Tech Observer
Location
Mumbai | India
Job description
Tech Observer is a Global CRO, FSP solution provider and US Staffing Company. Established in 2005 with its HO in NJ, USA and presence globally (India, Singapore, UK, Europe and business partners)
We are hiring for Leadership level in Clinical Operations to head our local and global studies and Teams in APAC. Location : Mumbai/Noida/Ahmedabad/Hyderabad Job Description: *Responsible and accountable for the conduct of clinical trials and functioning of the Clinical Operation/Project Management/Site Management Team ensuring all projects are reviewed periodically and completed as per the accepted/agreed timelines. Regular interactions with internal teams and Sponsors to keep a tab on the requirements. *Oversee, lead, and manage cross-functional team resources and external service providers to conduct trials on time, on budget, in compliance, and of highest quality. *Identify, evaluate and manage all external vendors. Take initiative to continually monitor each external vendor in performance management, escalate issues where appropriate, and make the appropriate changes in order to ensure trial conduct is completed in compliance and meets company’s business objectives. *Responsible for Reviewing RFPs before the final submission to Sponsors, provide comments on the same *Responsible for writing, Reviewing and approving all study-related Clinical documents. *Responsible for Team management with proper and regular training to the team on relevant topics. Ensuring skill enhancement with time management skills to meet internal/ external timelines. *Oversee the development of presentations, handouts, and coordination of Investigator Meetings. *Work with appropriate team members to ensure that all TMF-related documentation is current, on-file at respective sites and sponsor locations throughout trial conduct. Notify and prepare team for regulatory agency audit and address any audit observations appropriately and in a timely manner. *Proactively monitor and report trial progress and performance, timelines, and financial metrics on an ongoing basis to the management team, including current status of study milestones and forecast budgetary requirements based on scope of work. *Ensuring proper documentation as mandated by but not limited to applicable regulations, ICH GCP guidelines so as to be at par with other Organizations and be audit-ready for Sponsors *Identifying potential projects and other issues, suggesting and implementing the solutions for the and same. *Providing guidance to Clinical Operations & other teams from time to time on topics relevant to the conduct of Clinical research activities. *Development of documents, identify any gaps in a company's documents for e.g. SOPs, Work Instructions, Plans, Policies etc. and facilitate development of the same as needed. *Responsible for Initiating 'Risk and Contingency Plan' before risks arise and implementing plans/triggers appropriately demonstrate the ability to manage multi-service and/or cross-functional medium to large/complex projects in accordance with timelines and budgets. *Responsible for Demonstrate expertise to prepare and handle audits (both internal/ external/ sponsor) &/or inspection and follow through till CAPA resolution.). *Identify, qualify, manage, and maintain relations with clinical trial sites, including collaborating with Principal Investigators and field teams on developing robust study plans, drive site selection, and patient recruitment programs that deliver enrolment targets. *Responsible for Part of the Senior Management. Provide strategic inputs to the Organization for ethical functioning of the Teams. *Responsible for Connect with colleagues and peers in the Industry to promote the experience and expertise of Tech Observer and be the preferred partner for their Clinical Research activities. *Responsible for Representing Tech Observer in Industry forums to improve networking and contribute to the development of Clinical research in the country. *Responsible for Supporting Business Development team to establish contacts with Sponsors for conducting Clinical research activities in varied segments like Pharma, Medical Devices, Nutraceuticals, vaccines etc. *Responsible for Hiring process for team members in Clinical Operations / Project Management /Site Management as well as other departments as requested by the senior management. *Any Other responsibilities as assigned by Reporting Head and / Senior Management.Job tags
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