Nilam Parekh

Experience

• 

  Parekh Clinical Laboratory

  Oct 1997 - Jan 2001

  Assistant Medical Laboratory Technician
• 

  Pharma Medica Research Inc.

  Sept 2006 - Jan 2007

  Laboratory Assistant
• 

  BioPharma Services Inc.

  Jan 2007 - May 2008

  Clinical Research Technician
• 

  BAPS Swaminarayan Sanstha

  Jul 2007 - now

  Volunteer

  BAPS Walkathon CoordinatorCoordinated community events that promoted physical health, unity, and selfless service, in alignment with the values of Pramukh Swami Maharaj and Mahant Swami Maharaj. Worked with a team of volunteers to ensure successful execution, fostering community spirit and well-being.Volunteer, BAPS Community InitiativesActively contributed to BAPS events and service projects, assisting with organization and execution, while promoting the core values of humility, compassion, and teamwork. Show less

• 

  BioPharma Services Inc.

  Sept 2008 - now

  . Supervision of the Clinical Trial Documentation team including assisting theinterviewing and hiring of new staff, scheduling and setting up the timeline forstudy related activities.• Upload documents on Veeva for ETMF as per DIA reference model and resolve quality issues within the timeline. . Assign responsibilities related to the clinical documentations to members of theteam according to their workload.. Oversees and prepare ISF and/or TMF, as applicable, along with clinic staff, theongoing collection and filing of essential documents in the ISF and/or TMF/ ETMF on Veeva.. Coordinates, prepares, and submits appropriate documents to the ResearchEthics Board for review and approval (e.9., Protocol, investigators Brochures,informed Consent Forms, telephone screens, subject information sheets, andadvertisements). tracks the approval process and updates study team members on the approvalstatus of all clinical trials. Submits revised and additional materials to the Research Ethics Board (e.9.amendments, advertisements, safety/study status updates, and close outreports) as required. Reviews and files approval documentation from the Research Ethics Board in theISF and/or TMF/ETMF on Veeva and on the Study Specific Directory. Supervise and assist with the compilation, completion, and internal approvalprocess of Regulatory documentation (Qualified investigator Undertaking, FDA1572, financial disclosure, etc.) and provides completed Regulatorydocumentation to Sponsor/CRO for each study as well as filing in the ISF/TMF/ ETMF on Veeva.n Mentor, guide and assist associate member of the clinical documentation team,as needed.. Assist in the development of document templates, relevant SOPs and guidelines.. Assist with archiving duties: Ensure accurate and complete documentation of allclinic study source documents, case report forms (CRF) and/or forms accordingto company's SOP, GCP and other guidelines. Show less -Assign responsibilities related to the clinical documentations to junior members of the team according to their workload.-Prepare ISF and/or TMF, as applicable, along with clinic staff, the ongoing collection and filing of essential documents in the ISF and/or TMF/ETMF on Veeva.-Coordinates, prepares, and submits appropriate documents to the Research Ethics Board for review and approval (e.g., Protocol, Investigators Brochures, Informed Consent Forms, Telephone screens, subject information sheets, and advertisements).-Tracks the approval process and updates study team members on the approval status of all clinical trials.Submits revised and additional materials to the Research Ethics Board (e.g. amendments, advertisements, safety/study status updates, and close out reports) as required.-Reviews and files approval documentation from the Research Ethics Board in the ISF and/or TMF /ETMF on Veeva and on the Study Specific Directory.-Assist with the compilation, completion, and internal approval process of Regulatory documentation (Qualified Investigator Undertaking, FDA 1572, financial disclosure, etc.) and provides completed Regulatory documentation to Sponsor/CRO for each study as well as filing in the ISF and /or TMF/ ETMF on Veeva.-Expertise in use and application of the TMF Reference Model file structure as per sponsor request on Veeva Vault system.-Mentor, guide and assist junior member of the clinical documentation team, as needed Work closely with department management to improve the process of ISF/TMF and other regulatory documentations.-Compile study documents according to company's SOP, GCP and other guidelines. -Assist with archiving duties related to clinic documents including but not limited to CSR, TMF and ISF. Show less -Prepare ISF and/or TMF, as applicable, along with clinic staff, the ongoing collection and filing of essential documents in the ISF and/or TMF.-Tracks the approval process and updates study team members on the approval status of all clinical trials-Submits revised and additional materials to the Research Ethics Board (e.g. amendments, advertisements, safety/study status updates, and close out reports) as required.-Reviews and files approval documentation from the Research Ethics Board in the ISF and/or TMF and on the Study Specific Directory.-Assist with the compilation, completion, and internal approval process of Regulatory documentation (Qualified Investigator Undertaking, FDA 1572, financial disclosure, etc.) and provides completed Regulatory documentation to Sponsor/CRO for each study as well as filing in the ISF/TMF-Compile study documents according to company's SOP, GCP and other guidelines Perform other duties as required.-Assist with archiving duties related to clinic documents including but not limited to CSR, TMF, and ISFCoordinates, prepares and submits appropriate documents to the Research Ethics Board for review and approval (e.g. Protocol, Investigators Brochures, Informed Consent Forms, Telephone screens, subject information sheets, and advertisements). Show less -Review study files after completion and ensure that they are accurate and legible according to protocol, SOPs and regulations.-Ensure all prepared study source documents and/or forms are in accordance to protocols, SOPs and regulations.-Review all other study related documentation: medical screening files, pharmacy labels and files.-Work closely with CRCs to ensure studies are conducted properly with high quality and high efficiency.-Observe, on the random basis, clinical procedures during the conduct of studies, sample bundling and shipping process.-Provide reports of the reviewed data to relevant personnel/department Performs other tasks and projects as assigned. -Develop and utilize QC Checklist or other QC tools designed to document the QC reviewprocess.-Assist with training of new QC Data Reviewer Staff.-Participate in review of SOP's and Protocols.-Ensure the conduct of clinical trial according the applicable Good Clinical Practice (GCP) guidelines, applicable regulations, Protocol and Biopharma Services Inc SOP's at all times (copied from CRC's responsibility). Show less

  • Clinical Trial Documentation Manager

    Apr 2021 - now

  • Leader, Clinical Trial Documentation

    Aug 2020 - Apr 2021

  • Associate, Clinical Trial Documentation

    Jan 2020 - Aug 2020

  • Senior Quality control Data Reviewer

    Sept 2008 - Jan 2020