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
[https://nam12.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.astellas.com%2F&data=04%7C01%7Cseth%40recruitrooster.com%7C59d7121876474762797c08d92ce14af5%7Cf4e1fd9942ea4d61957ae47394505924%7C1%7C0%7C637590168405503237%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=iaBVZrKeN7JRw3YZwXpqm%2FiJYBkbTiB0bxaXAq7xeLw%3D&reserved=0].
This position is based in Ontario, Canada. 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
- Responsible for the management of budgets, timelines and resources for
assigned clinical trial responsibilities
Qualifications
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
- Must have relevant clinical pharmacology/phase I clinical trial 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
- Proficient in English
- Moderate (~25%) travel required
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
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
- RRSP 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
