Project Manager - BABE/Clinical Trials

Job Title: Project Manager for BA/BE and Clinical Trials

Company: QPS Bioserve

Location: Hyderabad, India

Experience: 8 - 12 years

Employment Type: Full-Time, Permanent

Industry: Clinical Research / Contract Research

Job Overview:

QPS Bioserve is seeking a Project Manager for Bioavailability/Bioequivalence (BA/BE) and Clinical Trials. This role involves the management and coordination of clinical research projects, primarily in late-phase clinical trials for drug candidates. The Project Manager will be responsible for ensuring smooth execution and effective communication throughout the project lifecycle. The ideal candidate should have experience in clinical project management, preferably within the Contract Research Organization (CRO) industry.

Key Responsibilities:

• Project Management: Lead the implementation, coordination, and execution of clinical research projects and studies (including NCEs and Generics) in Phase I clinical trials for drug candidates, based on client needs.
• Team Leadership: Maintain a cohesive, highly effective project team during all phases of the assigned clinical project.
• Primary Point of Contact: Serve as the main contact for the project team, ensuring clear communication and the smooth flow of information throughout the project lifecycle.
• Global Coordination: Assist in the execution of clinical research services, coordinating with global resources and counterparts in other QPS locations as required.
• Client Interaction: Regularly communicate with clients, providing project updates and coordinating conference calls, as well as preparing and sharing meeting minutes.
• Proposal Preparation: Assist in the preparation of proposals for Clinical Research Services (CRS).
• Business Development: Support efforts to obtain new clients and increase business, presenting the companys capabilities to potential clients.
• SOP Development: Contribute to the creation and revision of Standard Operating Procedures (SOPs) for CRS services.
• Reporting & Target Management: Prepare and deliver monthly reports and updates, ensuring that targets and goals are met.
• Client Visits & Audits: Participate in client visits, pre-qualification audits, and regulatory audits as needed.

Preferred Candidate Profile:

• Educational Qualifications:
• PG: M.Pharma in any specialization, MS/M.Sc (Science) in any specialization, MBA/PGDM in any specialization
• Experience: 8 - 12 years in clinical project management, with experience in BA/BE studies and clinical trials. Experience in the CRO industry is highly desirable.
• Key Skills:
• Project Monitoring
• Project Coordination
• Client Coordination
• Project Planning and Execution
• Project Scheduling
• Communication Skills
• PMP (Project Management Professional) Certification is a plus
• Strong Management Skills
• Study Updates and Project Tracking

About QPS Bioserve:

QPS Bioserve is a leading Contract Research Organization (CRO) founded in 1995, offering a wide range of services to support discovery, preclinical, and clinical drug development. QPS is known for providing GLP/GCP-compliant services to pharmaceutical and biotechnology clients worldwide.