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Work as Project Manager in Clinical Operations @ Bicon

Biocon is an integrated biotechnology enterprise focused on the development of biopharmaceuticals. With successful initiatives in drug discovery and development, bioprocessing, manufacturing and global marketing, Biocon delivers products and solutions to partners and customers in over 75 countries. Biocon has the defining science, world class capabilities and a focused vision to deliver the promise of innovative and affordable medicine to a waiting world. Today, Biocon together with group companies employs more than 5000 employees with approxmimately Rs 2500 crore turnover and is expected to grow further during the current financial year .

Job Title – Project Manager – Clinical Operations

No.of.Posts – ONE

Experience – 5 – 10 Years

Location – Bangalore/Bengaluru

Qualifications – M.Pharma

Job Description:

1. Develop budget and timelines as per the CDP from the inception stage of the project
2. Identification and selection of appropriate CROs through review of proposals and onsite selection visits and participate in CRO biding process
3. Identification and selection of appropriate third party study vendors
4. 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
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. Negotiate and manage the budget and payments for investigative sites, as applicable
9. 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 all clinical activities/project deliverables within the required time frame and budget
10. Prepare robust CRO oversight plan and escalation path to follow when needed

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