Astellas Pharma Senior Manager Clinical Science Center of Excellence (Clinical Compliance) in Northbrook, Illinois
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Senior Manager Clinical Science Center of Excellence (Clinical Compliance) opportunity in Northbrook, IL.
Position & Scope:
This Clinical Science position is responsible for Quality and Compliance activities. This role will be focused on assisting study teams with Clinical Compliance and Risk Based Monitoring (RBM). This position will be accountable for facilitating risk assessments and supporting teams with audit and inspection readiness activities as well as process improvement projects to address quality and compliance issues.
Essential Job Responsibilities:
- Manage and 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 lead related functional and cross-functional teams (including external service providers)
- Provide accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools
- Proactively identify and resolve issues that arise related to support function deliverables
Accountable for all activities related to the relevant support function. This may include:
Manage and Provide operational support in the creation, implementation, maintenance and optimization of patient centered approaches for clinical trials inclusive of Clinical Science approaches to Decentralized trials and/or
- Manage Clinical Science Compliance related activities inclusive of holistic evaluation of CS related audit findings, execution of CAPA and process related effectiveness checks, and CS inspection readiness support and/or
- Manage Clinical Science Vendor oversight/performance activities inclusive of vendor capability evaluation & selection, management of assigned vendors, planning/delivery of vendor governance meetings, analysis of key performance measures, vendor issue escalation etc. and/or
- Manage and provide operational support of the global study operating model inclusive of development and maintenance/optimization of various CS business processes and service provider related operating models (CRO, IRT, Central Lab) and/or
- Manage the sustainability and optimization of the CRO/Sponsor Partnership processes for Clinical Science and/or
- Manage and provide operational support related to technology and data enablement for the CS organization and/or
Management of CS QD changes and training related assignments/curriculum
Participate in process improvement and quality-related initiatives associated with study execution and deliverables
- Provide oversight and direction to team members for functional and study-related deliverables
Responsible for the preparation and management of functional budgets and resources (where appropriate) and oversight of related components of trial or support function budgets, timelines and resources.
Reports to the Associate Director, Clinical Science or above. This position may have direct reports (no more than 2) and provides oversight and direction to team members for deliverables and may provide direct supervision for contract team members.
- BA/BS degree with at least 7 years of experience (or 5 years direct experience with an advanced degree (MS/PhD/PharmD)) in pharmaceutical drug development, direct clinical trial management experience is strongly desired;
- 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.
- Fluent in English.
- Minimal (10-15%) travel required
- Experience in working cross functionally and with external providers
- Experience with development & implementation of process improvement related initiatives
- Prior experience with Risk Based Monitoring/RBM.
- Experience leading and reporting on audit findings, clinical compliance, inspection readiness and risk assessments.
- Ability to influence and facilitate cross functional team effectiveness and results.
- Experience leading new process changes and understanding of Change Management principals.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Clinical Science