Indrani Choudhury
Associate Site Activation Manager
Summary
Focused and results driven Study Start Up Manager & Maintenance Lead with prior experience as a Study Start Regulatory Specialist and Clinical Coordinator. Specializing in Phase II-III Clinical Trials with 13+ years experience. Seeking a challenging and responsible position to contribute knowledge, experience, and leadership in clinical research.
Overview
12
12
years of professional experience
4
4
Certifications
3
3
Languages
Work History
Associate Study Start Up Manager
IQVIA
11.2022 - Current
- Oversee the execution of Site Activation/ Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project milestones.
- Ensure collaboration including communication with regions and countries, to successfully deliver the agreed project scope.
- Identify regulatory complexity and challenges and offer creative and practical solutions to support the subsequent execution of site activation/implementation of Regulatory amendments POST SIV.
- Site Ready to Enroll Activities completion - Ensure vendor set up, training of site staff, equipment and IP supply is complete at sites, as per agreed timelines with client to ensure seamless site activation.
- Execute operational strategy/ expectations for maintenance of clinical study approvals, authorizations and review and negotiation of contracts/Budgets and essential documents.
- Work with Quality Management to ensure appropriate quality standards are maintained per ICH-GCP, local regulations and guidelines, for the duration of site activation (or Maintenance, as applicable).
- Achieved departmental goals by developing and executing strategic plans and performance metrics.
- Maximized performance by monitoring daily activities and mentoring team members.
- Communicated clearly with employees, suppliers and stakeholders to keep everyone on same page and working toward established business goals.
Regulatory and Start Up Specialist
IQVIA
06.2018 - 11.2022
- Assist the study start up teams with tasks required for site start up activities.
- Perform complex processes and tasks that eventually result in high quality deliverables that are completed according to service level agreements (SLAs) and within project milestones.
- Collaborate with the project lead/team members in creation/review of study documents. Act as point of contact for assigned deliverables for specific customers or projects.
- Lead new initiatives as per need and aid in adaption. Act as Subject Matter Expert (SME) of one or more workstreams/process.
- Preparation of internal guidance documents as per need.
Study Start Up Associate
ICON Clinical Research India Private Limited
11.2017 - 06.2018
- Plan, coordinate and drive all study start up activities from site selection list to IP release to achieve the agreed/contracted deliverables and metrics as agreed with Client.
- Responsible for all Study Start Up activities in accordance with agreed budgeted hours, manage and escalate any significant variation to study budgets.
- Accountable for the development, finalization and review of Master and Country Specific Subject Information Sheets/Informed Consent Forms (SIS/ICFs).
- Responsible for Study Start Up metrics and CTMS updates for assigned studies.
Regulatory and Start Up Specialist
Quintiles IMS
12.2013 - 08.2017
- Evaluated new business opportunities from a regulatory perspective, providing valuable insight into potential challenges or benefits.
- Stayed updated on changing regulations by attending industry conferences, maintaining professional expertise in the field.
- Advised executive management on the strategic direction of regulatory activities, incorporating both short-term and long-term goals for the company.
- Supported process development by offering guidance on applicable regulations throughout the process, ensuring adherence at every stage.
- Maintained detailed records of all regulatory activities, enabling quick access during inspections or audits.
- Collaborated with cross-functional teams to develop risk mitigation strategies, reducing potential non-compliance issues.
Clinical Research Coordinator
Apollo Hospitals
10.2011 - 12.2013
- Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
- Maintained compliance with regulatory guidelines through rigorous documentation and protocol adherence.
- Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
- Developed strong relationships with trial sponsors, ensuring ongoing collaboration and future project opportunities.
- Conducted thorough literature reviews supporting the development of innovative study designs and methodologies.
- Managed study budgets and resources to maximize return on investment while maintaining quality standards.
- Oversaw the management of investigational product supplies, ensuring appropriate storage conditions were maintained at all times for optimal efficacy during trials.
- Contributed to the successful completion of clinical trials by proactively resolving issues, mitigating risks, and meeting deadlines in a fast-paced environment.
Education
Diploma in Advanced Clinical Research Management - Clinical Research
AHERF
Chennai 04.2001 -
Master of Science - Applied Microbiology
Vellore Institute of Technology
Vellore 04.2001 -
Bachelor of Science - Biotechnology
CMR Institute Of Management Studies
Bengaluru 04.2001 -
Skills
Study start up to Maintenance of regulatory amendments till close out
undefinedCertification
Barnett Certified Clinical Research Professional
Timeline
Associate Study Start Up Manager
IQVIA
11.2022 - Current
Regulatory and Start Up Specialist
IQVIA
06.2018 - 11.2022
Study Start Up Associate
ICON Clinical Research India Private Limited
11.2017 - 06.2018
Regulatory and Start Up Specialist
Quintiles IMS
12.2013 - 08.2017
Clinical Research Coordinator
Apollo Hospitals
10.2011 - 12.2013
Diploma in Advanced Clinical Research Management - Clinical Research
AHERF
04.2001 -
Master of Science - Applied Microbiology
Vellore Institute of Technology
04.2001 -
Bachelor of Science - Biotechnology
CMR Institute Of Management Studies
04.2001 -
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