Associate Manager CS Center of Excellence, Clinical Site Contracts
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at [Register to View] .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and 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:
The Associate Manager COE will support Clinical Site/ Investigator Contracts (CSIC) team within the Clinical Science COE. In this role, the candidate will be the primary liaison with the designated vendor supporting Clinical Site/ Investigator contract negotiation. This role is responsible for supporting the study team with project management, vendor oversight, review and escalation of contracts and legal documents. This role will support vendor activities as it relates to the development and maintenance of master level and site-specific clinical trial agreements, work orders, and a range of other contract and legal document types. Responsibilities will include ensuring that these agreements are in compliance with Astellas' legal and compliance policies. Among other things that may be assigned from time to time, this individual will be responsible for the following:
- Interfacing with clinical study team members, department leadership, and supporting business functions as required to resolve issues
- Contributing to a system documenting established contracting precedents in order to support future efficiencies
- Leading and/or participating in cross-functional teams relating to Astellas projects
- Supporting the development and ongoing maintenance/updates of contract templates and playbooks for multiple contract types
- Adhering to established timelines regarding review and escalation of contract revisions, and managing other internal reviewers toward meeting these timelines as well
- Supporting general activities associated with the Clinical Site/ Investigator Contracts, Budget and Payments teams
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.