Ajay Shinde

• Assisted in monitoring and maintaining equipment functionality to ensure operational efficiency.
• Supported compliance with safety regulations and protocols within the workplace environment.
• Collaborated with team members to uphold quality standards in daily operations.
• Mentored junior staff members on proper monitor usage techniques and troubleshooting strategies for common issues encountered during daily operations.
• Utilized advanced software applications for efficient data management and analysis, contributing to improved overall workflow efficiency.
• Contributed to the development of monitoring policies and procedures, promoting a standardized approach across all units.
• Participated in quality improvement initiatives aimed at enhancing patient safety and satisfaction within the facility.
• Provided comprehensive support during clinical trials, ensuring adherence to protocols and data collection accuracy.
• Maintained strict compliance with all relevant regulatory guidelines and industry standards to uphold the integrity of patient monitoring processes.
• Identifies new potential Investigators, through ongoing collaborations with internal and external stakeholders.
• Assesses potential Investigators and their sites to ensure they have the resources and capabilities to conduct clinical trials.
• Develop Site relationships.
• Recommends sites during the site feasibility and/or site selection process Conducts pre-study visit as appropriate.
• Conducts initiation visits to ensure Investigator and site personnel receives adequate protocol specific training prior to site activation.
• Reviews site activities and quality through on-site and off-site visits. Conducts monitoring activities and ensures safety and protection of study subjects as per the monitoring plan, BMS procedural documents, protocol, ICH/GCP Guidelines and other local regulations as applicable.
• Perform Unblinded Site Monitor activities to protect the blind of the study by acting as secondary monitoring source separate from the blinded monitor.
• While monitoring demonstrates the ability to use data to assess risks, identify issues and make appropriate decisions.
• Serve as a point of contact for Sites
• Provides trainings to sites
• Performs site closure activities when all required protocol visits and follow-up are completed
• Manages multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
• Ensures completeness and quality of data submitted from study sites.
• Ensures eCRF data is available and current by using the available systems to follow site activities.
• Oversees activities of site personnel over whom there is no direct authority.
• Motivates/influences the site to meet study objectives, including enrolment and retention goals.
• Demonstrates flexibility and adaptability when communicating with different stakeholders utilizing the most appropriate communication method
• Anticipates, identifies and proactively supports site in resolving issues as they occur. Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team. Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective/preventive actions based on root cause analysis are implemented
• Involvement in Regulatory Compliance audit/inspection process, as needed. This includes the development and implementation of site corrective and preventive actions
• Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise, professional and objective manner
• Being Aid in Ethics Committee submission, ICF review, collection of documents to/from site, ensuring access to eDC and vendor systems is available for clinical trial site personnel, equipment calibration and tracking, preparation of Study Initiation Visit materials, coordination and ensure database lock timelines are met as required locally

• Identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site.
• Liaising with doctors/consultants or investigators, global vendors and global team on conducting the trial.

• Coordinated clinical trial activities to ensure compliance with regulatory requirements and protocols.
• Monitored patient recruitment efforts, providing strategic guidance to enhance enrollment rates.
• Trained junior staff on clinical monitoring techniques and regulatory standards, fostering team growth.

•Customization of ICF as per local regulatory guidelines and SOP for country and site specific ICF.
• Perform site visits i.e., site feasibility visit, site initiation visit, site selection visit, interim monitoring visits and
close-out visit.
• Interim Monitoring Visit by adhering to monitoring plan.
• Mentoring colleagues by sharing best practice and training.
• Facilitate site for readiness for SIV with respect and budget approval.
• Facilitate preparation/collection of site level documents and clinical supplier management.
• Setting up the trial sites, which includes ensuring each centre has the trial materials, including the trial drug
often known as the investigational medicinal product. Training of study staff on standard operating
procedure for the clinical trials as per applicable regulatory requirements. Verify that investigator and
investigator's team are adequately trained and comply with the protocol.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness. Reconciles
contents of the ISF with the Trial Master File (TMF).
• Verify that IRB/IEC operates and complies as per GCP, SOP and applicable regulatory requirements.
• To perform source data verification by comparison with source data or documents in eCRF.
• Informed consent form review, case report form review, investigational drug accountability, and adverse
event review.
• Preparation and maintenance of site monitoring finding, Collection of trial documents and action plans by
submitting regular visit reports.
• Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other
required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports
subject/patient recruitment, retention, and awareness strategies.
• Managed clinical trial on the indication like Oncology, Gene therapy, Neurology, Cardiovascular,
Neurology, Nephrology, Dermatology system.

Perform international monitoring at Jordan.

• Designed and implemented monitoring plans for clinical trials, ensuring compliance with regulatory standards.
• Coordinated site visits and conducted training sessions for site staff on study protocols and procedures.
• Reviewed and analyzed clinical data to identify trends, discrepancies, and areas for improvement.
• Preparation and maintenance of site monitoring finding and action plans by submitting regular visit reports.
• Recruitment tracking, IP tracking and payment tracking.
• Perform international monitoring at Jordan.
• Perform monitoring of phase trial on the indication like Oncology, Neurology, Cardiovascular system.

• Developed and implemented recruitment strategies to enhance participant enrollment in studies.
• Collaborated with cross-functional teams to streamline project timelines and improve workflow efficiency.
• Trained and mentored junior staff on best practices in clinical research methodologies.
• Managed data collection processes, ensuring accuracy and integrity of clinical trial data.
• Facilitated communication between investigators, sponsors, Institutional Ethics Committee and regulatory agencies to support project objectives.
• Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and regulations.
• Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
• Gathered, processed, and shipped lab specimens.
• Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
• Followed informed consent processes and maintained records.
• Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
• Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
• Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
• Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
• Maintained compliance with protocols covering patient care and clinical trial operations.
• Managed patient recruitment, informed consent process and data entry to support trial objectives.
• Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
• Prepared and maintained regulatory documents for clinical trial submissions .
• Reduced data entry errors by implementing stringent quality control measures throughout the study lifecycle.
• Developed strong relationships with trial sponsors, ensuring ongoing collaboration and future project opportunities.
• Aid in negotiation and finalization of Clinical Trial Agreement between sponsor and/or CRO and Institution
  based upon protocol. To check payment details against actual payment made by the sponsor/ CRO.
• Maintain and update Site Master File.

• Oversaw medication dispensing operations, ensuring accuracy and compliance with regulations.
• Mentored junior pharmacists and pharmacy technicians, enhancing team competency and performance.
• Developed and implemented patient counseling protocols, improving medication adherence and outcomes.
• Collaborated with healthcare providers to optimize pharmacotherapy plans tailored to patient needs.