Assistant manager

Job Description

Department: Clinical Operations

About Syngene

Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

Job Description

Key Responsibilities:

• Manage and co-ordinate efforts of Clinical Trial Management department and cross-functional project teams to support project milestone achievement and to manage study issues and obstacles
• Develop Project Management Plan
• Coordinate with cross-functional departments/Sponsor/Vendor for development of study management plans
• Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to
• Ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures during the project tenure
• Collect information on team performance against contract, customer expectations and project baselines
• Lead problem solving and undertake resolution efforts for management of risks, contingencies and issues
• Identify quality issues within the study through regular review of the clinical team communications including site communications, monitoring visit reports, data flow information and quality assurance audit findings, to implement appropriate corrective action plans, escalate findings and action plans to appropriate parties
• Providing ongoing training and support to the clinical team
• Ensure high performance and efficiency of the clinical team through co-monitoring/accompanied site visits
• Mentor and provide oversight to the Clinical Research Associate team and scheduling accompanied visits with Clinical Research Associate for pre-study, initiation, monitoring and close-out visits as part of their on-site assessment
• Prepare and present project information at internal and external meetings
• Conduct monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic areas
• Ensure data quality, compliance with protocol, relevant SOPs and regulations at study sites for which Senior Clinical Research Associates/ Clinical Research Associates is responsible (if applicable)
• Provide/ facilitate training, development, performance and retention of assigned clinical team
• Meet with Senior Clinical Research Associates, Clinical Research Associates, Senior Project Associates and Project Associates on a regular basis to monitor workload and performance
• To review and validate timesheet of Senior Clinical Research Associates/ Clinical Research Associates and provide input to reporting managers of their project team members performance and deficiencies in timesheet entries relative to project tasks
• Provide input for the development of proposals for new work and manage project budgets.
• Participate in performing site feasibility for awarded studies
• Develop and review of departmental Standard Operating Procedures and working practices
• Co-ordination with Quality Assurance (QA) team for the closure of audit findings both in-house and on-site audits
• As reporting manager (if assigned), manage the team in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning and directing work; goal setting, appraising performance and guiding professional development; training, rewarding and disciplining employees; addressing employee relations issues and resolving problems

Educational Qualification

M.Sc/Pharm-D/MBBS/BAMS/BHMS or PhD in Pharmacy or Lifesciences

Experience

6 - 9 Years

• Should have good communication skill and should be a good team player.
• Ability to work successfully in a dynamic, ambiguous environment.
• Ability to meet tight deadlines and prioritize workloads.
• Ability to develop new ideas and creative solutions.
• Should be a focused employee.

Equal Opportunity Employer

In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.