Project Manager – BA/BE Services | Clinical Research & Bioequivalence
Company: Not Disclosed
Location: India
Job Type: Full-Time
Work Mode: On-site / Hybrid (as per company policy)
Experience: 7+ Years
Category: Clinical Research / Project Management / Bioequivalence (BA/BE)
Job Overview
We are hiring an experienced Project Manager – BA/BE Services to lead bioavailability (BA) and bioequivalence (BE) clinical studies from initiation to completion.
This role is critical in ensuring end-to-end clinical project management, including client communication, regulatory compliance, study timelines, and cross-functional coordination.
You will play a key role in delivering high-quality BA/BE studies aligned with ICH-GCP, regulatory guidelines, and CDISC standards, supporting global drug development and generic product approvals.
Key Responsibilities
Project Management & Client Coordination
Lead end-to-end BA/BE project execution for assigned clients
Act as the primary client interface, ensuring effective communication and satisfaction
Manage project timelines, milestones, and deliverables
Feasibility & Proposal Development
Conduct study feasibility assessments for BA/BE projects
Develop and finalize proposals and project contracts
Support business development and client onboarding
Clinical Study Coordination
Coordinate double-blinded studies as management designee when required
Facilitate sponsor visits, monitoring activities, and audits
Ensure compliance with study protocols, SOPs, and regulatory standards
Cross-Functional Collaboration
Coordinate with clinical operations, data management, bioanalytical, and regulatory teams
Manage clinical data entry and CDISC dataset coordination
Ensure smooth execution across departments
Documentation & Reporting
Manage Clinical Study Report (CSR) timelines and dispatch activities
Maintain proper tracking of investigational products, biological samples, and study documents
Oversee documentation for IEC submissions and study compliance
Operational Excellence
Publish and track project schedules and milestones
Conduct capacity utilization discussions (BCSO calls)
Coordinate IP/plasma sample storage and regulatory calls
Ensure adherence to ICH-GCP, CDISC, and regulatory guidelines
Required Skills & Qualifications
Education
Bachelor’s / Master’s degree in Life Sciences, Pharmacy, Clinical Research, or related field
Experience
Minimum 7+ years of experience in BA/BE project management
Strong background in clinical research and bioequivalence studies
Technical Skills
Expertise in BA/BE study design and execution
Strong knowledge of ICH-GCP, regulatory requirements, and SOP compliance
Familiarity with CDISC datasets and clinical data management
Experience in CSR management and regulatory documentation
Core Competencies
Strong project management and leadership skills
Excellent client communication and stakeholder management
Ability to manage multiple projects and tight deadlines
Problem-solving mindset with attention to detail
Strong organizational and coordination skills
Preferred Skills
Experience in generic drug development and regulatory submissions
Exposure to bioanalytical studies and clinical pharmacology
Familiarity with IEC processes and regulatory approvals
Experience handling global clients and CRO operations
Perks & Benefits
Opportunity to lead high-impact BA/BE clinical studies
Exposure to global regulatory submissions and drug approvals
Career growth in clinical project management and CRO leadership roles
Collaborative work environment with cross-functional teams
Involvement in end-to-end drug development lifecycle
Compensation
Salary Range: Not disclosed (competitive as per industry standards and experience)
About the Company
A growing clinical research organization (CRO) specializing in bioavailability and bioequivalence studies, supporting pharmaceutical companies in generic drug development, regulatory submissions, and clinical trial execution aligned with global standards.
Call to Action
If you want to lead end-to-end clinical projects and play a key role in drug approvals, this is your opportunity.
Step into a leadership role where your decisions directly impact clinical trial success, regulatory compliance, and patient access to medicines.
👉 Apply now and become a driving force in BA/BE clinical research! 🚀
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