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 Bangalore, India. We recognize the importance of work/life balance. We believe in optimizing the most productive work environment for all employees to succeed and deliver.

Purpose and Scope:

This position will assist the Clinical Trial Lead (s) and Clinical Trial Manager(s) in the day-to-day operations, set-up, execution and close-out 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 team for the support of the 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 Clinical Operations Functional Manager, or Clinical Operations Lead.

Responsibilities and Accountabilities:

Support the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team objectives, milestones and deliverables, in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
Responsible for ensuring maintenance of accurate and up-to-date trial information within relevant tracking systems and providing regular updates as requested to trial team and other defined stakeholders.
Participate in the development of trial plans and system set-up including implementation of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors, and data.
Participate in site feasibility assessment and maintenance of associated data for trial conduct.
Participate in CRO and vendor set-up and management during clinical trial execution, as requested by clinical trial lead and/or clinical team.
Participate in or lead TMF set-up and maintenance to ensure quality and completeness.
Participate in trial team meetings and manage associated documentation as requested.
Participate in coordination of data cleaning and data reviews as requested.
Participate in set-up and coordination of investigator and site monitor training, as appropriate.
Participate in the coordination of patient-focused strategies for assigned trials, as appropriate.
Responsible for complying with regulations, GCP, SOPs and established standards during trial set-up, conduct and close-out.

Required Qualifications:

Must have BA/BS degree or Associates degree with at least 2 years of experience in the health care field
Must have excellent interpersonal, written, verbal, presentation administrative and computer skills. Fluent in English (oral and written)
General knowledge of drug development and ICH/GCP guidelines
Fluent in English
Minimal (0-5%) travel required

Preferred Qualifications:

Advanced Degree

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