• Clinical trials management including Clinical/Medical input in the device design, functionality, usability, Safety, accuracy, risk management and Data management.• Key contribution in the protocol development, trial design, schedule of assessment, ICF development, safety plan, DSMB charter, Data management plan, CRF development eCRF completion guidelines.• Collaboration and interaction with domestic as well as international Sponsors and vendors ( EU, China, Poland, Japan etc.…) in running the clinical trials in terms of specific regulatory requirements, UG/QRG/Labelling development, site qualification, site activation/initiation, enrollment, data collection, safety event reporting, quality data management and vendor’s management.• Develop a strong and meaningful collaboration with sponsors, CRO’s, sites and vendors to work on realistic goals and timelines such as FPFV, LPLV, database lock, Interim Analysis, to make sure that the study is on the track and completed on time.• Constant contribution in the development of contracts and budgets, site negotiations, CRA’s management, monitoring plan, co-monitoring, and review of safety narratives, safety database and reports, monitoring reports.• Member of Global Product Team (GPT) daily, weekly and monthly calls with global team to review the timelines and progress of the current projects and support in completing the action items assigned from these meeting.

• End to End Clinical trials management including Safety and Data management as Associate Director.• Key contribution in the protocol development, trial design, schedule of assessment, ICF development, safety plan, DSMB charter, Data management plan, CRF development eCRF completion guidelines.• Collaboration and interaction with domestic as well as international Sponsors and vendors in running the clinical trials in terms of site qualification, site activation/initiation, enrollment, data collection, safety event reporting, quality data management and vendor’s management.• Develop a strong and meaningful collaboration with sponsors, CRO’s, sites and vendors to work on realistic goals and timelines such as FPFV, LPLV, database lock, Interim Analysis, to make sure that the study is on the track and completed on time.• Manages contracts and budgets, site negotiations, CRA’s management, monitoring plan, co-monitoring, and review of safety narratives, safety database and reports, monitoring reports.• Put together a communication plan and training /Education plan within the company as well as outside customers, vendors and study sites, DSMB members to make sure all the key players are on board to the success of the trial.

• Clinical trials management as an International Clinical Trial Manager (ICTM) for a leading pharmaceutical Company.• My responsibilities were to provide Project management support to all 4 Global trials.• I also provided support to the scientific and clinical aspects of the trials in terms protocol development, ICF development, Amendments, IB, CTR, CTA.• Contributed in the development of recruitment materials, safety data review, study monitoring management, CRO management, vendors’ management.• I also support team in the preparation and submission of studies at the country level.• Support in the site selection process, CTA and budget negotiation, training and education, answer clinical and protocol related questions.• Review study events reports, create and review narratives, and analyses the relationship with procedure and study drug/devise and recommend for adjudication, review and analyses safety data.

• End to end management of a clinical trial process from protocol development through study reporting • Support internal and external customers in drafting study documents such as protocols and ICF, etc…• Working knowledge of handling clinical project budgets and ensure completion to final reporting for both submission studies and exploratory work• Experience in matrix structure, driving delivery of clinical studies within project teams • Experience with internal/external customers to coordinate internal/external resources for clinical trial planning• Able to mentor, recruit, train, and supervise contract CRA’s and new sites for specific Research Projects and patients enrollment • Guide and assist sites in the preparation of Regulatory documents • Support sites for IRB submission of protocol, ICFs and contract negotiation• Site initiation visit to inform the physicians about protocol and study logistics• Educate and train the research team, pharmacists, and nursing staff of ED, CCU, and Cath Lab• Specific education to SC with ref. to screening/consenting process, randomization process, and study drugs, procedure coverage, CRF’s, source docs for SAE’s and PD• Site re-in-services and interim monitoring to follow-ups study progress and to address any specific issues• Review monitoring reports, follow-ups on action plans, create new ideas and tools to help Internal Regulatory team for QC process and help sites to run studies according to regulation• Coordinates CRO, SC, and sponsors in day to day operations of study enrollments• Provide global support to the Medical Affair team to answer protocol and clinical related questions and issues from the sites, PI, SC, and CRO’s• Coordinate, communicate and negotiate all venders for study supplies, sample collection and created a database for the final Analysis

• Provided support to physicians in coordinating Phase II, III and IV clinical trials• Recruited, screened and managed patients participating in clinical trials of different therapeutic areas• Supervised drug dispensing, inventory and accountability; data analysis; performed an interoffice monitoring of case report forms and interacted with study monitors• Prepared all necessary documentation for IRB/ FDA submission, budgets for upcoming studies, and assisted in protocol preparation• Successfully prepared and conducted several FDA audits • Assisted in accumulating data for writing abstracts and reports for a variety of research projects• Participated in clinical investigator meetings and poster presentations • Created all study related status reports and source documents• Produced and established Standard Operating Procedures for new research coordinators• Trained research staff with regards to GCP’s, ICH, and Federal regulations and day-to-day laboratory operations• Provided trouble-shooting services various clinical studies and protocols interpretation

• Analyzed and processed a variety of Microbiology specimens in the laboratory• Performed pre-surgical procedure testing, including phlebotomy for blood culture, EKG, glucose tolerance tests & HIV tests