Devangini Dave Mahera
Project Manager
Ahmedabad
Summary
Highly energetic, enthusiastic, experienced clinical research professional specialized in the organization & management of clinical trials on medicinal products, aspiring to utilize acquired Skills in good organization.
Resourceful Project Manager with 9.5 years of expertise in organizing business operations, financial oversight and resource management to achieve smooth flow and project operations. Leads procurement of resources including equipment and supplies. Monitors projects by adhering to production schedule and budget, managing production team, identifying problems and providing targeted solutions. Knowledgeable in accounting principles, bookkeeping, budget, and financial management.
Overview
9
9
years of professional experience
3
3
Languages
Work History
Project Manager
Mavani Research Center
Ahmedabad, India
05.2023 - Current
- Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
- Planned, designed, and scheduled phases for large projects.
- Identified plans and resources required to meet project goals and objectives.
- Established effective communication among team members for enhanced collaboration and successful project completion.
- Coordinated with cross-functional teams to resolve project issues and mitigate risks.
- Managed risk assessments and implemented mitigation strategies to minimize potential issues during project execution.
- Developed comprehensive project plans with clear timelines, milestones, and budget requirements, ensuring timely delivery of high-quality results.
- Coordinated cross-functional teams and resolved conflicts, maintaining a positive work environment throughout the project lifecycle.
- Developed strong relationships with stakeholders through regular communication updates, fostering trust and confidence in the team''s ability to deliver results.
- Negotiated and managed third-party contracts related to project deliverables.
- Proved successful working within tight deadlines and a fast-paced environment.
- Developed comprehensive risk management plans, minimizing project delays and unexpected challenges.
- Recruited and oversaw personnel to achieve performance and quality targets.
Clinical Research Coordinator
Shalby Hospital, Ahmedabad
Ahmedabad
09.2021 - 04.2023
- Management of Clinical Trial
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Gathered, processed, and shipped lab specimens.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Maintained accurate and up-to-date case report forms and source documents for traceability.
- Prepared detailed informed consent documents to clearly communicate risks, benefits, expectations, rights and responsibilities related to participation in clinical trials.
- Coordinated with cross-functional teams to ensure timely completion of clinical trial milestones.
- Reduced data entry errors by implementing stringent quality control measures throughout the study lifecycle.
- Maintained compliance with protocols covering patient care and clinical trial operations.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
- Followed informed consent processes and maintained records.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Improved recruitment rates by developing and implementing effective patient outreach strategies.
- Coordinated with multiple departments to ensure compliance with regulatory standards, leading to successful trial audits.
- Negotiated contracts with vendors for trial supplies, ensuring cost-effective resource allocation.
- Developed comprehensive database for tracking patient information, improving efficiency in data management.
- Facilitated successful trial completion by closely monitoring study timelines and milestones, ensuring on-time delivery of results.
- Implemented electronic data capture system, significantly reducing paper use and increasing data retrieval efficiency.
- Improved trial visibility and public interest through effective community outreach and education initiatives.
- Led cross-functional team meetings to discuss trial progress and address any challenges, fostering collaborative work environment.
- Oversaw ethical conduct of clinical trials, ensuring all activities were in accordance with ethical guidelines.
- Collected, evaluated, and modeled collected data.
- Managed study budget effectively, minimizing unnecessary expenses and allocating funds wisely.
- Conducted site visits to monitor trial conduct and provide on-site support, ensuring high-quality data collection.
- Reviewed referral information and kept track of intakes from various referral sources.
- Complied with research protocols by providing ongoing quality control audits.
Manager
Arihant Orthopedic Hospital, Ahmedabad
Ahmedabad
10.2016 - 08.2021
- Management of Pharmacy
Education
Diploma - Advanced Clinical Research
DICE clinical Research
01-2021
Bsc - Biotech
Hemchandracharya North Gujarat University, Patan
Patan01-2018
H.S.C - undefined
Gujarat Board
01-2013
S.S.C - undefined
Gujarat Board
01-2011
Skills
Management of Clinical Trials
Assist in ICF Process
Schedule subject visits to ensure better subject compliance & subject retention
Ensure that all information required by CRF is present in hospital source documents
Performing study procedures/activities
Use IVR system for various applications during the study
Timely completion of CRFs with minimal errors
Assisting in resolution of queries / DCFs
Ensure compliance to the protocol, SOPs and applicable regulatory requirements
Responsible for Imps: receipt, storage, accountability and dispensing to subjects as per the protocol
Communicating with monitor, sponsor and IEC
Tracking study payments including reimbursement to subjects
Coordinate all site specific queries – Medical/SAE, administrative and others
Collect essential documents & forward to CRO / sponsor on regular basis
Update investigator site file on regular basis
Designing charts, logs to facilitate the conduct of the study
Coordinate with different departments such as pathology, radiology, nursing staff
Responsible for ensuring the coordinated patient follow up visits and CRA monitoring visits on a daily basis
Responsible for ensuring timely AE/SAE reporting to the necessary authorities along with completed document submission in coordination with the PI
Reporting SAEs and safety reports to IRB/IEC
Responsible for timely query resolution at the allocated site
Responsible for coordinating the site close out visits at the allocated site
Training of New Joining CRCs
Interests
Playing Garba, Listening Music, Traveling, Reading
CLINICAL TRIAL EXPOSURE
- I am trained on:
- NDCT Rules 2019
- Good Clinical Practice in accordance with ICH-E6 Guidelines E6 (R1) and E6 (R2)
- 21 CFR part 56 and 21 CFR part 50
- IEC operations
- ICMR guidelines for Biomedical Research on Human Subjects
Disclaimer
Declaration of Helsinki (Seoul, 2008) & WMA Declaration of Helsinki, Brazil, Oct 2013 I Devangini Dave, declare that all of the above information furnished by me is true to the best of my knowledge.
Reading, Dancing, Explore New things
Beyond my core qualifications, I bring a strong growth mindset and a genuine enthusiasm for continuous learning. I enjoy staying current with industry trends, exploring new tools, and working on personal projects that strengthen both my technical and problem-solving skills.
I am comfortable collaborating in diverse teams and communicating complex ideas clearly. Outside of work, I engage in activities that build creativity and discipline, such as reading, fitness, and skill-based hobbies that require focus and strategic thinking.
I am also committed to professionalism, adaptability, and delivering high-quality results. I take pride in being reliable, proactive, and open to feedback, always aiming to contribute positively to both team culture and organizational goals.
Timeline
Project Manager
Mavani Research Center
05.2023 - Current
Clinical Research Coordinator
Shalby Hospital, Ahmedabad
09.2021 - 04.2023
Manager
Arihant Orthopedic Hospital, Ahmedabad
10.2016 - 08.2021
Bsc - Biotech
Hemchandracharya North Gujarat University, Patan
H.S.C - undefined
Gujarat Board
S.S.C - undefined
Gujarat Board
Diploma - Advanced Clinical Research
DICE clinical Research