Clinical Trial Associate
Pharmanovia
Full time- 2+ years
- Not Disclosed
- Mumbai, India
- Post Date: May 03, 2024
- End Date: Jul 03, 2024
- 2+ years
- Not Disclosed
- Mumbai, India
- Post Date:May 03, 2024
- End Date: Jul 03, 2024
Skills:
- Operations
- Clinical Trial
- Inspection
Job Description:
Responsibilities
- Responsibility for ensuring that the Sponsor Oversight File (SOF) and/or the Trial Master File (TMF), to include electronic TMFs, is complete and accurate on an ongoing basis and ready for archiving according to timelines
- Performing/overseeing periodic QC of SOFs and/or TMFs at Pharmanovia to ensure completeness and accuracy
- Performing QC of any TMF maintained by Service Providers (SPs) during and at the end of a study as well as an evaluation of the SPs TMF processes before study initiation
- Maintaining and updating any electronic study folders to ensure eFiles reflect any paper TMF/SOF and vice versa
- Support with clinical archiving to ensure timely coordination of archiving study documentation.
- Arranging and participating in the organisation of Investigator Meetings & Study Team Meetings (internal and external), preparing agendas and taking (where appropriate) and distributing minutes as required
- Coordinating any study document reviews where required
- Assisting with the Ethics submissions; keep a track of submissions & approvals for the study. Liaise with Regulatory Affairs to ensure linkage with regulatory approvals
- Printing, distributing and tracking of any study specific documents internally and to any SPs
- Creating and maintaining study contact lists and relevant information databases for study team
- Sending out Study Newsletters / Study Correspondence to all participating SPs/sites on an ongoing basis
- Facilitating and tracking any study payments following the internal approval process
- Facilitating the obtaining and maintenance of study insurances
- Conduct oneself at all times in accordance with Pharmanovia Quality Management System, company working practices and policies, applicable GxP regulations ensuring training in these areas is kept up-to-date at all times
- Assisting with the company's Clinical Quality Management System:
- Reviewing, updating and expanding Standard Operating Procedures and associated documents, policies, and manuals
- Ensuring staff are aware of the most recent versions of QMS controlled documents
- Reviewing staff training records to ensure they are kept up to date
- Ensuring learning and knowledge transfer during and at the completion of the trial(s)
- Any other duties as required by the Head of Clinical Development and Chief Scientific Officer as well as assisting the wider Scientific Affairs organisation in activities other than those specified above
- Some manual lifting is required within this job role e.g., moving files, archiving files, lifting boxes, carrying items from loading bay and around the office
Qualification & Experience
- Candidates who have previously worked as a Clinical Trial Associate and/or Document Manager in clinical research or pharmaceuticals are likely to have the skills required to be successful in this role. We are also looking for:
- Bachelor's degree in life sciences, pharmacy, health sciences, nursing or equivalent
- Great IT skills including MS Office programs, and an aptitude for/interest in bringing in electronic systems
- Previous experience within clinical research/trials and good knowledge of the whole trial process
-
Salary
Not Disclosed
-
Role
Associate
-
Area of Practice
- Clinical Operations
-
Experience
2+ years
Remove this line later