Associate Analyst (PRI)

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

• Your ideas influence the way we work, and your voice matters here.

• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

• Collects the basic minimum required details about the study from the Sponsor and communicates to internal team 

• Creates CDA and Feasibility questionnaires as required 

• Communicates and co-ordinates the sending and collecting of essential documents from Site /CRO/Sponsor. 

• Ensures quality of documents prior to sending 

• Creates and maintains tracking for all documents and activities 

• Communicates with Line Manager for the conduct of Site Selection visits and ensures preparedness of the site 

• Tracks progress of start-up activities, conducts internal meetings, assesses site status and communicates to CRO/Sponsor accordingly 

• Helps ensure the availability of standard documents required for the IP release and the Site initiation. To coordinate the collection and distribution of site related performance data/ information to/from the sites and sponsors. Co-ordinate the activities related to training, sharing best practices, creation of management information systems and processes to efficiently manage the Cytespace site network. 

• Performs periodic reviews of logs and trackers in accordance with defined processes or as required by CRO/Sponsor. 

• Tracks closure of action items, eCRF data entry timelines and other performance metrics 

• Supports Line Managers analysis of SSE performance by: 

• Review ing SSE and site performance metrics related to patient pre-screening, recruitment, paper CRF or eCRF completion timelines, query resolution or management, maintenance of Investigator Site File and other trial related study documents including trial master file and study documentation upkeep at Site, patient visit follow up and compliance at site, IP and supplies accountability at Site, prepare site for monitoring visits, QA visits and sponsor visits, coordinate monitoring visit/ audit action items closure at site, tracking of investigator/site payments and patient reimbursements per contract 

• Reporting metrics of site performance 

• Reviewing  the site processes, identify gaps and support roll-out of site processes 

• tracking and working with SSM to assist the SSE in closing all project outstanding Action Items while the study is in start up, ongoing or during close out 

• Collates and analyses study and non-study data to provide suggestions for continuous improvement in quality of project deliverables. 

• sets up calendars for Study Specific Metric collation and delivery and drives the process of collection and analysis of key site data essential for the Metric. Facilitates activities between site solutions and client when necessary. 

• Identifies and recommends new sites in a given geography