M N D Sai Mohan
Ahmedabad
Summary
Seasoned Clinical Project Manager with a proven track record at Lambda Therapeutic Research, adept in clinical trial management and stakeholder communication. Spearheaded over 11 studies, enhancing project efficiency and team performance. Excelled in mentoring, showcasing leadership and operational planning skills. Achieved significant improvements in trial timelines and data accuracy, aligning with strategic company objectives.
Overview
9
9
years of professional experience
Work History
Clinical Project Manager
Lambda Therapeutic Research
06.2023 - Current
- Aligned project priorities with organizational objectives, managing multiple tasks efficiently.
- Currently managing over 11 studies with different portfolios of medical imaging, including oncology, ophthalmology, and DXA.
- Drafting of documents that include the Independent Review Charter, Image Acquisition Guidelines, Operations, and Quality Control Manuals.
- Planned, designed, and scheduled phases for large projects.
- Identified plans and resources required to meet project goals and objectives.
- Drafted SOPs for the department workflows.
- Introduced new workflows in the department, and successfully created a team for that workflow.
- Managed the team, including the performance metrics, day-to-day activities.
- Part of the site selection committees and site initiation visits.
- New hire training plan and development.
- Monitored project performance to identify areas for improvement and make adjustments.
- Coordinated with cross-functional teams to resolve project issues, and mitigate risks.
- Developed comprehensive project plans with clear timelines, milestones, and budget requirements, ensuring timely delivery of high-quality results.
- Prepared detailed reports on project status for stakeholders, ensuring transparency and alignment with objectives.
- Collaborated closely with senior management to align project objectives with strategic company initiatives, ensuring that efforts contributed to overall business growth.
- Effectively managed scope creep by establishing clear boundaries on requested changes, while keeping projects aligned with original objectives and budgets.
- Negotiated contracts with vendors and suppliers, securing quality materials at competitive prices for efficient use of resources.
- Recruited and oversaw personnel to achieve performance and quality targets.
- Developed strong partnerships with key stakeholders to facilitate smooth handovers during project transitions.
- Mentored junior team members through skill development workshops and one-on-one coaching sessions to enhance their abilities in managing complex projects successfully.
Clinical Data Manager
Imaging Endpoints
01.2022 - 06.2023
- Provided training and mentorship to junior staff members, fostering professional growth and skills development.
- Enhanced data accuracy by implementing stringent quality control measures and periodic audits.
- Streamlined clinical trial processes for improved efficiency and reduced study timelines.
- Conducted ongoing assessments of data quality throughout the course of each trial, addressing any issues promptly and effectively.
- Developed comprehensive data dictionary for efficient and accurate data tracking.
- Built complex data analysis reports and provided timely feedback to stakeholders.
- Created data management plans and provided input on study designs.
- Participated in quality assurance reviews to verify accuracy and reliability of data.
- Worked with programming to coordinate Study Data Tabulation Model maps.
- Enforced strict data validation rules to maintain accuracy and completeness of clinical data.
- Assisted with database upgrades and migrations by performing user acceptance testing.
Lead Clinical Trail Imaging Specialist
Imaging Endpoints Pvt Ltd
Hyderabad
03.2019 - 01.2022
- Conducted thorough image analysis, ensuring accurate results, and contributing to key research findings.
- Conducted regular audits of existing processes to identify areas for improvement, driving continuous process optimization initiatives within the team.
- Trained new hires on the proper usage of imaging equipment and software, fostering a culture of excellence within the team.
- Presented research findings at conferences and industry events, showcasing the company's cutting-edge work in the field of medical imaging.
- Mentored junior researchers on their career development paths, while providing support on their individual projects.
- Provided expert guidance on best practices for imaging procedures, elevating team performance, and data accuracy.
- Maintained up-to-date knowledge of industry trends and advancements in imaging technologies.
Imaging Research Associate
Parexel India
01.2016 - 03.2019
- Conducted thorough image analysis, ensuring accurate results, and contributing to key research findings.
- Conducted regular audits of existing processes to identify areas for improvement, driving continuous process optimization initiatives within the team.
- Trained new hires on the proper usage of imaging equipment and software, fostering a culture of excellence within the team.
- Presented research findings at conferences and industry events, showcasing the company's cutting-edge work in the field of medical imaging.
- Mentored junior researchers on their career development paths, while providing support on their individual projects.
- Provided expert guidance on best practices for imaging procedures, elevating team performance, and data accuracy.
- Maintained up-to-date knowledge of industry trends and advancements in imaging technologies.
Education
PG DIPLOMA - Data Science
IIT-B
Bangalore06.2023
Master of Science - Biotechnology
GITAM University
Vishakhapatnam07.2015
Skills
- Project planning
- Stakeholder communication
- Clinical trial management
- IRB submissions
- Investigator relations
- Site monitoring
- GCP training
- Study design
- Clinical research
- Team management
- Clinical operations planning
Languages
Telugu
First Language
English
Advanced (C1)
C1
hind
Upper Intermediate (B2)
B2
Japanese
Beginner
A1
Affiliations
Cricket, Video games and Travelling
Accomplishments
- Managed care for over 18 Clinical Projects without escalations
- Started a new department activities within the scope of activities to generate more revenue
- created the workflow from beginning to end and create standard operating procedures.
- Product testing of the software with user defined requirements
- created User requirements and played active role in development of new software's
- Primary team member for an FDA and EMA audits and completed them without any observations.
Timeline
Clinical Project Manager
Lambda Therapeutic Research
06.2023 - Current
Clinical Data Manager
Imaging Endpoints
01.2022 - 06.2023
Lead Clinical Trail Imaging Specialist
Imaging Endpoints Pvt Ltd
03.2019 - 01.2022
Imaging Research Associate
Parexel India
01.2016 - 03.2019
PG DIPLOMA - Data Science
IIT-B
Master of Science - Biotechnology
GITAM University
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