PHARMAFull-time
Clinical Trial Manager
By Admin · Clinical Research & Clinical Operations
BANGALORE (IN)HYBRIDPOSTED: 9/22/2026
PHARMAFull-time
HIRING ORGANIZATIONASTELLASPharmaceuticals and Life Sciences
ROLE OVERVIEW
Clinical Trial Manager responsible for planning, setting up, and executing assigned clinical trials while coordinating cross-functional teams, vendors, investigators, sites, budgets, timelines, and trial deliverables in compliance with GCP, ICH, SOPs, and regulatory requirements.
ROLE DEFINITION & RESPONSIBILITIES
- •Manage day-to-day operations of assigned clinical trials in compliance with GCP, ICH, and regulatory requirements
- •Lead or support cross-functional trial teams and vendors
- •Maintain accurate trial information in tracking systems and communicate trial progress to stakeholders
- •Identify, resolve, and escalate trial conduct issues
- •Develop or support trial documents, plans, systems, and operational processes
- •Support vendor requirements, scope development, vendor selection, and vendor performance management
- •Conduct or support country and site feasibility and investigator/site engagement
- •Oversee clinical aspects of data cleaning, analysis, data reviews, and top-line results
- •Coordinate investigator, site monitor, and therapeutic-area training
- •Manage clinical trial budgets, vendor contracts, timelines, and resources
- •Ensure completeness of the Trial Master File and support inspection readiness
- •Support patient-focused strategies where applicable
Reporting Hierarchy: Reports to the Functional Manager, Clinical Operations or Clinical Operations Lead; Accountable to the Clinical Trial Lead and Operations Lead for trial execution; No direct reports, but provides oversight and direction to trial team members and vendors
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- BA/BS degree with at least 3 years of clinical trial experience or equivalent direct experience
- OR MS, PhD, or PharmD with at least 2 years of clinical trial experience
- Strong knowledge of ICH/GCP guidelines and regulatory requirements
- Knowledge of clinical drug development, protocol development, clinical trial design, planning, management, and monitoring
- Project management and trial leadership skills
- Strong interpersonal, written, verbal, administrative, and computer skills
- Fluent English
- Willingness to travel approximately 25%
PREFERRED QUALIFICATIONS
- •Advanced degree
- •Experience managing and overseeing Clinical Research Associates
- •Experience monitoring and supporting clinical trial activities across India sites
- •Experience conducting site oversight visits
- •Vendor and CRO management experience
- •Strong investigator and site relationship management experience
REQUIRED VERIFIED SKILLS
Clinical trial management
clinical operations
ICH-GCP
regulatory requirements
clinical trial design
protocol management
trial planning
site management
vendor management
CRO management
TMF
inspection readiness
clinical data review
budget management
project management
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Hybrid working solution; work/life balance support; global collaboration; professional development; supportive work environment; opportunities for innovation and career growth
The supplied posting does not disclose a salary range, bonus, or equity package. Compensation should be confirmed directly with Astellas during recruitment.
ORGANIZATION CONTEXT & CULTURE
Astellas is a global life sciences company developing transformative therapies in areas including oncology, ophthalmology, urology, immunology, and women's health. The company focuses on innovative science and solutions for diseases with high unmet medical need.
TEAM SIZE: 10,000+ employees
INDUSTRY: Pharmaceuticals and Life Sciences
Culture: Astellas emphasizes innovation, integrity, impact, global collaboration, accountability, courage, urgency, and an outcome-focused approach. The company highlights a supportive growth culture and flexible hybrid working.
EXPECTED CAREER ROADMAP
Potential progression may include Senior Clinical Trial Manager, Clinical Operations Lead, Clinical Trial Lead, Associate Director Clinical Operations, and broader clinical development leadership roles depending on experience and organizational opportunities.
APPLICATION ADVISORY
Highlight hands-on clinical trial management experience; demonstrate strong ICH-GCP and regulatory knowledge; emphasize India site and investigator management; showcase CRO/vendor oversight and budget management; mention TMF and inspection-readiness experience; demonstrate project leadership and issue escalation skills; include experience with trial planning, site feasibility, monitoring, and clinical data review; note willingness to travel approximately 25%.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.