Maintain system and compliance of Jupiter Global Bio-Research*Monitor clinical trials conducted at the Jupiter Global Bio-Research clinical facility and external clinical sites for compliance with Good Clinical Practice (GCP), clinical trial protocol/amendments, SOPs and applicable regulatory requirements.*Ensure that the rights and well-being of subjects are protected.*Perform Site Initiation Visits (SIV), Pre-Study Monitoring, On-Study Monitoring, and monitoring Close-Out visits.*Review clinical trial source documentation for accuracy, completeness and compliance with Good Clinical Practice (GCP), clinical trial protocol/amendments, SOPs and applicable regulatory requirements.*Verify transcription of source documentation to Case Report Forms (CRFs).*Document each monitoring visit in a monitoring report; follow-up and review site corrective actions to ensure effective resolution.*Submit monitoring reports to the site and Sponsor.*Ensure effective communication with the site and the Sponsor; ensure critical observations are immediately communicated to the site and Sponsor and effective resolution is obtained.*Coordinate and host external Sponsor CRA on-site visits; ensure effective communication between the CRA and Jupiter Global.*Supervise new CRAs as needed.*Ability to travel*Other duties as required.

*Monitor clinical trials conducted at the C-Trials Global clinical facility and external clinical sites for compliance with Good Clinical Practice (GCP), clinical trial protocol/amendments, SOPs and applicable regulatory requirements.*Ensure that the rights and well-being of subjects are protected.*Perform Site Initiation Visits (SIV), Pre-Study Monitoring, On-Study Monitoring, and monitoring Close-Out visits.*Review clinical trial source documentation for accuracy, completeness and compliance with Good Clinical Practice (GCP), clinical trial protocol/amendments, SOPs and applicable regulatory requirements.*Verify transcription of source documentation to Case Report Forms (CRFs).*Document each monitoring visit in a monitoring report; follow-up and review site corrective actions to ensure effective resolution.*Submit monitoring reports to the site and Sponsor.*Ensure effective communication with the site and the Sponsor; ensure critical observations are immediately communicated to the site and Sponsor and effective resolution is obtained.*Coordinate and host external Sponsor CRA on-site visits; ensure effective communication between the CRA and C-Trials Global.*Supervise new CRAs as needed.*Ability to travel*Other duties as required.

*Responsible for creating, coordinating and maintaining the master study scheduled for all sites.*Working with all HODs on regular basis to ensure the relevant project milestones are discussed and needs of sponsor and functional areas are not compromised.*Create, plan and monitor all project activities in PM database ensuring accuracy at all times.*Responsible for identifying interdependencies for all projects and facilitate communication among functional areas where required.*Understand time sensitive nature of critical path project activities and notifies the relevant teams, and or manages the related issues.*Works with management to establish project interim milestones and ensure projects are on schedule to ensure our report structure/compilation is communicated and assisted when required, i.e. CS-BE, FDA tables.*Responsible for providing first level of support for all software problems reported regarding PM database and documenting problems and solutions as required.*Solicit feedback from end users to ensure the database continues to meet the needs of the organization.*Identify opportunities and recommend solutions that will enhance and improve current business process.*Provide basic training to end user on PM database, including cross-functional training.*Maintain and keep count on monthly basis all analytical methods and bioequivalence studies completed.*Attend teleconferences as scheduled for projects and ensure effective communication of project milestone and activities.*Demonstrates the ability to make complex interpretation and application decision within role capacity by utilizing protocol, SOPs or other tools deemed appropriate.*Provide summary reports to management as may be requested.*Participate in ongoing educational activities to enhance the level of knowledge as well as that of other team members.*Performs other duties as requested or assigned by department management and/or Executives, as training experience allow.

*Responsible for creating, coordinating and maintaining the master study scheduled for all sites.*Working with all HODs on regular basis to ensure the relevant project milestones are discussed and needs of sponsor and functional areas are not compromised.*Create, plan and monitor all project activities in PM database ensuring accuracy at all times.*Responsible for identifying interdependencies for all projects and facilitate communication among functional areas where required.*Understand time sensitive nature of critical path project activities and notifies the relevant teams, and or manages the related issues.*Works with management to establish project interim milestones and ensure projects are on schedule to ensure our report structure/compilation is communicated and assisted when required, i.e. CS-BE, FDA tables.*Responsible for providing first level of support for all software problems reported regarding PM database and documenting problems and solutions as required.*Solicit feedback from end users to ensure the database continues to meet the needs of the organization.*Identify opportunities and recommend solutions that will enhance and improve current business process.*Provide basic training to end user on PM database, including cross-functional training.*Maintain and keep count on monthly basis all analytical methods and bioequivalence studies completed.*Attend teleconferences as scheduled for projects and ensure effective communication of project milestone and activities.*Demonstrates the ability to make complex interpretation and application decision within role capacity by utilizing protocol, SOPs or other tools deemed appropriate.*Provide summary reports to management as may be requested.*Participate in ongoing educational activities to enhance the level of knowledge as well as that of other team members.*Performs other duties as requested or assigned by department management and/or Executives, as training experience allow.

*Study start-up activities, Study feasibility and all other activities till documenting and clearing the baseline (Form 1572).*Vendor management, Site management and monitoring site activities.*Project timelines, deliverables, Crashing the project to prevent scope creep.*Regular Communications and meetings with internal Stake holders, Sponsors and Vendors.*Adhering to the regulatory compliance and guidelines. Proper documentation of incidents and deviations occurred by team.*Preparing costing proposals and rate cards.*Filing of BENOC and TL (import permit) on SUGAM DCGI portal (Local regulatory portal).*Query responses to local regulatory on submitted protocol and product documents in order to receive BENOC approval for each study.*Proactively identifying the risk in ongoing studies and ensuring that the problem is fixed in consultation with respective departments and sponsor.*IEC/IRB submission and ensure timely approvals.*Ensuring Project deliverables are met as per agreed terms and conditions or committed timelines.*Escalation of issues to higher ups in order to ensure timely resolution of conflicts.*Proactively identifying the risk in ongoing studies and ensuring that the problem is fixed in consultation with respective departments and sponsor.*Preparing and sharing project charts and tracking of major milestones.*Conduct meetings with internal stakeholders to see that the projects are running seamlessly.*Troubleshooting the optimized threats or factors responsible for delay or change in project.*Reviewing of various agreements and contracts, tracking validity of contracts and agreement, renewal of contracts and agreements.*Importing Investigational medicinal products (IMP)*End to end client study management. *Responsible for providing support to clients regarding CRO services.