Astellas Pharma Clinical Specialist CS CoE Support in Northbrook, Illinois
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 assist in 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).
Essential Job Responsibilities:
Provide administrative support related to various clinical systems/technology utilized by Clinical Science.
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
Generate and 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
Effectively execute against assigned activities within relevant support function.
This may include:
Assist study teams in the implementation of patient centered approaches for clinical trials inclusive of Clinical Science approaches to Decentralized trials and/or
Assist in executing against assigned Clinical Science Compliance related activities (e.g. completion of effectiveness checks) and/or
Provide administrative support related to the processing and finalization of clinical study contracts and other related documentation and/or
Assist CS Vendor oversight/performance team through support of governance meeting preparation, generation of meeting minutes/follow-up actions, generation of key performance measures, completion of vendor related documentation and/or
Provide administrative support for various clinical systems/technology utilized by Clinical Science including central processing support (e.g. study invoices) to study teams and/or
Support meeting preparation materials and documentation of follow-up items in support global study operating model and/or sustainability and optimization of the CRO/Sponsor Partnership for Clinical Science and/or
Assist with maintenance training related assignments/curriculum
Responsible for complying with regulations and guidelines and ensuring adherence in support of clinical trial relates support function activities
Reports to the Sr. Manager, Clinical Science or above. This position has no direct reports.
Associates degree with at least 2 years of experience in the health care field or at least 5 years of direct clinical trial related experience.
General knowledge of drug development and 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
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
Category Medical & Development
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans