responsible for the management of functional budgets and resources (where appropriate) and management of related components of trial or support function budgets, timelines and resources. May also provide oversight for these activities.
Qualifications
BA/BS degree with ≥3 years of experience in pharmaceutical related drug development or direct equivalent experience
Must have knowledge of clinical trial conduct, including, multi-center, global trials.
Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
Requires proven project management skills and leadership ability
Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
