Astellas Pharma Associate Manager Clinical Science Center of Excellence (Process and Training) 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 an Associate Manager Clinical Science Center of Excellence (Process and Training) opportunity in Northbrook, IL.
Position & Scope:
This position will support the execution of assigned responsibilities within the relevant Clinical Science support function with operational excellence
Support functions in scope for this position may include: Clinical Standards and Compliance (overall study operational and support model, Clinical Compliance and Clinical Legal Operations) and Vendor Operations and Performance Management (Vendor Governance and Portfolio Performance Management; Technology, Data Enablement and Standards; Clinical Trial Patient Centered Support, Clinical Safety Notifications, Departmental Resourcing, Staff Onboarding/Offboarding and Administrative Support).
May provide input into budgets and timelines related to assigned deliverables.
Essential Job Responsibilities:
- Support the day-to-day operations of assigned activities 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
Support management of 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 assigned activities associated with relevant support function. This may include:
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
- Provide support for Clinical Science Compliance related activities inclusive of completion of process related effectiveness checks, and CS inspection readiness activities (including preparation and responses) for audits, inspections and regulatory findings and/or
- Support Clinical Science Vendor oversight/performance activities inclusive of support for vendor governance meetings, review of key performance measures, vendor related documentation etc. and/or
- 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
- Support the sustainability and optimization of the CRO/Sponsor Partnership processes for Clinical Science and/or
- Provide operational support related to technology and data enablement for the CS organization and/or
- Support maintenance of CS QD changes and training related assignments/curriculum
Responsible for input on the functional budgets and resources (where appropriate) and management of related components of assigned activity budgets, timelines and resources.
Reports to the Sr. Manager, Clinical Science or above. This position has no direct reports.
- BA/BS degree with at least 3 years of experience (or 2 years direct experience with an advanced degree (MS/PhD/PharmD)) in pharmaceutical drug development
- Must have knowledge of clinical trial conduct
- Must have knowledge of ICH/GCP guidelines
- Requires proven project management skills
- Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
- Fluent in English.
- Minimal (0-5%) travel required
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Clinical Science