Krishna Maurya Email & Phone Number

Gandhinagar, Gujarat, India

• Develop comprehensive project plans, including budgets, timelines, resource allocation, and risk assessments.• Allocate and manage project resources efficiently to meet project milestones and deliverables.• Monitor project budgets and expenditures, making necessary adjustments to stay within budgetary constraints.• Ensure that clinical trials progress according to planned timelines and milestones.• Identify potential project risks and develop risk mitigation strategies.• Lead cross-functional teams, setting clear objectives and timelines for the successful execution of clinical trials.• Collaborate with sponsors, clients, and internal teams to ensure clear communication and alignment on project goals.• Address any project-related issues promptly, working with teams to find solutions and ensure project success.• Contribute to the preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research-related documents.• Ensure clear and consistent communication with all stakeholders throughout the project lifecycle.• Monitor industry trends and regulatory changes to ensure continuous compliance and process improvements.

India

• Conduct all clinical site activities according to the monitoring plan and in accordance with the study timeline and company objectives.• Build and maintain a high-performance team of monitoring staffs.• Functioned as the primary point of contact between CRO and the management.• Solely responsible for the management of all the ongoing clinical trial projects of the company.• Acts as a member of the project team with the goal to contribute towards efficient management of trials.• Negotiates investigator budgets and assists with the execution of site contracts with support from the Research Team.• Communicates effectively with site personnel, including the Principal Investigator (PI), and site staff to relay protocol/study deviations and ensure timely implementation of corrective actions.

Ahmedabad

• Performs pre study visits: discusses protocol, other available study documentation and study requirements with Investigator and other trial staff, ensures that trial staff and site facilities and the site’s recruitment potential are in accordance with protocol requirements, local regulations, ICH-GCP. • Performs initiation visits: trains Investigators and other trial staff in the protocol and data collection methods to ensure collection of patient data is accurate, complete, and conforms to protocol requirements, in accordance with local regulations, ICH-GCP.• Performs monitoring visits: ensures adherence to protocol, accurate data collection via comprehensive source document verification, and investigational product/biological samples/supplies accountability. Also Performs Co- monitoring activities to provide oversight of CRO performance.• Prepare Trial Master File (TMF) for the trial as well as an investigator file for each investigator participation in the trial. • Planning the requirements for clinical trial material, ordering clinical trial material (head office or local vendors), setting up and monitoring the systems whereby the Clinical Research Assistant can ship CT material to the investigator, maintaining procedures to account for the CT material, checking the expiration of CT material and requesting extensions if necessary• Maintains study tracking, in accordance with the demands of the study.• Monitors and updates data in an Electronic Data Capture (EDC) system in a timely manner and in accordance with study specific guidelines.

Rajkot Area, India

Screening and Enrollment of study subjects.- Maintaining Site Master Files.- eCRF and paper CRF filling - Medidata (Rave)- Interactive Voice Respond System (IWRS) calling.- Study drug accountability.- Sample labeling and dispatching.- AE monitoring, reporting and follow up of study.- IEC/IRB correspondence including SAE submission, all essential documents.- Managing all trial activities including site initiation, Monitoring visit. - Updated study related trackers.- Communication with the Ethics Committee and Sponsor/CRO on behalf of Investigator.- Well versed with ICH-GCP guidelines & principles, Schedule Y, US FDA understanding and Ethics committee.- Assist in site monitoring visit.

M.Pharm, Pharmacology, First Division

Master in Pharmacy (Pharmacology)

B. Pharm, Pharmacy, First Division

Activities and Societies: Participated in the national Pharmacy Week organized by pharmacy department Qualified for GPAT in 2010.

Intermediate, Science(Bio), 1St Division