Clinical Trial Manager

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.

Purpose:

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, 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, site communications 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 including overseeing vendor data reconciliations
• 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 with associated vendor contracts, including tracking and data in associated systems
• Participate in or lead set-up of the TMF and 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
• 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
• 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 (~15%) travel required

Preferred:

• Bachelor’s Degree or equivalent
• Demonstrated vendor management experience
• Ph I experience in Rare Disease, Gene Therapy, Pediatrics

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.

Salary Range: $107,100- $168,300 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience, and organizational equity considerations).

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
• Company-paid fleet vehicle for eligible positions
• Referral bonus program

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