Clinical Trial Manager

Astellas
Full Time
₹12 Lakhs - ₹15 Lakhs
Bengaluru
Posted 13h ago

Clinical Trial Manager

Astellas

Job description

Want to pursue a career in clinical research and trial operations? Astellas is recruiting for the role of Clinical Trial Manager in Bengaluru.

 
Company Description 

Astellas is a global life sciences company focused on developing innovative medicines for areas such as oncology, ophthalmology, urology, immunology and women’s health. Its research and development efforts aim to address diseases with significant unmet medical needs and create meaningful value for patients.

 Job Summary 

Based at Astellas’ Global Capability Center in Bengaluru, this role supports the planning, start-up and execution of assigned clinical trials. The Clinical Trial Manager works under the Clinical Trial Lead and Operations Lead while coordinating with cross-functional teams and vendors. Responsibilities include trial oversight, vendor management, site activities, data cleaning and review, budgets, timelines, training, TMF quality and inspection readiness.

Primary Responsibilities

• Supervise the day-to-day operations of assigned clinical trials to ensure that project objectives are met in compliance with GCP/ICH guidelines and all applicable regulatory requirements.

• Lead or support cross functional trial teams including external vendors and offer direction for trial deliverables.

• Maintain accuracy and timeliness of clinical trial information in applicable tracking systems and provide progress reports to Clinical Operations Leads, Clinical Trial Leads and stakeholders.

• Early identification of operational issues and working toward resolution, and escalation of trial related issues as needed.

• Support or lead the preparation of key trial paperwork, trial planning and system set-up, contributing to standardized processes and quality across sites, vendors and trial data.

• Support feasibility work and the selection of countries and investigative sites for clinical trial participation.

• Maintain communication with investigators and site staff to help achieve trial milestones and planned deliverables.

• Oversee clinical aspects of data cleaning, data analysis and availability of top-line results, including participation in data reviews and statistical analysis plan reviews.

• Help establish investigator and site-monitor training and coordinate operational and therapeutic-area training for internal and external trial team members.

• Manage clinical trial budgets and related vendor contracts, including maintaining associated tracking information.

• Ensure that the Trial Master File (TMF) is complete and maintained to the required quality standards.

• Support the assessment and implementation of patient-focused strategies when appropriate for assigned trials.

• Manage the budgets, timelines and resources associated with assigned clinical trial responsibilities.

 Educational Qualification 

• Candidates with an advanced degree such as MS, PhD or PharmD (should have at least 2 years of clinical trial experience).

 Skills Required 

• Good knowledge of ICH/GCP guidelines and regulatory requirements.

• Knowledge of clinical drug development and clinical trial protocols.

• Clinical trial design, planning, management and monitoring knowledge.

• Outstanding project management skills.

•Prior experience in managing/supervising Clinical Research Associates (CRAs).

• Oversee and assist clinical trial operations at India-based sites.

• Experience executing site monitoring visits and establishing productive, collaborative relationships with investigators and site teams.

• Skills in Vendor & CRO Management

• Good interpersonal, written and oral communication abilities.

 Salary 

Clinical Trial Manager Salary in India ranges between ₹12 Lakhs to ₹15 Lakhs per year.

 Career Development 

This role is a great chance to improve abilities in clinical trial operations, project management, vendor management, site management and regulatory compliance and get experience working with cross-functional teams in the global pharmaceutical sector.

 Application Procedure 

• Go to our job portal and find the Clinical Trial Manager position.

• Click on the job title to see the full job information.

• Fill your data and upload your resume.

• Submit the application.

 

Employment Type: Full Time
Industry: Healthcare
Role Category: Pharmacy
Application: External (Company Site)

Education

Postgraduate Degree (Master's/PhD)

Key Skills

PharmacyNon Clinical JobsClinical Research

Market insights & trends

Salary Insights

The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.

Hiring Trends

The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.

Frequently Asked Questions

Everything you need to know about the process

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