Clinical Study Manager

JOB DESCRIPTION

Job Title: Clinical Study Manager

About Syngene :  Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific  services from early discovery to commercial supply.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene’ s quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

Role Accountabilities

1. 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
2. Develop Project Management Plan                                                                                                        
3. Coordinate with cross-functional departments/Sponsor/Vendor for development of study management plans
4. Serve as primary project contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to
5. Ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures during the project tenure
6. Collect information on team performance against contract, customer expectations and project baselines
7. Lead problem solving and undertake resolution efforts for management of risks, contingencies and issues
8. 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.
9. Providing ongoing training and support to the clinical team.
10. Ensure high performance and efficiency of the clinical team through co-monitoring/accompanied site visits          
11. 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.
12. Prepare and present project information at internal and external meetings.
13. Conduct monitoring visits at assigned sites for protocols that are complex and/or require knowledge in advanced therapeutic areas. 
14. 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)
15. Provide/ facilitate training, development, performance and retention of assigned clinical team.                        
16. Meet with Senior Clinical Research Associates, Clinical Research Associates, Senior Project Associates and Project Associates on a regular basis to monitor workload and performance
17. 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
18. Provide input for the development of proposals for new work and manage project budgets.
19. Participate in performing site feasibility for awarded studies
20. Develop and review of departmental Standard Operating Procedures and working practices                                
21. Co-ordination with Quality Assurance (QA) team for the closure of audit findings both in-house and on-site audits
22. 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

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Accountabilities as a Syngene Leader (only for Leadership Hires)

• Champion effective Environment, Occupational Health, Safety and Sustainability (EHSS) practices for the company and oversee compliance with those practices within Biologics business. Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities.
• Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHSS) mindset as well as the highest standards of quality, integrity, and compliance.

• Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority.

Experience: 15 to 20 years

Equal Opportunity Employer

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.