Shalini Pal
Navi Mumbai
Summary
Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. Skilled at conducting site visits to check clinical operations and correct participant, documentation, or procedure issues.
Overview
10
10
years of professional experience
Work History
Site Activation Partner - Regulatory Start-up
ICON PLC
Mumbai
08.2025 - Current
- Collaborated with cross-functional teams to optimize clinical trial processes.
- Developed and implemented innovative solutions for operational challenges.
- Mentored junior staff in project management best practices and methodologies.
- Managed client relationships to ensure compliance with regulatory standards.
- Negotiated contracts between partners or vendors in order to obtain favorable terms for the company.
- Initiate and coordinate activities and essential documents management towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for sites initiation.
- Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572 for internal regulatory approval within the required timelines.
- Take the Lead, initiate and coordinates activities related to the compilation of high-quality IRB/EC package and ensure timely submission to approval (Central and or Local and in countries where applicable), and other committees as per country requirements
- Lead or assist with the preparation, handling, and distribution of clinical documentation and reports according to the scope of work and standard operating procedures.
- Ensure continuation of IRB/Ethic's and other committees activities Post SIV, and related submission, notifications, re-approvals etc.
- Responsible for timely filing of documents to Trial Master File and assisting with periodic quality review of study files for accuracy and completeness
- Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines
- Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections
Clinical Research Associate -II
ICON PLC
Mumbai
06.2023 - 07.2025
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans.
- Leveraged Clinical Research knowledge, expertise and problem-solving techniques to resolve investigative site issues.
Clinical Research Associate
Biorasi Clinical Research Services
Mumbai
08.2022 - 06.2023
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Conducted initiation and monitoring visits to verify study procedures, regulatory documents and data completion.
- Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Managed multiple projects simultaneously while maintaining a high level of attention to detail and meeting deadlines.
- Optimized patient retention rates by establishing rapport with participants and addressing their concerns promptly.
Clinical Research Associate
Macleods Pharmaceuticals Ltd.
Mumbai
04.2020 - 08.2022
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Liaised with clinical project leader to effectively resolve study-related issues.
- Provided clinicians with data to conduct clinical trials and determine methods to prevent, screen for, diagnose and treat disease.
- Oversaw project developments to provide quality deliverables while maintaining optimal efficiency.
- Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
- Adhered to procedures, practices, and regulatory requirements to maintain health, safety and environmental compliance.
- Reviewed data queries and listings and worked with study centres to resolve data discrepancies.
- Liaised with clinical investigator to identify, assess, and resolve site performance, quality and compliance issues.
- Created and maintained database and records filing system to document data on specimen collection, processing, and storage.
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Mentored team members by sharing suggestions and encouraging ideas to deliver successful studies.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
- Assisted in investigator selection and qualification process to provide capable investigators with adequate resources to properly conduct trials.
- Implemented electronic data capturing systems to adhere with clinical research guidelines.
- Followed drug storage procedures to comply with protocols and SOP requirements.
Clinical Trial Assistant
Macleods Pharmaceuticals Ltd.
Mumbai
10.2018 - 03.2020
- Oriented and trained new staff on proper procedures and policies.
- Conducted monthly and quarterly inventory of supplies using facility cost reporting records.
- Updated inventory, expiration and temperature logs to maintain current tracking documentation.
- Received clinical study documents from study team, reviewed for completion, accuracy & expiration, and filed the same in study file.
- Preparation of dossier for EC submission and sending required documents to sites.
- Prepared study files (TMF, SMF AND ISF) and sent IS to respective sites along with all required documents.
- Supported maintenance of the Trial Master File (TMF) & Site Master File (SMF) and assisted in quality control as appropriate.
- Supported Clinical trial manager and CRA to track and file documents and study metrics.
Senior Records Management Associate
IQVIA
Mumbai
03.2016 - 10.2018
- Function as team leader for records management projects.
- Ensure project deadlines, commitments, and goals are met by monitoring projects daily outputs.
- Coordinate retrieval of records requested by users and prepare closed studies to destination within agreed timeline.
- Train team members on records management tasks, policies, and procedures.
- Recommend changes or revisions to records retention schedules.
- Maintain accurate indices and databases to control inventory.
- Coordinate transfer, recall, and disposition of records to commercial records storage centres.
- Maintain records centre security to protect record integrity by ensuring compliance to SOPs.
- Collect data and assist in preparation of statistical reports for management on all phases of record centre operations.
- Design and administer records management systems and processes daily outputs.
- Access management - provide access of various clinical system such as EDC, CTMS, SharePoint, eTMF, etc.
- ETMF review - do comprehensive and inventory review of eTMF using annotated checklist.
Education
Post Graduate Diploma - Clinical Research, DM and PV
Ramniranjan Jhunjhunwala College
Mumbai, MaharashtraBachelor of Science - Chemistry
Ramniranjan Jhunjhunwala College
Mumbai, MaharashtraDiploma - Psychology : Counseling Psychology
EMO MATRIX
Skills
- Site Monitoring
- Clinical Documentation
- Site Management
- Project monitoring
- Report Writing
- Electronic Data Capture
- Drug Accountability
- Good Clinical Practices
- Records management
- Regulatory compliance
- Site coordination
- Team leadership
- Interpersonal skills
Hobbies and Interests
- Listening Music
- Reading Novels
- Travelling
- Cooking
Languages
- Hindi
- Marathi
- English, Bilingual or Proficient (C2)
- Hindi, Bilingual or Proficient (C2)
- Marathi, Bilingual or Proficient (C2)
Languages
English
Proficient
C2
Hindi
Proficient
C2
Marathi
Advanced
C1
Timeline
Site Activation Partner - Regulatory Start-up
ICON PLC
08.2025 - Current
Clinical Research Associate -II
ICON PLC
06.2023 - 07.2025
Clinical Research Associate
Biorasi Clinical Research Services
08.2022 - 06.2023
Clinical Research Associate
Macleods Pharmaceuticals Ltd.
04.2020 - 08.2022
Clinical Trial Assistant
Macleods Pharmaceuticals Ltd.
10.2018 - 03.2020
Senior Records Management Associate
IQVIA
03.2016 - 10.2018
Post Graduate Diploma - Clinical Research, DM and PV
Ramniranjan Jhunjhunwala College
Bachelor of Science - Chemistry
Ramniranjan Jhunjhunwala College
Diploma - Psychology : Counseling Psychology
EMO MATRIX