General Manager Operations and Project Clinical Trails

Responsibilities

• Managing Clinical Trial Sites for a SMO with over 20 sites
• Planning, implementation and maintaining an overview of clinical studies for a leading Healthcare chain. Completion of Clinical Trials with compliance to regulations, guidelines and SOP as needed
• Manage clinical studies within allotted budget, timelines and maintaining highest quality.
• Guiding and training the Trial Managers, Trial Administrators, EC Administrators, Clinical Research Coordinators and Assistants & Course Administrators.
• Coordinating and liaison with the hospital management, physicians, sponsors, regulatory agencies and patients, as needed
• Ensuring 100% patient recruitment and retention in the clinical studies in compliance to GCP and regulations
• Organizing and overseeing staff training programs, periodic site team meetings and review meetings
• Optimizing cost and resources to improve organizational profitability
• Future diversification of services of the SSO.

Skills and expertise required

• Thorough understanding of drug development process and expertise in NDCT rules & ICH-GCP/Indian GCP
• Knowledge of clinical trial regulations of US FDA, EMEA, NDCT rules, ICMR guidelines, etc
• Effective and assertive communication skills
• Good leadership qualities and skills

• Auditing all the areas like Clinical, (Hospital clinical sites) Clinical Laboratory, Bio-analytical (Instrumentation) and Pharmacokinetic & Biostatistics, third party service providers and Global Pharmacovigilance area in India and abroad.
• Managing the projects for timely start and completion of the project and Planning / scheduling of projects.
• Well versed in development of Standard Operating Procedures (SOPs)
• Well conversant with guidelines of various regulatory agencies, like ICH-GCP, ANVISA (Brazil), USFDA, UK-MHRA, WHO, MCC, ANSM, Applicable 21 CFR Parts, OECD- GLP…etc.
• Monitor and hasten the progress of all ongoing projects and provide directions for future projects.
• Recognized for outstanding job performance, reliability, multitasking skills, efficiency, accuracy, speed, and timely completion of all assignments.

• Responsible for Quality and compliance of entire Clinicals with respective to all Clinical trial sites, Bioanalytical area, In-house Clinical facility, Clinical Data management, Pharmacokinetic and Biostatical, Statistical programing area, medical writing, and all the relevant computer system validations.
• Clinical Trial protocol review, Site qualification audit, Interacting in Site initiation, Review of site monitoring reports, TMF review, Performance of UAT for eCRF, source data template review, SAP Plan review, CDISC data set review.
• Experience in various therapeutic clinical trials of PK & PD Studies like Psychiarty, Gastroenterology, Respiratory, Dermatology, Oncology, Biosimilar(s), etc..
• Responsible to overseas the entire training process for all the employees.
• Responsible for identification and qualification of the vendor for the suitability of outsourcing the required activities.
• To manage the functions of GCP/GLP Quality Assurance program that will assure that all clinical studies conducted can withstand regulatory scrutiny.
• Review and approval of SOPs and Manuals to define internal systems and procedures as per the Quality Policy.
• To manage / Hosting Regulatory inspections for GCP/GLP inspections of different regulatory bodies like USFDA, WHO, Brazil, UK-MHRA, …etc. and sponsor audits at various clinical sites as well for Bioequivalence studies.
• To develop, perform, and manage an auditing program that compasses all phases of studies.
• Documentation and record-keeping requirements are met internally to support regulatory submissions.
• Coordinate with all the cross functional heads for periodic Quality Management Reviews to ascertain the compliance status to management.
• Evaluation and approval of Change Controls and Deviations.
• Responding to queries from various sponsors and regulatory authorities.
• Developing the audit system to look after the studies with respective to In-process, Retrospective audit, Internal and External audit programmes to continues overseas of the quality system.
• Responsible in compilation and submitting the M5 module eCTD to various regulatory / sponsor.

• Proficient in developing clinical strategy / clinical development plan for studies for R&D products.
• Responsible for design and conduct of Clinical trials and BA/BE studies for Shilpa Medicare limited for small and large molecules.
• Handling of regulatory deficiency on dossiers submitted.
• Expertise in providing inputs in Protocol, Informed consent form (ICF) Clinical Study Report, Clinical & Non-Clinical Summary, Regulatory deficiency Responses and CRF.
• Handling of various regulatory inspections related to clinical affairs division of Shilpa Medicare Limited and its affiliated companies.
• Monitoring of the Clinical studies outsourced.
• Preparation of Biowaiver/Scientific justification for biowaiver for lower strengths.
• Representing management review meetings for Clinical affairs division.

Identifying CMA of drug substance and excipients, critical formulation components and critical process parameters that are expected to affect BA/BE