Associate Manager CS Center of Excellence, Clinical Site Contracts
- Employer
- Astellas Pharma US, Inc.
- Location
- Northbrook, Illinois
- Start date
- Sep 25, 2022
View more
- Discipline
- Clinical, Clinical Research, Sales & Service, Customer Service
- Required Education
- Bachelors Degree
- Position Type
- Contract
- Hotbed
- BioMidwest, Best Places to Work
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 www.astellas.com .
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
Quantitative Dimensions:
Responsible for input on the functional budgets and resources (where appropriate) and management of related components of assigned activity budgets, timelines and resources.
Organizational Context:
Reports to the Sr. Manager, Clinical Science or above. This position has no direct reports.
Qualifications:
Required
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
Benefits:
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
#LI-SS
Category Clinical Science
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
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