Job Title: Project Manager – BA/BE Services
Department: Clinical Research / BA/BE Services
Experience Required: 7+ Years
Role Overview
The Project Manager – BA/BE Services is responsible for end-to-end project management of bioavailability/bioequivalence (BA/BE) studies. The role focuses on client coordination, project execution, cross-functional collaboration, and ensuring timely delivery in compliance with regulatory and organizational standards.
Key Responsibilities
1. Project Management & Delivery
Manage end-to-end coordination of BA/BE projects for assigned clients
Ensure timely delivery of projects in line with agreed timelines and milestones
Publish and track project schedules with defined milestones
Contribute to achieving overall project objectives
2. Client & Stakeholder Management
Serve as the primary point of contact for clients
Maintain effective communication and strong client relationships
Facilitate sponsor visits during ongoing and retrospective study monitoring
Communicate project goals and updates across the organization
3. Feasibility & Contract Management
Conduct feasibility assessments for BA/BE studies
Develop proposals and follow up with clients
Finalize project contracts in coordination with stakeholders
4. Compliance & Quality Assurance
Ensure all activities comply with SOPs, processes, and management requirements
Act as management designee in double-blinded studies when assigned
5. Cross-Functional Coordination
Coordinate with internal teams (clinical, bioanalytical, data management, etc.)
Manage collaboration between clinical data entry teams and CDS team for CDISC datasets
Maintain strong interpersonal relationships with study teams
6. Operational Coordination
Facilitate inventory management of:
Biological samples
Investigational products
Study-related documents
Ensure proper tracking and storage coordination
7. Reporting & Documentation
Manage Clinical Study Report (CSR) schedules and dispatch activities
Support project documentation and reporting requirements
8. Meetings & Communication
Conduct and coordinate:
BCSO calls for BA/BE center capacity utilization
IEC coordination calls
IP and plasma sample storage discussions
Required Skills & Competencies
Strong project management and organizational skills
Excellent client communication and stakeholder management abilities
Knowledge of BA/BE study processes and clinical research operations
Ability to manage multiple projects and priorities simultaneously
Strong problem-solving and decision-making skills
Preferred Experience
7+ years of experience in BA/BE project management
Experience working in clinical research or CRO environments
Familiarity with CDISC datasets and clinical data management processes
Personal Attributes
Strong leadership and team collaboration skills
Detail-oriented with a focus on quality and compliance
Ability to work under pressure and meet deadlines
Proactive and solution-driven mindset
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