Dr. Pradipkumar Kharade
Clinical Research Domain
Pune
Summary
Self driven and results-oriented professional with 16+ years of experience in Clinical Research domain. Adept at managing complex projects, enhancing operational efficiency, and leading cross-functional teams to achieve strategic goals. Seeking a challenging position where I can leverage my expertise in Clinical Research domain to contribute organizational success and drive innovation.
Overview
19
19
years of professional experience
5
5
years of post-secondary education
Work History
Team Lead
Tata Consultancy Services
Pune
03.2014 - Current
- Experienced in strategic management and coordinating process-level assignments, with expertise in delivering technical support and synchronizing cross-functional activities.
- Skilled in documentation facilitation, training, and contributing to client standards.
- Managing projects within budget and time constraints, ensuring resource adequacy, and leading team development.
- Strong communicator focused on client satisfaction, adept at conflict resolution and adherence to deliverables.
- Monitors SLAs/KPIs, manages staff-related tasks, provides continuous feedback, and acts as gatekeeper for client-specific changes.
- Engages in proactive communication to align expectations and maintain strong representation.
- Occupied the position of Process Certifier, Trainer, Mentor, QCer, and Processor to strengthen team proficiency and compliance.
- Provide IT Back-up support for operational continuity and participate in the MedDRA forum to advance medical terminology standards.
Clinical Operations Specialist
Sciformix Technologies Pvt. Ltd
Pune
04.2011 - 05.2014
- Facilitated data entry and peer review support for the PV team while delivering comprehensive administrative and organizational assistance to regional specialists and managers within the Global Support Services group.
- Oversaw the collection, review, tracking, and archiving of clinical trial agreements, contracts, and grant-related documents.
- Played a key role in supporting the Global Team in Contracts & Grants, ensuring meticulous review and quality control of financial documents.
- Managed the global tracking and follow-up of contract requests, conducted analysis of contractual relationships including investigator grants, and assisted in the strategic planning and execution of grants and contracts.
- Provided specialized guidance to analysts and managers in the negotiation of CTAs with CROs globally and managed the lifecycle of contract amendments under their direction.
- Developed process trackers for operational enhancements, led training initiatives for new team members, and designed and implemented process-related activities.
- Engaged in regular client interactions and relevant teleconferences to ensure alignment and progress.
Clinical Research Coordinator
Ruby Hall Clinic
Pune
12.2009 - 04.2011
- Conducted subject screening and enrolment, facilitated patient consultations, and executed all laboratory procedures with precision.
- Accountable for the measurement of vital parameters and monitoring patient well-being.
- Managed the completion of source documentation and Case Report Forms (CRFs), alongside proficient database entry using ORACLE, INFORM, and ARGUS platforms.
- Performed comprehensive reviews of patient medical records and expertly documented adverse events, encompassing both serious and non-serious incidents, while spearheading SAE reporting.
- Engaged in collaborative discussions with medical advisors on medically significant events, and meticulously entered data into client-specific patient safety databases.
- Ensured adherence to SOPs and ICH-GCP standards and contributed insights toward the development of site-specific SOPs and brochures.
- Demonstrated exceptional leadership as the Lead Clinical Research Coordinator (CRC) for various trials, showcasing a commitment to excellence in clinical research management.
Jr. Medical Officer / Training Coordinator / ICU In Charge
Bombay Bio-research Centre
Mumbai
11.2008 - 12.2009
- Experienced clinical research professional specializing in site-level trial monitoring and quality control of study documentation for accurate data capture.
- Proficient in managing volunteer registration, screening, and informed consent processes while ensuring medical fitness evaluations.
- Skilled in handling emergencies, adverse events, and serious adverse events with prompt reporting to sponsors and ethics committees.
- Adept at ensuring facility readiness and collaborating on protocol development with principal investigators.
- Successfully cleared a US FDA audit and developed SOPs to align with company standards.
- Committed to training new employees and ICU teams in line with best practices.
Medical Officer
Niramaya Hospital
Pune
03.2007 - 11.2007
- Deliver comprehensive patient care through regular assessments and tailored treatment plans, ensuring patient comfort and well-being.
- Foster clear communication with patients and their families, addressing concerns and providing essential health information.
- Collaborate with senior doctors during consultations to refine diagnostic approaches and therapeutic strategies.
- Support general surgeries by maintaining high standards of safety and efficiency, contributing to successful outcomes and seamless patient recovery.
Medical Officer
Primary Health Centre
12.2006 - 03.2007
Medical Officer
SSVYC sub district Hospital
09.2006 - 12.2006
Education
Post Graduate Diploma - Clinical Trial Management
Bilcare Research Academy
01.2007 - 01.2008
Post Graduate Diploma - Emergency Medical Services
Ruby Hall Clinic
01.2007 - 01.2008
Bachelor of Ayurvedic Medicine and Surgery - undefined
Bharti Vidyapeeth College of Ayurveda
01.2002 - 01.2005
Skills
- Microsoft Office Suite
- Excel
- Word
- PowerPoint
- clinical data management systems
- INFORM
- Oracle
- ARGUS
- RDE
Extra Curricular Activities
Worked as Medical Officer for Commonwealth Youth Games 2008, Pune Worked as Medical Officer for Pune International Marathon 2007, Pune Actively participated in Cultural and Social events organized by Sciformix Technologies Pvt. Ltd.
Awards
- Special Reward from the Principal Investigator at Ruby Hall Clinic for patient recruitment.
- Special Client STAR Awards at Sciformix.
- STAR PERFORMER and PERFORMANCE RECOGNITION accolades at TCS.
Additional Qualifications
Core Knowledge Assessment (CKA) in GCP, Association of Clinical Research Professionals (ACRP), USA
Timeline
Team Lead
Tata Consultancy Services
03.2014 - Current
Clinical Operations Specialist
Sciformix Technologies Pvt. Ltd
04.2011 - 05.2014
Clinical Research Coordinator
Ruby Hall Clinic
12.2009 - 04.2011
Jr. Medical Officer / Training Coordinator / ICU In Charge
Bombay Bio-research Centre
11.2008 - 12.2009
Medical Officer
Niramaya Hospital
03.2007 - 11.2007
Post Graduate Diploma - Clinical Trial Management
Bilcare Research Academy
01.2007 - 01.2008
Post Graduate Diploma - Emergency Medical Services
Ruby Hall Clinic
01.2007 - 01.2008
Medical Officer
Primary Health Centre
12.2006 - 03.2007
Medical Officer
SSVYC sub district Hospital
09.2006 - 12.2006
Bachelor of Ayurvedic Medicine and Surgery - undefined
Bharti Vidyapeeth College of Ayurveda
01.2002 - 01.2005
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