Manager Clinical Science Center of Excellence (Clinical Compliance - Risk Based Monitoring) at CareerBuilder

Posted in Other 8 days ago.

Location: Northbrook, Illinois

Job Description:

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 Manager Clinical Science Center of Excellence opportunity.

Position & Scope:

This position is responsible for 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).

Accountable for management of budgets, timelines, and workload.

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 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 all activities associated with 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
* Provide oversight and direction to team members for functional and study-related deliverables

Quantitative Dimensions:

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.

Organizational Context:

Reports to the Sr. Manager, Clinical Science or above. This position has no direct reports but may provide oversight and direction to team members for deliverables and may provide direct supervision for contract team members.



* BA/BS degree with at least 5 years of experience (or 3 years direct experience with an advanced degree (MS/PhD/PharmD)) in pharmaceutical drug development
* 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



Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled