Job Description
President
Major purpose of the Job: Overall responsible for CRO. To set & monitor the objectives and targets of all the departments. To review the progress of the organization and ensure continuous growth. To monitor corrective action relating to planning process and quality management system of departments. To co-ordinate with statutory and regulatory bodies to comply the related provisions. To guide and direct the staff of various departments towards optimum utilization of resources and to provide resources as required. To manage day-to-day operations. To implement the guidelines / instructions provided by various regulatory agencies as applicable. Job Responsibilities: 1. Visionary Goals: To be one of the top ten CROs in India. To transform the CRO unit into a world class Bioequivalence and Clinical Trials center. 2. Functional Goals: To ensure proper and timely operations of all activities within the CRO. To conduct bioequivalence studies in the financial year. To meet the budgeted revenue for the financial year. To ensure CRO meeting customer satisfaction and customer relationship. To interact with various regulatory bodies for audits and trial applications To coordinate with the new drug development program of Cadila Pharmaceuticals and conduct required number of BA/BE and Clinical Trial studies. To coordinate with the ANDA program of Cadila Pharmaceuticals and conduct required number of BA/BE and Clinical Trial studies. To conduct project specific training. Administration of facility and evaluation of systems and people to improve quality and productivity. To oversee all operational/scientific aspects in the area of Clinical research, Toxicology and Pharmacovigilance of Cadila Pharmaceuticals. 3. System Improvement Goals: Systems Application and upgradation of the facility at R&D to be in line with the requirements of ICH-GCP and GLP. Guiding and development systems to meet GCP/GLP and other regulatory requirement. Providing equipment/infrastructure in required number to deliver the jobs assigned. Data management: To establish an integrated data management system for bioequivalence and clinical trials. To implement a thorough quality assurance system throughout the bioequivalence and clinical trial areas. Training, continuing education and development of staff to be able to meet CRO requirements for conducting International business. 4. Cost Optimization Goals: To submit financial position of organization to concerned authority. Financial / budgetary planning for CRO To monitor cash flow. Helping Business Development team with inputs for getting and maintaining clients. To ensure that R&D shows substantial savings in all areas by thorough planning, avoidance of rework and maximizing the output of individual scientist by giving them appropriate guidance and directions. To plan projects for current financial year. 5. Employee Development Goals To implement all rules and regulations framed by CRO for administrative purposes. To fulfil the requirement of CRO for recruiting, promoting and training the staff and changing the administrative controls of staff for better control and output. To implement & circulate new revisions related to rules, regulations, policies etc. within the organization. To keep the attrition rate at CRO