Kamlesh Bahekar
Nagpur
Summary
Experienced in successfully managing clinical trials from initiation to completion, ensuring strict adherence to protocols and regulatory standards. Utilizing strong project management skills, effectively coordinates cross-functional teams and maintains trial timelines, ensuring smooth operations throughout the process. Proven track record of efficient patient recruitment and meticulous data quality oversight consistently contributes to the achievement of successful trial outcomes.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Senior Clinical Trial Coordinator
QRed, Clinical Research Services
01.2022 - Current
- Streamlined cross-functional collaboration, enhancing trial efficiency and ensuring regulatory compliance while achieving recruitment targets and maintaining high data integrity
- Participated in the preparation and review of regulatory submissions, ensuring accurate representation of trial data and compliance with relevant guidelines.
- Developed comprehensive training materials for new team members, expediting their integration into ongoing projects without compromising quality standards.
- Established strong relationships with clinical site personnel, promoting open communication channels for resolving concerns or clarifying questions throughout the study duration.
- Enhanced patient enrollment by developing and implementing effective recruitment strategies for clinical trials.
- Worked collaboratively with external vendors to secure necessary resources and services for efficient trial operations.
Clinical Trial Coordinator
QRed, Clinical Research Services
09.2018 - 12.2021
- Coordinated Bioavailability/Bioequivalence (BA/BE) studies in the oncology, orthopedics, and hematology departments, ensuring regulatory compliance, managing subject recruitment and screening, and overseeing pharmacokinetic data collection while collaborating with interdisciplinary teams for analysis
- Documented and reported adverse events per protocol and regulatory guidelines, ensuring comprehensive safety data capture
- Demonstrated expertise in managing successful USFDA audits (Ovarian Cancer BA/BE study) and third-party audits (Asthma study with 80 subjects screened) with no major findings
- Effectively collaborated with sponsors, investigators, and stakeholders to drive study progress and ensure GCP/GVP compliance
- Oversaw the day-to-day management of the Investigator Trial Master File, including filing of essential documents, review, and approval processes
- Ensured the TMF was maintained to the highest level of quality, accuracy, and compliance with regulations (ICH GCP, FDA, etc.)
- Collaborated with cross-functional teams to ensure proper TMF setup, configuration, review, and archival
- Improved patient recruitment by developing targeted outreach strategies and collaborating with clinical research sites
- Streamlined data collection processes for increased efficiency in data entry and analysis
- Maintained compliance with study protocols, ensuring accurate documentation of all study-related activities
Territory Sales Manager
Med Manor Organics Pvt. Ltd.
03.2017 - 01.2018
- Built strong relationships with health care professionals to boost product adoption.
- Analyzed sales data to identify opportunities for improvement and implemented targeted action plans accordingly.
Education
Bachelor of Pharmacy -
Manoharbhai Patel College of Pharmacy/ RTMNU
Gondia, MH11.2016
Higher Secondary School Certificate -
Ravindra Vidyalaya & Junior College
Chopa, MH06.2012
Higher secondary school -
Ravindra Vidyalaya & Junior College
Chopa, MH05.2010
Skills
- Clinical Research Operations
- Trial Master File Management
- Case Processing & Safety Reporting
- Clinical trial management
- Skilled in MS Office
- Electronic Data Capture Systems
- Problem-Solving Mindset
- Adverse event reporting
Certification
- GCP Training Certificate, 02/01/24, AIIMS, Nagpur
- GCP Training Certificate, 04/01/22, Government Medical College and Hospital, Nagpur
Languages
English
Intermediate (B1)
Hindi
Upper intermediate (B2)
Marathi
Upper intermediate (B2)
References
Available upon request
Personal Information
- Date of Birth: 04/19/94 Nationality: Indian
- Gender: Male
- Nationality: Indian
- Address: Flat No201, Konarklaxmi Apartment, Beside Workout Gym, Dindayal Nagar, Nagpur-440022.
Timeline
Senior Clinical Trial Coordinator
QRed, Clinical Research Services
01.2022 - Current
Clinical Trial Coordinator
QRed, Clinical Research Services
09.2018 - 12.2021
Territory Sales Manager
Med Manor Organics Pvt. Ltd.
03.2017 - 01.2018
Higher Secondary School Certificate -
Ravindra Vidyalaya & Junior College
Higher secondary school -
Ravindra Vidyalaya & Junior College
- GCP Training Certificate, 02/01/24, AIIMS, Nagpur
- GCP Training Certificate, 04/01/22, Government Medical College and Hospital, Nagpur
Bachelor of Pharmacy -
Manoharbhai Patel College of Pharmacy/ RTMNU
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