Job as Senior Scientist -Clinical Development in Biocon

Biocon is a research-driven, global healthcare company with a strong matrix of capabilities along the biopharmaceutical value chain. Focusing on unmet medical needs in cancer, diabetes and inflammatory diseases, it offers novel therapies on a platform of affordable innovation.
Biocon together with group companies employs more than 2500 employees with approxmimately Rs 1,000 crore turnover and is expected to grow further during the current financial year.

Post: Senior Scientist -Clinical Development - HC/JC/3678/2013

Job Description:
· Monitors clinical trials to ensure adherence to Good Clinical Practices in accordance with ICH-GCP standards, Declaration of Helsinki, Applicable regulations and guidelines as well as Study procedures
· Reads all applicable SOPs and attends trainings as recommended
· Assists in development of study protocols, Informed consent forms, Case report forms (CRFs) and other study documents as per requirements
· Compiles documents and coordinates for regulatory/competent authority applications
· Assists the Project Manager in coordination activities with the CROs, any third parties and vendors

· Addresses comments raised by sites regarding clinical trial agreements both in terms of legal and financial aspects and discusses internally and/or with sites (as applicable) to achieve mutually agreed outcome
· Ensures the timely submissions of essential study documents for EC/IRB approvals
· Assesses the suitability of study sites which includes availability of laboratories, equipments, adequate storage space, resources etc. as per requirements
· Ensures that the Investigators and their staff are qualified and trained to conduct the study
· Assists majorly in organizing and conducting investigator meetings which would include preparation, liaison, presenting, problem resolutions and follow up
· Liaises with Medical Monitor, Internal personnel involved in the study, CROs, Investigators, Suppliers and any other Vendors as and when required
· Build and maintains contacts with investigators and third parties ensuring a smooth conduct of the study
· Assists the Project Manager in review and verification of study expenses by checking invoices received for the study
· Ensures through discussions and documents that for the investigational product(s) storage times and conditions are acceptable, and study supplies are sufficient throughout the trial
· Ensures that the investigators receive the current Investigator’s Brochure, all documents, and all trial supplies needed to conduct the trial properly and to comply with the applicable regulatory requirement(s)
· Tracks recruitment across assigned sites, identifies key issues with slow recruiting sites and updates the Trial/Project Manager for suggestions/taking corrective actions, hence, ensuring study recruitment target as per/within timelines
· Monitors the trial throughout its duration by reviewing regular study updates, trackers, documents as well as patient data from the study sites, by attending study teleconferences and/or meetings and by performing site visits/co-monitoring visits

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Candidate Profile
•Knowledge of GCP guidelines, national as well as international regulations applicable for clinical trials, medical terminology and clinical trial processes
•Comprehensive knowledge and understanding of the drug development process
•Significant training/experience in performing a Clinical Research Associate role
•Ability to contribute in development of clinical trial related documents and materials
•Willingness and ability to travel including international travel

Additional Information:
Experience: 3-4 Years
Location: Bangalore
Education: B.Pharm, M.Pharm, MBBS
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: R&D
End Date: 12^th Jan., 2014