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 .We are a global pharmaceutical company dedicated to transforming innovative science into medical solutions that deliver value and hope to patients and their families. By focusing on addressing unmet medical needs and operating with ethics and integrity, we strive to enhance the health and well-being of people worldwide.Astellas’ Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico. The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
Purpose And Scope
- Responsible for execution of work within the Global Site Payment support function in support of both early and late-stage Clinical Operations.
- This position supports site payment related activities and will report on performance timelines.
- This position is accountable for the timely delivery of clinical site payments according to the site contract timelines.
Essential Job Responsibilities
- Responsible for the effective management of site payments to investigative sites within the Veeva Site Payment system
- Manage and support the day to day operations of site payment processing per established contractual agreements and objectives in compliance with applicable GCP / ICH guidelines and other JSOX / FAR requirements
- Provide regular updates of payment status to Clinical Study teams and leadership
- Data entry support into Veeva Site Payment system or CTMS system
- Site Payment related activities, as required, including the supplier onboarding activities, mailbox management, invoice review and upload, invoice approval against CTMS and EDC (other source data as required), and invoice confirmation for payment
- Support investigator payments from invoice receipt through payment including monitoring of status throughout the process to ensure compliance with contract timelines
- Manage pro-forma invoice payments as needed
- Support of advance payment and suitability / pre-payments
- Collaborate with cross functional stakeholders as process requires, including feasibility, study start up, contracts, budget and study team members
- Work to proactively identify and resolve payment issues that arise throughout the life of the study (study start up, conduct and close out) including support and oversight of site payment escalations
- Oversee site payment systems, standards and processes to ensure timely payment of the investigative sites (either via our vendors or internal payment via Veeva)
- Support of input into site payment metrics for functional area, including but not limited to the input, measurement and monitoring.
- Bachelor’s Degree or equivalent relevant experience
- At least 1 to 3 years prior experience handling and executing on functional specific material (e.g. site payments or related payment or budget related material) matters
- Understanding of the regulatory, legal and data privacy issues affecting the pharmaceutical industry, including GDPR as it relates to the core and country templates.
- Strong ability to grasp regulatory and legal issues quickly, exhibit strong analytical problem solving and decision-making skills, exercise sound judgment.
- Strong communication skills (both oral and written).
- Must have a knowledge of clinical development processes and ICH/GCP
- Must have strong interpersonal, written, verbal, and computer skills.
- Minimal (10%) travel required
- Fluent in English
Preferred Qualifications
- Experience working in a Global environment
Working Environment
- At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Category Site Activation / Late-Stage Management
Astellas is committed to equality of opportunity in all aspects of employment.EOE including Disability/Protected Veterans
