Job id : 61420
Clinical Development(Biocon Biologics)
Clinical Development(Biocon Biologics)
Bangalore
3 years ago
23 Applied
JOB ID:61420
Job details
Job Type
Full Time
Functional Area
Pharmacist/Bio-Technologist,RnD/Engineering design
Industry
Pharma/Biotech/Clinical Research
Education
Not Specified
Experience Required
6 - 15 Yrs
Key Skills Required
clinical trial project management
Other Skills Required
Languages
English
Job Description
1. Identification and selection of appropriate CROs through review of proposals and onsite selection visits and participate in CRO biding process2. Identification and selection of appropriate third party study vendors3. Drive the selection of CROs, vendors in the conduct of outsourced multinational clinical trials4. Develop budget and timelines as per the CDP from the inception stage of the project5. Manage program budgets and track overall quality on multiple clinical trials6. Give strategic inputs to improve qualiy and efficiencies through quality management plans.7. Driving clinical trials independently across various geographies8. 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 to CRO or seniors as appropriate9. Prepare robust CRO oversight plan and escalation path for conduct of the trial10. Ensure studies are carried out according to the... See More
1. Identification and selection of appropriate CROs through review of proposals and onsite selection visits and participate in CRO biding process2. Identification and selection of appropriate third party study vendors3. Drive the selection of CROs, vendors in the conduct of outsourced multinational clinical trials4. Develop budget and timelines as per the CDP from the inception stage of the project5. Manage program budgets and track overall quality on multiple clinical trials6. Give strategic inputs to improve qualiy and efficiencies through quality management plans.7. Driving clinical trials independently across various geographies8. 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 to CRO or seniors as appropriate9. Prepare robust CRO oversight plan and escalation path for conduct of the trial10. Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures11. Track and report on progress of study including site activation, patient enrollment, monitoring visits etc12. Monitor progress of trial and timelines as per the milestones and implement appropriate action plans in case of delays13. Negotiate and manage the budget and payments for investigative sites, as applicable14. 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 project deliverables within the required time frame and budgetEducational Qualification:M Pharm, M.Sc or any other equivalent degree in life scienceTechnical/Functional Skills:Well versed with guidelines of various countries like USFDA, EMEA, India, ICH-GCP, GLP, GMP etc.At least 6 yrs experience in Clinical trial project Management across multiple geographies Desired skills and competencies:Good interpersonal skillsAbility to build cross working relationships with other functions within companyExcellent verbal and written communication skillsStrong desire to take ownership of multiple projectsAbility to adapt to changes in the work environment, method or approach See Less
Requirements
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Responsibilities
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Company Benefits
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About Company
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