Astellas Pharma
Clinical Trial Manager, Early Development, Oncology
Astellas Pharma, Northbrook, Illinois, us, 60065
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 is responsible to support or lead specific activities for the planning, set-up and execution of assigned drug trials which may include: pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).
This position is accountable to the Clinical Trial Lead and Operations Lead for trial execution and works collaboratively with cross-functional team members and vendors to ensure proper set-up of trial processes and plans to execute the protocol with operational excellence and in accordance with SOPs and standards to ensure quality of trial deliverables.
Essential Job Responsibilities:
Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
Leads or supports cross-functional trial teams, including vendors
Ensures accurate and up-to-date trial information within relevant tracking systems and provide regular updates of trial progression to Clinical Operations Lead, Clinical Trial Lead, and other defined stakeholders
Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues
Participate in or lead the development of core trial documents, trial plans and system set-up; participate in preparation and ensure operational excellence of protocol and implementation of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors, and data
Participate in or lead preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial team
Participate in or lead feasibility assessment and selection of countries and sites for trial conduct
Participate in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables
Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans
Participate in or lead set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members
Provide oversight and direction to trial team members for trial deliverables
Manage clinical trial budget and associated vendor contracts, including tracking and data in associated systems
Ensure quality and completeness of TMF for assigned clinical trials
Participates in inspection readiness activities including coordination of clinical trial team deliverables
Participate in the evaluation and implementation of patient-focused strategies for assigned trials, as applicable
Quantitative Dimensions:
Responsible for the management of budgets, timelines and resources for assigned clinical trial responsibilities.
Organizational Context:
Reports to the Functional Manager, Clinical Operations or Clinical Operations Lead. This position has no direct reports but may provide oversight and direction to trial team members for trial deliverables.
Qualifications:
Required
BA/BS degree with at least 3 years clinical trial experience or direct equivalent experience or advanced degree (MS/PhD/PharmD) with at least 2 years clinical trial experience
Early Development Oncology experience
Must have strong knowledge of ICH/GCP guidelines and regulatory requirements
Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring
Requires project management skills and trial leadership ability
Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability
Fluent in English
Moderate (~25%) travel required
Preferred
Advanced Degree
Benefits:
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
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 Oncology Clinical Operations
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
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 is responsible to support or lead specific activities for the planning, set-up and execution of assigned drug trials which may include: pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).
This position is accountable to the Clinical Trial Lead and Operations Lead for trial execution and works collaboratively with cross-functional team members and vendors to ensure proper set-up of trial processes and plans to execute the protocol with operational excellence and in accordance with SOPs and standards to ensure quality of trial deliverables.
Essential Job Responsibilities:
Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
Leads or supports cross-functional trial teams, including vendors
Ensures accurate and up-to-date trial information within relevant tracking systems and provide regular updates of trial progression to Clinical Operations Lead, Clinical Trial Lead, and other defined stakeholders
Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues
Participate in or lead the development of core trial documents, trial plans and system set-up; participate in preparation and ensure operational excellence of protocol and implementation of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors, and data
Participate in or lead preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial team
Participate in or lead feasibility assessment and selection of countries and sites for trial conduct
Participate in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables
Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans
Participate in or lead set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members
Provide oversight and direction to trial team members for trial deliverables
Manage clinical trial budget and associated vendor contracts, including tracking and data in associated systems
Ensure quality and completeness of TMF for assigned clinical trials
Participates in inspection readiness activities including coordination of clinical trial team deliverables
Participate in the evaluation and implementation of patient-focused strategies for assigned trials, as applicable
Quantitative Dimensions:
Responsible for the management of budgets, timelines and resources for assigned clinical trial responsibilities.
Organizational Context:
Reports to the Functional Manager, Clinical Operations or Clinical Operations Lead. This position has no direct reports but may provide oversight and direction to trial team members for trial deliverables.
Qualifications:
Required
BA/BS degree with at least 3 years clinical trial experience or direct equivalent experience or advanced degree (MS/PhD/PharmD) with at least 2 years clinical trial experience
Early Development Oncology experience
Must have strong knowledge of ICH/GCP guidelines and regulatory requirements
Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring
Requires project management skills and trial leadership ability
Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability
Fluent in English
Moderate (~25%) travel required
Preferred
Advanced Degree
Benefits:
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
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 Oncology Clinical Operations
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans