Rajesh Gaikwad Email and Phone Number

-> Clinical Trial Management: Overseeing all aspects of clinical trial conduct, including protocol development, site selection, patient recruitment, monitoring, data management and regulatory compliance. -> Vendor Management: Managing relationships with external vendors, central laboratories, and other service providers, ensuring quality, performance, and compliance with contractual agreements. -> Regulatory Compliance: Ensuring compliance with applicable regulatory requirements, including DCG(I), FDA, EMA, and ICH GCP standards, throughout the clinical trial lifecycle. This includes maintaining documentation, conducting audits, and addressing regulatory queries. -> Quality Assurance: Implementing quality management systems (QMS) and processes to maintain compliance with quality standards, SOPs, and best practices. Ensure data integrity and patient safety through rigorous quality control measures. -> Monitoring and Reporting: Monitoring key performance indicators and milestones for clinical trial progress, prepare regular reports and updates for senior management and stakeholders, and provide strategic recommendations based on data analysis and insights

-> Possessed expertise to deliver projects within the committed time & cost parameters with tracking performances (metrics); demonstrated ability to direct and motivate teams to complete projects meeting specifications -> Demonstrated excellence in interacting with clients/CROs, developing RFIs and RFPs etc. -> Instrumental in handling the complete resource management; ensuring the timely arrangement of resources -> Identified business opportunities and leverage competencies to drive growth, reduce costs, improve market positioning and strengthen bottom-line performance -> Improvised, assessed complex problems; successfully developed and ramped-up fast practical solutions to meet immediate need in the processes -> Monitored progress of all trials (In-house & Outsourced) on an ongoing basis relative to established timelines and key milestones. -> Participate in and facilitate efforts to implement appropriate interventions across functional groups to meet timelines -> Managed and directed the efforts of study team and recommend personnel actions including, but not limited to performance management, scheduling and work assignments, disciplinary action, promotions etc. -> Reviewed the quotes of Vendors/CRO’s & also prepare budgets for in-house and outsourced studies -> Monitored the status of expenditure for the in-house studies and outsourced studies and provide a monthly update to the Senior Leadership Team

-> Monitored the progress of all trials (In-House & Outsourced) relative to established timelines and key milestones. Participate in and facilitate efforts to implement appropriate interventions across functional groups in order to meet timelines Line management of assigned team members -> Provided key clinical operational inputs & liaise with the Medical Services team to finalize the clinical protocol, Informed Consent Forms (ICF’s), clinical development plans, medical monitoring plans -> Vendor identification, development and management & implementing new setups -> Reviewed the quotes of Vendors/CRO’s and provide feedback -> Carried out SOP review and implementation

-> Responsible for coordinating the planning, development and implementation of clinical protocol, administrative and logistical procedures, documentation and operating systems. -> Managed global regulatory submissions and approvals. -> Performed site compliance visits. -> Prepared structure of project specific communication plan including an escalation process for fraud, misconduct, SAEs etc. -> Handled sponsor audits/regulatory inspection for assigned projects. Prepare all study sites for internal, Sponsor audits and/or Regulatory inspections. -> Assisted the Head of Clinical Operations in business development activities like attending industry seminars and conferences, preparing presentations and bidding for prospective clients/sponsors

-> Site Selection and Qualification: CRAs participate in the selection and qualification of investigative sites for clinical trials. This involves evaluating site capabilities, assessing adherence to protocols and regulations, and ensuring that sites have the necessary resources and expertise to conduct the trial effectively.-> Study Start-Up Activities: CRAs assist in the initiation of clinical trials by coordinating with investigative sites to ensure all essential documents and regulatory approvals are obtained. This includes preparing and reviewing study documents such as protocols, investigator brochures, and informed consent forms.-> Site Monitoring and Management: CRAs conduct regular visits to investigative sites to monitor the progress of clinical trials and ensure compliance with protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. This involves reviewing study documentation, verifying data accuracy, and addressing any issues or deviations that may arise.-> Data Collection and Review: CRAs oversee the collection and management of clinical trial data, ensuring accuracy, completeness, and timeliness. They may also assist in data review and query resolution to ensure data quality and integrity throughout the trial.-> Safety Monitoring: CRAs are responsible for monitoring the safety of trial participants and ensuring that adverse events are reported and managed according to protocol and regulatory requirements. This involves reviewing safety data, assessing risks, and communicating with investigative sites and study sponsors as needed.-> Quality Assurance and Compliance: CRAs ensure that clinical trials are conducted in compliance with applicable regulations, guidelines, and quality standards. They may participate in internal and external audits to assess and address compliance issues and ensure the integrity of trial data.