Clinical Trial Specialist
Clinical Trial Specialist
Astellas
Job description
Interested in a career in clinical trial operations and drug development? Explore the Clinical Trial Specialist position at Astellas, Bengaluru.
Company Description
Astellas is a multinational pharmaceutical firm that uses creative research to improve the health of people across the world. The company operates in over 70 countries and is developing transformational therapeutics across fields like oncology, ophthalmology, urology, immunology and women’s health.
Position Overview
This role will be in Bengaluru and will support the operational delivery of assigned drug trials during the lifecycle of the trial. This role assists with the set-up, execution and close out of trials in conjunction with Clinical Trial Leads, Clinical Trial Managers, global cross-functional teams, investigative sites, CROs and vendors. Depending on the study, the position may involve conducting interventional drug trials, Clinical Pharmacology studies with healthy volunteers, pre-approval access activities and post-marketing regulatory commitment trials.
Key Responsibilities
Assist with the operational aspects of assigned clinical trials and project goals, objectives and deliverables are reached.
Make sure that trial information is up to date and correct in the appropriate tracking systems and provide changes to the trial teams and stakeholders.
Support the formulation of trial plans and the establishment of systems, processes and standards required to conduct trials effectively.
Participate in site feasibility studies and keep information relevant to the conduct of the experiment.
Help in the setup & management of CRO and vendor during the clinical trial execution.
Participate and/or lead the Trial Master File (TMF) set-up and maintenance with an emphasis on quality and completeness of the documentation.
Attend trial team meetings and manage related documents.
Support data cleansing and data review coordination operations.
Ensure that trial activities are performed in compliance with applicable regulatory requirements, ICH-GCP guidelines, SOPs and established standards.
Educational Qualification
Advanced degree (MS, PhD or PharmD) and at least 2 years clinical trial experience.
Required Skill Set
Good knowledge of ICH-GCP guidelines and associated regulatory requirements.
Knowledge of clinical protocols and clinical drug development process.
Knowledge of clinical trial design, planning, management and monitoring.
Project management and trial leadership skills.
Excellent interpersonal and team skills.
Good written, verbal and presentation communication skills.
Excellent administrative and computer skills.
Proficiency in spoken and written English.
Strong ability to collaborate successfully with global cross functional teams, CRO’s, vendors and other trial stakeholders.
Salary
The average salary range for the role of Clinical Trial Specialist is ₹10 Lakhs to ₹12 Lakhs per year.
Professional Development
This position can provide experience in clinical trial operations, TMF management, vendor coordination, trial planning, GCP compliance, and communication with global stakeholders, which can be a great basis for moving into wider clinical operations and trial management roles.
Application Process
Visit our job portal for the role of Clinical Trial Specialist
Click on the listing to get the job details.
Fill up your information and upload your resume.
Submit your application.
Education
Postgraduate Degree (Master's/PhD)
Key Skills
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Salary Insights
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Hiring Trends
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