Clinical Trial Manager

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

 We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

• 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.
• 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.

• →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.

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.
• →Managing and overseeing Clinical Research Associates (CRAs)
• →Monitoring and supporting clinical trial activities across India sites
• →Conducting site oversight visits and maintaining strong investigator/site relationships
• →Vendor and CRO management
• →Fluent in English.
• →Moderate (~25%) travel required.

• Advanced Degree

This position is based in our Global Capability Center in India. 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.

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide. 
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare. 
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions. 

Values: Innovation, Integrity and Impact sit at the heart of what we do. 

Behaviors: We come together as ‘One Astellas’, working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution