JSS Medical Research - Project Manager - Clinical Research

Job description :

Only Clinical Research experience candidates need to apply.

Essential Functions:

The following duties represent the principle job duties however they are not all inclusive:

- Select clinical investigators / sites depending upon the therapeutic area study phase

- Negotiate the study budget and any other contract agreements required by the Sponsor / JSS

- Meet Clinical Investigators and their team prior to study initiation

- To strategize for timely enrollment

- Monitor study progress to assure compliance with protocol requirements, applicable regulations, guideline & Good Clinical Practices

- Perform site monitoring visits

- Monitor APM & CRA performance

- Identify mitigate study specific issues

- Coordinating with vendors

- Ensuring the study is completed within budgeted timelines and resources

- Tracking the enrollment and retention of subjects at each site

- At SCOV ensure collection/reconciliation of all data and remaining study supplies for return to the sponsor

- Prepare the site for possible inspection

- Coordinating with vendors as applicable for the study

- Coordinating with the PIs for site contracts

- Ensuring Clinical Trial Material compliance if applicable

- One point of contact for the sponsor

- Providing timely updates to the sponsor

- Ensuring the study is completed within budgeted timelines and resources

Skills and Qualifications:

Knowledge of: > 5 Years CR experience

- MBBS/ BDS/ Postgraduate- Lifesciences

- MS Office

- Requirements of Good Clinical Practices

- Requirements of Good Documentation Practices

- Requirements of FDA 21 CFR Part 11 for Handling of Electronic Records

Key Skills - Clinical research, Clinical trials, onsite monitoring, project management