Summary
Overview
Work History
Education
Skills
Accomplishments
Therapeutic Areas
Citizenship
Work Authorization
Roles And Responsibilities
music, listening to podcast, painting
Timeline
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Mugdha Joshi

8 Aztec street, North Kellyville,Australia

Summary

Diverse and extensive experience in clinical trial services.

Working in collaboration with various stakeholders such as pharmaceutical companies, universities, CROs, biotech industries etc. in Asia Pacific, UK, Europe and the US regions.

Some of the key vendors to deal with are CROs, Investigator sites, Database management team and various laboratory partners for the delegated projects.

Rich End to end project management experience including the project budget and expenses for more than 10 years.

Broad experience in people management and hiring and retaining a cohesive project team in Australia.

Leading multiple teams of different levels of Project Managers over number of years. At any given time managed a team of minimum 5 to maximum 15 people with different number of years of experience.

Successfully mentored Clinical Trial Assistants, Project Coordinators, junior and senior levels of Project Managers.

Performance managed project teams to ensure delivery of KPIs.

Subject Matter Expert for various processes within Project Management at central reference laboratory.

Attended multiple audits and prepared project teams for audit readiness.

Worked with Kit Building/production team to manage the team and processes and to support the business in a peak busy period.

Reporting into Director of Clinical Operations. Part of Functional Leadership Team for more than 2 years.

Greatly involved in supporting management growing the business globally in UK, Europe and USA regions.

Supported partner laboratories based in UK and USA in setting up studies for their own region.

Forte: Team management, mentoring and developing individuals to achieve their goals and company’s business growth, Time management and organizational skills, multitasking, Strong Microsoft applications and database skills, Ability to work as part of a team and independently, good interpersonal skills, strong communication skills, self-motivated.

Well-versed in building positive relationships with customers and other stakeholders.

Strong requirements gathering, scope development and inventory coordination abilities. Skilled at overseeing complex, high-value technical projects with excellent planning competencies.

Overview

7
7
years of professional experience

Work History

Project Services Delivery Manager

Sonic Clinical Trials - Sydney
02.2023 - Current
  • Partnered with project team members to identify and quickly address problems.
  • Managing team of 12 highly skilled Project managers at various levels and Project coordinators.
  • Monitored and tracked project progress to support timely completion.
  • Update customers and senior leaders on progress and roadblocks.
  • Led hiring, on boarding and training of new hires to complete business requirements.
  • Established positive and effective communication among unit staff and organization leadership, reducing miscommunications, and missed deadlines.
  • Evaluated team member performance and productivity, provided feedback and implemented corrective actions.
  • Established and enforced project timelines and deadlines
  • Resolved staff conflicts and identified potential areas of improvement
  • Generated reports for project progress and performance
  • Brainstorm IT strategies to improve operational efficiency
  • Assumed senior management workloads in absence of Director clinical Operations to maintain operations continuity.

Operations Manager

Sonic Clinical Trials - Sydney
02.2021 - 02.2023
  • Supervised operations staff (in between 12 to 15) and kept employees compliant with company policies and procedures.
  • Developed procedures to improve operational quality and team efficiency.
  • Managed inventory and supply chain operations to achieve timely and accurate delivery of goods and services.
  • Led hiring, onboarding and training of new hires to fulfill business requirements.
  • Established positive and effective communication among unit staff and organization leadership, reducing miscommunications, and missed deadlines.
  • Developed and maintained relationships with external vendors and suppliers.

Operations Supervisor

Sonic Clinical Trials - Sydney
10.2018 - 09.2020
  • Evaluated team member performance and productivity, provided feedback and implemented corrective actions.
  • Motivated and trained employees to maximize team productivity.
  • Managed internal operational standards and productivity targets.
  • Enforced regulatory and company policy compliance to improve workplace and employee safety and readiness.
  • Encouraged and promoted ideas aligned to business needs and benefits.
  • Supervised and motivated 9 staff employees.

Project Manager (Global)

Sonic Clinical Trials - Sydney
12.2017 - 09.2018
  • Managed total 65 projects at one time, which included more than 60% of global trials
  • Countries supported Asia Pacific, EU, UK, USA, India
  • Coordinated with cross-functional teams to resolve project issues and mitigate risks.
  • Monitored project performance to identify areas of improvement.
  • Planned, designed, and scheduled phases for projects.
  • Provided detailed project status updates to stakeholders and executive management and internal divisions.
  • Met project deadlines without sacrificing quality, documentation
  • Achieved project deadlines by coordinating with internal and external stakeholders.

Associate Project Manager

Sonic Clinical Trials - Sydney
06.2017 - 11.2017
  • Study set-up and study definition in Clinical Trial Management system
  • At any given time had at least 30 projects to manage with various statuses such as study set-up, maintenance, close-out etc.
  • With best client services was able to get repeat business from clients in first few months
  • Drafting of specifications Documents, Request forms and generating of Laboratory Manuals
  • Managed Budgets and work with clients to ensure that trial activities are well within budget.
  • Identified and resolved risks to better manage project without disruption.
  • Kept track for study progress by maintaining Project File for project requirements and establish traceability.
  • Partnered with project team members to identify and quickly address problems.
  • Delivered high level of service to clients to both maintain and extend relationship for future business opportunities.
  • Developed and maintained project documentation for reliable records.
  • Supported senior managers and department leaders by completing projects and problem resolution under tight budgets and schedule demands.

Deputy Manager – Clinical Research

METROPOLIS HEALTHCARE Ltd. - Mumbai
Sep2015 - Aug2016
  • Conferred with customers each day to maintain current understanding of needs and preferences, resolve issues, and promote brand loyalty.
  • Enhanced supervisory and leadership abilities by working closely with Manager of Department.
  • Maintained, documented and presented progress reports to leaders.
  • Supervised and motivated 5 staff employees.
  • Introduced new methods, practices, and systems to reduce turnaround time.
  • Introduced efficiencies by reviewing processes and by removing repetitiveness

Project Executive

SRL Ltd. - Mumbai
Apr2014 - Aug2015
  • Facilitated communication between departments and project stakeholders.
  • Determined appropriate financial expenditures and implemented budgets.
  • Provided leadership to team of 3 conducting business visitations, strengthening partnerships and executing market research.
  • Collaborated with upper management to assess business needs and develop roadmaps.
  • Evaluated project performance and made proactive adjustments to maintain quality and schedule.
  • Built impactful relationships with clients and suppliers.

Sr. Clinical Research Coordinator

SRL Ltd. - Mumbai
Apr2010 - Mar2014
  • Supported Project executives to set-up and manage number of trials.
  • Supported around 15 trials at any point of time
  • Worked with investigator sites and sponsors to facilitate daily trial activities and comply with research protocols
  • Data reconciliation and regular data transfers
  • Data File Quality checks performed regularly
  • Sites set-up in centralised LIMS system
  • Worked flexible hours across night, weekend and holiday shifts.
  • Managed time efficiently in order to complete all tasks within deadlines
  • Paid attention to detail while completing assignments.
  • Used critical thinking to break down problems, evaluate solutions and make decisions.
  • Proved successful working within tight deadlines and fast-paced environment.
  • Demonstrated respect, friendliness and willingness to help wherever needed.
  • Organised and detail-oriented with strong work ethic

Clinical Research Coordinator

SRL Ltd. - Mumbai
Feb2008 - Mar2010
  • Supported 6-8 trials
  • Arranged Logistics for shipping specimen
  • Worked in kit building area to build and ship trial specific kits
  • Drafted collection instructions to support sites during patient visits
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols
  • Self-motivated, with strong sense of personal responsibility
  • Skilled at working independently and collaboratively in team environment
  • Proven ability to learn quickly and adapt to new situations
  • Worked well in team setting, providing support and guidance
  • Paid attention to detail while completing assignments
  • Identified issues, analyzed information and provided solutions to problems

Education

Advanced Diploma in Clinical Research - Clinical Research

CATALYST INDIA LTD.
India
07.2009

Master of Science - Bioinformatics

Sikkim-Manipal University
Pune
07.2006

Bachelor of Science - Chemistry And Biotechnology

Pune University
India
04.2004

Skills

  • Supervision and leadership
  • Relationship Building
  • People Management
  • Analytical and Critical Thinking
  • Decision-Making
  • Conflict Resolution
  • Multitasking Abilities
  • Interpersonal Communication
  • Attention to Detail
  • Calm Under Pressure

Accomplishments

  • Successfully maintained a low attrition rate within Project Management Team by providing support and mentorship to various levels of Project Managers
  • Nominated with STAR of a company award
  • Repeat business from various clients, sponsors due to the strong relationship basis the trust and transparency
  • 3600 review completed and received Green band in all key areas

Therapeutic Areas

  • Diabetes/Hypertension
  • Microbiology (Fungal diseases, Culture & Identification)
  • Microbiology (In Vitro trials)
  • Bipolar Depression (Schizophrenia)
  • Dermatology
  • Hepatitis
  • Ophthalmology
  • Vaccine studies
  • Oncology
  • Asthma
  • Marketing tie-ups
  • Post Marketing Surveillance
  • Sample storage and shipment to various different laboratories

Citizenship

Australia

Work Authorization

No restrictions to work anywhere across the country.

Roles And Responsibilities

Provide effective management of Project Management Teams of the SCT central laboratory operations and supported Kit building division., Responsible for leading and managing a team of Project Managers, Associate Project Managers and Clinical Trials Assistants to support delivery of central laboratory services., Conduct formal performance reviews for direct reports and address any under-performance by an individual in an appropriate and effective manner., Ensures loading of database for readiness to initiate studies and build supplies for distribution to study sites on time., Ensure that all project deliverables are completed to client’s satisfaction, ensuring quality deliverables on time, within budget and in accordance with SOPs policies and guidelines., Point of escalation with sponsor clients in relation to study issues/feedback and assistance with problem resolution., Developing and maintaining clear communication channels between SCT departments as well as partner laboratories and support services., Be available to various clients/sponsors for regular meetings or catch-ups., Functions as the senior leader for project management team., Generate, review and submit reports to senior leadership team to present the number of projects per team/per PM, status (set-up, active, close-out), phases, participating sites, number of stakeholders on a regular basis for better resource management, Review workload utilisation and specific projects with staff on a regular basis. One on one catch-ups with individual team members on a regular basis., Drive staff development and training initiatives., Review progress of projects and initiate appropriate actions to achieve target objectives., Ensures that all department Standard Operating Procedures are current and adequately defines the processes for all work practices., To develop and refine SOPs and procedures for the department and provide training and development to departmental employees., Identifies areas for process and efficiency improvement and implements solutions., Regular reporting to the senior leadership team., Working with Business Development Team to workshop operational feasibility., Working with Business Development team to review the studies in pipeline and basis the probability matrix pre-assigning the Project Managers basis their workload to achieve faster and promising start dates., Meeting with various internal departments on a regular basis for managing different workflows and to maintain regular communication and flow of information., Conducting regular departmental meetings on-site/off-site for regular team building activities, Recognizing key achievements by team members and identifying them for their efforts and hard work, To work with a team of passionate project managers with empathy, compassion, respect and integrity., To assist management and HR to maintain a good culture within the organization., Initiating a Contract internally, with other partner labs and with client for all local/global studies, Communicating between different vendors maintaining the confidentiality signed with the sponsor, Ensure the regular and timely responses to the clients., Verifying invoices for all the clients and issuing the same periodically., Reviewing a budget versus expenditure for a client and keeping client/BD informed., Working with Project teams to Monitor the progress of each ongoing project contracted in accordance with all pertinent SOP's., Addressing client queries and investigating any issue escalated by the client, Ensuring 100% compliance to all SOP's pertinent to the project management production phase of the study. Any deviations from SOP's to be recorded & a corrective action plan to be drafted & firmed up., Working with quality team to ensure any complaints raised internally or externally are addressed with transparency and honesty., Managing study modifications with project teams by reviewing team’s capacity and supporting them to work with any new feasibility requirements, Ensure that Sponsor time lines for a data lock are met 100%. Also ensuring a smooth project closeout with project related documents & correspondence QC & archived as per pertinent SOP's without any deviations, Ensuring that the data cleaning is done as per the sponsor’s timelines for data lock., Ensuring that all study related documents are maintained in the study file., Ensuring that the data is checked & QC is carried out prior to submission for Archival., Ensure 100% compliance of all pertinent SOP's for this process & record any deviations along with a preventive action plan., Assisting in Internal & External audit for Study Specific CRS audit process by ensuring all documentation within CRS operations is aligned towards the Audit agenda., Ensuring documentation is in line with the audit agenda & SOPs., Co-ordination with various departments to ensure a smooth & successful audit., Any deviations to be recorded & preventive action plan to be put in place., Working towards proactive troubleshooting than reactive troubleshooting, Coordinating with internal departments in resolving queries raised by sponsor on a real time basis, Addressing of critical issues & unanswered queries in liaison with the internal departments, Assisting team members in getting a correct solution for the queries raised by Sponsor/CRO/Sites

music, listening to podcast, painting

Love calm music, helps me meditate!

Love listening to life changing podcast, helps me being positive and string in any challenges

Love painting with my daughter, makes me feel happy looking at her smile. 

Timeline

Project Services Delivery Manager

Sonic Clinical Trials - Sydney
02.2023 - Current

Operations Manager

Sonic Clinical Trials - Sydney
02.2021 - 02.2023

Operations Supervisor

Sonic Clinical Trials - Sydney
10.2018 - 09.2020

Project Manager (Global)

Sonic Clinical Trials - Sydney
12.2017 - 09.2018

Associate Project Manager

Sonic Clinical Trials - Sydney
06.2017 - 11.2017

Deputy Manager – Clinical Research

METROPOLIS HEALTHCARE Ltd. - Mumbai
Sep2015 - Aug2016

Project Executive

SRL Ltd. - Mumbai
Apr2014 - Aug2015

Sr. Clinical Research Coordinator

SRL Ltd. - Mumbai
Apr2010 - Mar2014

Clinical Research Coordinator

SRL Ltd. - Mumbai
Feb2008 - Mar2010

Advanced Diploma in Clinical Research - Clinical Research

CATALYST INDIA LTD.

Master of Science - Bioinformatics

Sikkim-Manipal University

Bachelor of Science - Chemistry And Biotechnology

Pune University

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Mugdha Joshi