Shilpa Kulkarni

Shilpa Kulkarni Email id:-Mobile: - Professional profile Shilpa Kulkarni has more than 3 years’ professional experience in the Field of clinical research. In her current position as The Local Start-Up Specialist I (LSUS I) at Allucent, Shilpa is responsible in assisting and managing the Site Activation Milestones at a regional level, supporting the Site Activation project team by managing the start-up phase of several clinical trials in the UK. She is responsible for the preparation, compilation, submission, and maintenance of ethical and regulatory documentation required for clinical trials at local level, prepares, reviews and negotiates Clinical Trial Agreements and budgets with sites and compiles Green Light Packages for authorization of Investigational Product shipment to sites. Prior to this role, Shilpa served as a Global Study startup assistant, providing support and assistance in Study startup activities at Allucent. Shilpa holds a Bachelor’s degree in Homoeopathic Medicine and Surgery from the Bombay University and holds a Diploma in Clinical Research and Data Management. Education 2011 - 2012 Diploma in Clinical Research and Data Management Mitcon Institute of Biotechnology, India 1995 - 2000 Homoeopathic Medicine and Surgery (BHMS) University of Mumbai, India Skills Language English Full Professional proficiency Dutch Limited working Proficiency System proficiency CTMS, Veeva Vault MS office (Word, excel and PowerPoint) Outlook SharePoint, Box CTIS (For EU Submissions) IRAS (For UK) Page 1 of 4 Professional Experience Local Start-Up Specialist I, (UK/Ireland) Allucent, Schiphol, Netherlands Oct2024- Present Main role and Responsibilities:  Oversee CTMS to ensure study milestones are achieved on schedule  Support other Study Start-up team members with filing documents in the eTMF  Maintain comprehensive study documentation in eTMF and prepare for audits  Prepare, compile, submit and maintain regulatory & ethics committee documentation as required at local level  Facilitate interactions with regulatory authorities / ethics committee  Responsible for the preparation and compilation of answers for questions raised by the regulatory agencies/ ethics and submit the answers  Provide support to the Global Regulatory Manager (GRM) and/or Global Submission Specialist (GSS) as required  Review of regulatory documents for proper content before submission  Update project trackers with study information  Tailor the country SIS/ISF to meet country and/ or site specific requirements  Assist in the coordination, compilation and distribution of the site-specific Essential Document Package and sending to sites  Oversee initial collection and review of Essential Documents  Secure authorization for the shipment of Investigational Product to the site  Responsible for negotiation of budget and contract with the site with support from Global Site Contract Manager (GSCM). Global Study Start-Up Assistant Allucent (formerly known as CATO SMS), Schiphol, Netherlands Jan2023 - Sep2024 Main role and Responsibilities:  Streamline the Pre-population of global templates and forms (incl. study plans)  Pre-populate study level documents, forms and templates  Create meeting agenda, control and distribute meeting minutes during GSSU (study) meetings  Assist study teams in submission preparation  Assist in set-up of start-up tracking systems in CTMS  Assist in tracking relevant information and data in CTMS and/or other tracking tools  Assist in (CTMS) report generation and review  Check completeness of CTMS for all GSSU areas and follow-up with involved stakeholders where required.  Initiate and control signature process of study specific GSSU documents  Assist in document redaction for EU CTR submissions  Support Submissions to EU countries via EMA portal  Assist other GSSU team members with filing documents in (e)TMF for which they are document owner  Assist in transferring changes from Study Master site contracts into country- and/or site specific site contracts  Assist with Study specific translation of documents and perform QC of the translated materials Page 2 of 4 Study Start-Up Assistant CATO SMS, Schiphol, Netherlands Sep2021- Dec2022 Main role and Responsibilities: Start-Up activities for phases I-IV studies generally in the regions of Europe including:  Assist in the preparation of Clinical Trial Application documents for submission to competent authorities, ethics committees or any other authoritative body e.g., by creating documents, compiling packages, completing trackers, adapting templates, and following-up with authoritative bodies  Support Feasibilities, e.g. by supporting the creation of a potential site list, preparation of Confidentiality Agreements, outreach to sites, and collecting and tracking feasibility responses  Support Site Contracting, e,g. by tracking progress, sending reminders, performing quality checks, arranging signatures.  Support Study Start-Up by filing and tracking documents, as well as tracking of departmental metrics and KPI  Support in the preparation of study-related presentation materials  Support the expansion of study Start-Up intelligence  Supports Subject Matter Experts (SME) in the field of Study Start-Up activities to the evaluation/improvement of processes and procedures within the Quality Management System  Assure good communication and relationships with (future) clients, authoritative bodies and investigators  Contribute and take part in client evaluations, visits and bid defenses  Contribute to other areas of business as required  Contributed to studies focusing on the following indications and therapies: o Oncology o Pediatric Oncology o Immuno-oncology / hematology Medical Document Reviewer UWeUs, Remote May 2020 – Sep2021 Main role and Responsibilities:  Verify and review of Medical records of clients and summarizing those for legal purposes adhering to HIPAA policies and standard procedures  Ensure up-to-date documentation of records  Medical data extraction and analysis  Provide consolidated report and Summarization as per timeframes Student Supervisor HSV International School, Den Haag, Netherlands Nov 2018 – Sep 2020 Main role and Responsibilities:  Part-time Volunteer as a Students Supervisor  Ensure adherence to school policies regarding safety measures and document specific observations, if any Page 3 of 4 Clinical Research Coordinator Deenanath Mangeshkar Hospital & Research Center, India Jul 2013 – Nov 2016 Main role and Responsibilities:  Liaison with the Sponsor representatives, Principal Investigator and site staff from Site initiation to the close out phases of the clinical trials  Ensure compliance with the approved standard operating procedures (SOPs), protocol/amendment, and the applicable regulatory requirements, ICH-GCP guidelines  Coordination with the IRB/IEC for approval and handling queries  Management of regulatory submissions related correspondences, files documents preparation and project timelines  Assist in budget negotiation and developing recruitment strategies  Review and maintain all logs on site, viz, Drug Accountability log, Duty Delegation Log  Maintain track of drug storage, reconciliation and accountability  Facilitate, attend periodic meetings with sponsors, vendors, and maintain documentation of the minutes.  Build collaborative and effective working relationship with vendor ensuring client satisfaction  Manage tracking and maintenance of study specific site documents as per the protocol, filing and archiving of documents in SMF  Planning, organizing and managing the administrative activities related to the study  Provide support during Internal and external audits  Support the site staff in preparation for trial site audits, inspections and during monitoring visits. Provide training as and when required Pre-natal Coordinator and Counselor Deenanath Mangeshkar Hospital & Research Centre, India Jun 2010 – Jun 2013 Main role and Responsibilities:  Instrumental in setting up Pregnancy helpline and creating a database of frequently asked questions regarding pregnancy  Assist in data collection and analyzing for in-house retrospective study  Report Periodic update, study reports and resolving queries with IRB/IEC  Provide support in audits and laboratory accreditation as a team member of the Fetal Genetics department Claims Officer Deenanath Mangeshkar Hospital & Research Centre, India Jan 2005 – Mar 2008 Main role and Responsibilities:  Review of insurance claims submitted for approval. Medical Officer Deenanath Mangeshkar Hospital & Research Centre, India Jan 2002 – Nov 2005 Main role and Responsibilities:  Supervising patient management techniques.  Responsible for training of care support team and documentation of patient health records. 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