Akshay Jadhav Email & Phone Number

Mumbai, Maharashtra, India

• Responsible for all aspects of study projects with first-line contact with the Principle Investigator, the Clinical Research Associate’s and the Sponsors. Recruited and interviewed study participants and arranged patient visits.• Responsible for performing Site Initiation Visits (SIV’s), Site Monitoring Visits (SMV’s) & Closeout Visit (COV) according to plan and procedures.• Creating source documents & maintaining reports to ensure finances & objectives meet the protocol requirements.• Establishing and organizing Study Files, Regulatory Binders, Study Specific Documentation, Inform Consent Documents, Case Report Forms, Enrolment Logs, and Drug Accountability Logs and supported in filing and archiving Trial Documentation in ISF (Investigator Site File).• Proactive usage of EDC and other data source systems.• Screened maximum subjects for eligibility using protocol-specific Inclusion & Exclusion criteria and documented each potential participant's eligibility.• Ensuring regulatory compliance and SOP's. Performed sample collection and ordered supplies.• Arranging secure storage of study documents according to ICH-GCP guidelines.

Thane, Maharashtra, India

• Overseeing the smooth running of clinical trials.• Collecting and analyzing data obtained from research.• Monitoring research participants to ensure adherence to study rules.• Adhering to research regulatory standards and to ethical standards.• Maintaining detailed records of studies, including things such as drug dispensation.• Ensuring that the necessary supplies and equipment for a study are in stock and in working order.• Engaging with subjects and understanding their concerns.

Navi Mumbai, Maharashtra, India

• Developed and implemented operational strategies and processes to improve efficiency and effectiveness.• Establishes and maintained the operational policies and procedures.• Monitored and analyzed operational performance to identify areas of improvement.• Managed and motivated staff to ensure high performance and productivity.• Developed and managed budgets and financial plans.• Monitored and reviewed performances of the staff and took corrective actions when necessary.• Oversee daily management of entire office.• Ensure proper support of creative and sales departments..• Coordinate with human resources for recruiting and hiring needs and make the final decisions on hires in leadership or critical positions.• Monitored customer feedback and took appropriate actions.

Navi Mumbai, Maharashtra, India

• Developed and implemented business strategy and influence change through effective relationship management across a wide network of partners.• Ensured the service provider owns and provides timely reports on monthly performance.• Provided support and assistance to other team members.• Kept track on cost changes and provided justification to manager.• Worked with the sales teams and other departments to help them learn about changes to market trends and developments to procedures.

Navi Mumbai, Maharashtra, India

• Planned strategies for the organization, scheduled the seminars and workshops, took feedback from the people attending the same, identified new sales leads, created presentations and presented them to the customers, maintained fruitful relationships with existing customers, documented finances, attended conferences and meetings.• Trained and guided team members to maintain high productivity and performance metrics.• Assisted in recruiting, hiring, and training team members.

Post Graduate Diploma, Clinical Research Technology

• Relevant Coursework Completed: Clinical Pharmacology, Bioavailability & Bioequivalence Studies, Regulatory Affairs, Clinical Research.

Bachelor Of Technology - B. Tech, Biotechnology

• Relevant Coursework Completed: Genetics, Plant Biotechnology, Bioinformatics, Biotechnology Management and IPR. • Thesis: Callus.