Summary
Overview
Work History
Education
Skills
Accomplishments
Languages
References
Timeline
Generic

Ishita Deb Mitra

DONNYBROOK,Victoria

Summary

Strategic and results-driven Senior Clinical Project Manager with over 15 years of experience in spearheading complex clinical trials across diverse therapeutic areas, including oncology, infectious diseases, and metabolic disorders. I am seeking a role to leverage my proven track record in delivering projects on time, within budget, and to the highest quality standards.

Throughout my career, I have demonstrated exceptional leadership, managing cross-functional teams across geographies and fostering a culture of collaboration and accountability. My expertise lies in risk management, strategic planning, and stakeholder engagement, ensuring project milestones are consistently met while maintaining compliance with regulatory standards.

With extensive experience managing phase I-IV clinical trials, both domestically and internationally, I possess a deep understanding of the complexities involved in clinical research. My strong communication and negotiation skills have enabled me to build and maintain strategic relationships with sponsors, vendors, and internal teams, driving project success.

I am passionate about translating project objectives into actionable plans and am committed to driving innovation and operational excellence in every project I undertake. My goal is to bring my leadership and project management expertise the role, contributing to the success of the organization and the advancement of impactful clinical research.

Overview

17
17
years of professional experience

Work History

Senior Project Manager

Southern Star Research
02.2024 - Current

Therapeutic Area : Oncology, General medicine

Senior Clinical Project Manager

Novotech CRO
02.2022 - 01.2024

Therapeutic Area : Oncology

Senior Clinical Project Manager

Greenlight Clinical
10.2021 - 02.2022

Therapeutic Area : Stem Cell Research

Clinical Project Manager

Syneos Health,(previously INC Research)
10.2016 - 10.2021

Therapeutic Area : Infectious Diseases, Metabolic Disorders, General Medicine

Project Specialist I & II

Syneos Health (previously INC Research)
11.2012 - 09.2016

Therapeutic Area : Infectious Diseases, Metabolic Disorders, General Medicine

Transcriptionist/Research Assistant

NZ Clinical Studies (previously Auckland Clinical Studies)
06.2011 - 10.2012

Therapeutic Area : Hepatitis B and Oncology, Dermatology

Clinical Research Coordinator

Fortis Flt. Lt. Rajan Dhall Hospital
05.2008 - 02.2010

Therapeutic Area: Cardiology

Lecturer, Biochemistry

Guru Nanak Institute of Dental Sciences and Research
08.2007 - 04.2008

Education

Master of Science: Medical Biochemistry -

Sikkim Manipal Institute of Medical Sciences
Sikkim, India
01.2006

Bachelor of Science: Microbiology -

PES College, Bangaluru University
Bengaluru, India
01.2003

Skills

  • Project Management: Ability to lead, plan, execute, monitor and control clinical trials from initiation to closeout within timelines, budget, and quality standards
  • Leadership: Proven track record of leading cross-functional teams, motivating and empowering team members, resolving conflicts, and driving collaboration and alignment
  • Communication: Ability to interact effectively with stakeholders at all levels, including sponsors, vendors, investigators, and regulatory authorities
  • Risk Management: Ability to identify, assess, and mitigate risks and issues, develop and implement risk management plans, and effectively manage changes
  • Quality Management: Strong understanding of quality management principles and processes, ability to ensure compliance with applicable regulations and guidelines, and drive continuous improvement
  • Financial Management: Ability to develop and manage project budgets, track and report project financials, and effectively manage resources
  • Relationship Management: Ability to build and maintain positive relationships with sponsors, vendors, investigators, and regulatory authorities, and effectively negotiate and resolve conflicts
  • Technical Knowledge: Solid understanding of clinical research regulations, guidelines, and standards, and experience with clinical trial management systems and other relevant software applications
  • Professionalism: Demonstrated ability to maintain a high level of professionalism, ethics, and integrity in all interactions and activities

Accomplishments

Received the Business Unit Excellence Award in 2016 for exceptional performance, including time and effort on projects, showing initiative, effective communication, and implementing processes to achieve results.

Languages

English
Bengali
Hindi

References

Available on request

Timeline

Senior Project Manager

Southern Star Research
02.2024 - Current

Senior Clinical Project Manager

Novotech CRO
02.2022 - 01.2024

Senior Clinical Project Manager

Greenlight Clinical
10.2021 - 02.2022

Clinical Project Manager

Syneos Health,(previously INC Research)
10.2016 - 10.2021

Project Specialist I & II

Syneos Health (previously INC Research)
11.2012 - 09.2016

Transcriptionist/Research Assistant

NZ Clinical Studies (previously Auckland Clinical Studies)
06.2011 - 10.2012

Clinical Research Coordinator

Fortis Flt. Lt. Rajan Dhall Hospital
05.2008 - 02.2010

Lecturer, Biochemistry

Guru Nanak Institute of Dental Sciences and Research
08.2007 - 04.2008

Master of Science: Medical Biochemistry -

Sikkim Manipal Institute of Medical Sciences

Bachelor of Science: Microbiology -

PES College, Bangaluru University
Ishita Deb Mitra