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Clinical research Manager, project Management, data management

Location:
Pune, Maharashtra, India
Posted:
March 30, 2019

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Resume:

Madhura Joshi

***, ******** *******, **/*, Shivajinagar, Pune- 411005, Maharashtra, India

+91-988*******

ac8ycz@r.postjobfree.com

** ***** ** ******** ******** including 05 years of managerial experience. A team-focused personality with multi-tasking orientation, efficient communication skills and good learning curve. Enjoys challenges and remains dedicated towards goals/objectives of the organization.

Skills

Clinical Trial Design and Strategies

Regulatory requirements for generic & 505b2 approvals, mainly USFDA

Leadership

Phase I to IV experience- end to end study activities

Clinical Data management

Project Management

Clinical End-point studies

Experience (Key points are enlisted below)

2017 – UNTIL NOW

Research Scientist, Head- Clinical Endpoint and Manger- Clinical Data Manager/ Lupin Bioresearch Center, Pune

Lead all clinical endpoint studies

Identify new CROs for conduct of clinical studies

Identify vendors for software to handle data management activities

Lead data management team and perform training for them

Participated in preparing data management Standard Operating Procedures

Handled audit for data management activities and clinical end point studies and provided satisfactory responses to clear the observations

Successfully executed all assigned projects including one oncology study- performed all operational and project management activities for this study success and received USFDA approval for this product

Involved in four inhalation PK studies as Physician, device trainer, project management activities and also lead all data management activities for these studies

Worked with Medidata for data management activities

Lead training and development activities and review the presentations of entire clinical research staff and arrange it once in a month for all staff for knowledge share

Act as a network leader for Lupin’s Women Network group and involve in various activities

2014 – 2017

Research Scientist, Manager- Clinical Endpoint / Lupin Bioresearch Center, Pune

Complete project management, vendor management and clinical development responsibilities for all clinical endpoint studies.

Lead all the clinical endpoint studies, right from the inception to final deliverables.

Single point of contact, both internal and external, for all clinical endpoint studies.

Lupin contact for CROs/vendors on RFP, study feasibility, study conduct strategies, study initiation to completion and study finances.

Support internal teams, mainly R&D and Regulatory, from product pipeline development to regulatory submissions.

2011 – 2014

Associate Scientist, Associate Manager- Clinical Endpoint / Lupin Bioresearch Center, Pune

Preparation and review of protocol, ICF, CRF and other study plans for clinical endpoint studies

Project management for all in-house projects and also work with CROs project management teams to review and track the activities for all outsourced studies

Performed all bid defense activities for studies of derma, ophthalmic, oncology etc.

Perform site qualification, monitoring visits to Investigators site and CROs

Provided clinical inputs to statistician to calculate the sample size for all the proposed studies

Provided training to Investigator site as well as project management team on protocol and other study requirements

2008 – 2011

Research Associate, Clinical Endpoint / Lupin Bioresearch Center,

A key role in preparation of SOPs such as project feasibility assessment, vendor selection & qualification, site visits & monitoring etc.

Compiled and reviewed all the clinical study documents

Coordinated with different CROs (India, US, Europe etc.) for getting cost estimates for pipe line projects

Accessement of CROs by reviewing their capabilities and therapeutic experience to initiate the vendor identification and selection procedure

Literature, draft OGD review etc.for various pipeline projects to provide clinical inputs

Pune

2006 – 2008

Clinical Trial Coordinator / Bharathi Vidyapeeth Medical Hospital & Research Center, Pune

Worked as a coordinator for National and International pediatric clinical trials (especially vaccine trials) and also coordinated Institutional Ethics committee and scientific Advisory committee meetings at Bharati Vidyapeeth’s Medical Hospital

2001 – 2006

Private Medical Practice / Pune

Also worked in Gynecology and Obstetrics hospital for 2 years and assisted all the related activities

Education

2010-15

MBA (Masters in Business Administration) / Yashwantrao Chavan Open University, Nashik

2005-06

CRCDM (Post Graduate Certificate Course in Clinical Research and Clinical Data Management) / Pune University, Pune

2001

Medical Transcription / Indian Transcription Group, Pune

1994-2000

BAMS (Bachelor of Ayurvedic Medicine and Surgery) / Bharathi Vidyapeeth Ayurveda College, Pune

Therapeutic Indication/Areas worked

Obstetrics & Gynaecology

Dermatology

Respiratory

Musculo-skeletal disorders

Opthalmology

Oncology

Oto-rhinolaryngology

Sleep Disorders

Gastrointestinal

Ayurveda

Awards and Achievements

USFDA approval for oncology product with no observation, 2019

Presented on Clinical supply management topic in Cold chain Management workshop held by Parenteral Drug Association in Apr 2018

Act as a best inhalation device trainer for inhalation studies, 2016 - 2019

Presentation given in GCP training workshop in 2017 and 2018 conducted by Lupin Bioresearch Center

Lupin’s ESOP received in 2015

USFDA approval for 04 derma corticosteroid products with no observations, 2016

‘Bravo award’ for the passion of excellence, 2014

Conducted Lupin’s first sleep study on an innovative drug, 2013

Winner of ‘Change maker contest’, to recognize the contribution in work related activities, 2012

Best contribution award, Rifaximin clinical trial, 2011

Active member of Lupin Women Network’s team, 2011-until now

Active participation in ‘Joy of Giving’ activity, 2008- until now

Interests

Would like to work in product development area to provide clinical inputs and strategies to move ahead for study conduct and product approval.

To provide clinical inputs to the clinical study from its inception to completion.

To handle clinical operations, clinical data management and project management activities of clinical studies

Also, would like to support or play a crucial role in other activities like selecting CROs, involve in bid defense process.

To lead all clinical trial activities from initial phase to final stage

References

Available on request



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