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
Phase I-III Clinical Trials
Site Ready to Enroll Activities
Regulatory and IRB submission
Contracts and Budgets Negotiation/Finalization
Essential Documentation / TMF management
Vendor Management
Regulatory Info tracking, reviewing and completion
Data collection & analyzation using CTMS, Infostart and Spotfire Tools
Expert presentation skills
Accomplished team leader
Employee training and mentorship
Certification
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 -