Job Description

Company Description
PSI is a passionate, organically grown, and award-winning full-service CRO who dares to be different. As a dynamic and global company, we bring together more than 2,700 driven and dedicated experts across 60 countries working collectively to help make a positive impact on patient lives.


We\'re on the lookout for a knowledgeable, proactive and dedicated person to lead and develop our Clinical Operations team in India and Singapore. In this role, you will enjoy all aspects of operational & strategic management. Office-Based in Bangalore Department Management

• Line management of Clinical Operations staff in the country/region
• Performance appraisals, hiring, fostering career advancement of staff

Resource Management & Training

• Resource allocation to projects and resolution of resourcing conflicts
• Oversight of resource workload and utilization
• Mentoring and coaching, oversight of training planning and completion

Quality Control & Quality Assurance

• Development and implementation of quality systems, including QSDs
• Implementation of quality control within the department
• Preparation for and participation in site and systems audits & regulatory inspections
• Oversight of field training planning, conduct and reporting. Performance of field assessment visits
• Participation in Risk Review Meetings and CAPA investigation meetings

Project Supervision and Project-specific Assignments

• Crisis management and conflict resolution
• Participation in project review meetings with local project teams
• Participation in project-specific site identification and selection process

Business Development

• Participation in feasibility assessment of potential and ongoing projects
• Support with Business Development tasks such as client meetings, trade fairs, key medical events and networking with medical communities and opinion leaders

Qualifications

• College or University degree in Life Sciences or PharmD
• Demonstrated operations experience in a CRO (preferable), or a pharma company
• Experience with clinical research sites, R+D processes, legal, regulatory and ethics in India
• Experience in clinical team management
• Knowledge of local HR line management processes
• Basic financial knowledge
• Excellent English
• Proficiency in standard MS Office applications
• Strong time management, organizational, leadership, planning and presentation skills, result-oriented approach

Additional Information
If you\xe2\x80\x99re looking to advance your career at a company growing organically into new regions around the world, we would love to hear from you! You will receive continuous support from your global peers and join a fast-paced, innovative, and results-oriented working environment with lean communication lines. We pride ourselves on being approachable, receptive to new ideas, and open to feedback.