Job title: MANAGER
Company: Biocon
Job description: Role Summary
As Clinical Project Manager, the person is responsible for conducting clinical trials as per applicable regulations and GCP in out-sourced model. He/ She is responsible for identification of CRO/ vendor, over-sight of activities performed by CRO. Manages internal and external stakeholders and communicate to management on the progress of the trial. He/ She is also responsible for timely deliverable with stipulated budget.
Key Responsibilities
1. Identification and selection of appropriate CROs through review of proposals and onsite selection visits and participate in CRO biding process
2. Identification and selection of appropriate third party study vendors
3. Oversee performance of CROs, third party vendors, including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate CRO or to seniors as appropriate
4. Prepare robust CRO oversight plan and escalation path for outsourced trials
5. Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures
6. Track and report on progress of study including site activation, patient enrollment, monitoring visits etc
7. Monitor progress of trial and timelines as per the milestones and implement appropriate action plans in case of delays
8. Perform co-monitoring at sites to ensure compliance of the investigator to trial protocol and regulations
9. Negotiate and manage the budget and payments for investigative sites, as applicable
10. Co-ordinate closely with the clinical development team and other cross-functional representatives, including Biostatistics, Pharmacovigilance, Regulatory/QA, formulation team, programe management etc. to ensure successful completion of clinical activities/project deliverables within the required time frame and budget
11. Prepare robust CRO oversight plan and escalation path to follow when needed
12. Prepare/review Trial master files for the trial assigned
13. Prepare SOPs when required
Educational Qualifications
Required Education Qualification: Master of Science
Required Experience: 10 – 12 years
Expected salary:
Location: India
Job date: Fri, 18 Feb 2022 08:40:42 GMT
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