Preeti Narayan

• Quality oversight to clinical research team and to clients concerning the conduct of clinical trial activities in accordance with applicable procedural documents, regulatory requirements and guidelines to ensure the Quality by design model of working involved in:

o Study Start-up Phase – Clinical study document generation, CRO/partner selection process, feasibility and site selection, study plan generation.

o Conduct Phase – Risk management assessment, Site quality score card evaluation, quality trend matrix assessment, and CRO/partner oversight, audit/inspection readiness for site and organization level.

• Perform Quality review of all essential clinical study documents for in-house & outsourced CTs to ensure compliance to company SOPs and regulatory compliance.

· Perform on-site quality oversight visit to ensure sites and vendors to have study inspection ready.

· Supervise and/or Conduct internal system review to identify gaps and suggest corrective and preventive actions

· Perform trend analysis provide strategic support to senior management and project team to ensure department upgradation.

· Facilitate end-to-end Regulatory inspections and/or internal audits.

· Support the management in implementation of Corrective/Preventative Action process for audits (CAPA)

· Perform vendor assessment and qualification visit buid partnership for CT activities.

· Coordinate with department heads to assess and implement training requirements.

· Supervise development and revision of organizational level process documents including – Standard Operating Procedures, WIs etc.

· Provide training on Clinical Trial Quality-related topics, guidelines, SOPs and regulatory changes

· Line management support in mentoring and performance review for the reporting team members.

Regulatory Role:

· Lead on local and global clinical trial registry (CTRI, ClinicaTrial.gov etc) management.

· New drug application and subsequent regulatory submission using SUGAM platform for all phases of CT

Additional Responsibility:

· Operations lead and project management responsibilities for in-house PK-PD Insulin clamp study; including attending NDAC meeting at DCGI office.

· Operations lead and project management responsibilities for ADME (early phase) NEC molecule.

Accomplishments:

• Streamlined the GCD processes and procedural documents to align with global & local business standards & regulations.
• Conducted Quality oversight visit for Wockhardt antibiotic CT and achieved successful closure of regulatory inspection leading to faster drug approval.
• Instrumental in supporting department shift from manual functioning to digital project management tools

• Provided regional input to new/revised Procedural Documents (PDs) and training materials.
• Served as process improvement consultant and liaison between BMS HQ and assigned region.
• Conducted internal and external audits/inspections which include system audits, process audits, site audits, vendor audits.
• Supported the training and implementation of PDs at regional level.
• Provided advice and guidance to staff on interpretation and implementation of GCP and PDs and associated documents
• Ensured Quality Systems and Best Practices are employed in assigned region and within the Regional Quality Team.
• Collaborated with Regional Clinical Operations (RCO) and Outsourcing Management to implement and coordinate quality oversight activities for vendors to supervise outsourced studies.
• Assessed processes and worked with manager to identify potential weakness in GDMA activities; proactively recommended improvements and provided solutions to stakeholders
• Collaborated with stakeholders e.g., global regulatory / global auditing, Country Medical Directors of legislation/regulation that may impact the business

• Collaborated with BMS alliance partners for timely supervision of out- sourced local and global studies
• Assisted in training and mentoring of team members i.e. CRA and CTAs
• Actively participated in decision making process related to site
• Identified sites and drive the study start up
• Monitored the progress of the study by close coordination between monitors and the sites
• Demonstrated overall understanding of the project goals
• Enabled proper site selection, achieving FPFV and country recruitment targets as per timelines
• Ensured database lock is achieved with the given timeframe
• Successfully collaborated with key stakeholders and they are medical monitors, protocol manager, site monitors, medical team and global regulatory group
• Resolved site queries
• Performed data management activities
• Proficiency in using ESF, IMPACT and TAO – company systems for PMF and documentation
• Performed site management activities, ensures that protocol execution and study documentation are in compliance with study timelines, ICH-GCP guideline, BMS SOPs and local regulatory guidelines or regulations

Accomplishments:

• Was instrumental in selecting and finalizing local vendor to support large global cardiovascular clinical trial study.

• Managed Clinical Trials are in compliance with corporate SOPs, and GCP and Local Regulations
• Established strong professional relationships with investigators
• Contributed to the Clinical Operations Business for the assigned Therapeutic Areas
• Worked towards ensuring optimal delivery on Patient commitments from Clinical Operations, India
• Ensured Program and Study Deliverables are on time
• Identified and Disseminated Best Practices and Standardization across Clinical Operations, India
• Ensured that all Protocols in the assigned Therapeutic Areas meet DCGI / DGFT Regulatory Requirements
• Actively Mentored assigned Mentees and flagged the required Training Needs
• Conducted regular Co-Monitoring Visits and reviewed Junior Peers’ Monitoring Visit Reports
• Assisted Line Manager for Audit Preparations
• Ensured Maintenance of Optimal Quality Standards at site level
• Ensured appropriate Filing and Documentation
• Assisted Line Manager with Dissemination of Patient Recruitment Plans

• Studied start up activities and co-ordination through clinical trial assistants
• Investigator’s grant calculations, calculation of per patient study grants for individual sites for the conduct of the study
• Site Selection
• Studied Site Initiation and monitoring
• Study Termination.
• Prepared study documents.
• Performed administrative duties including attendance at clinical monitoring staff meetings, project team meetings, and clinical training sessions.
• Identified and recorded quality problems.
• Coordinated between central and local laboratory.
• Coordination among the Investigators, study team members
• Performed other study related tasks as assigned by the project Manager.
• Assisted in Preparing the Work Break done structure, Study Proposal, Work Order, Master Service Agreement, Clinical trial Agreement, Non disclosure agreement, Project Management Plan and trial Document.
• Manage SAEs and liaise with safety departments to resolve SAE reporting issues.
• Prepared and made presentations at Investigator’s Meetings.
• Advice Institutions, which do not have ICH-GCP experience to set up their Ethics Committee to function as per ICH-GCP.
• Abided latest policies and procedures for the conduct of clinical trials.
• Prepared site monitoring visit report.
• Prepared of Study Reference Manual & Monitor’s Reference Manual.
• Reviewed & prepared the filing instructions prepared by the Clinical Trial Assistants (CTA) for the study.
• Prepared instructions for the central lab reporting.
• Supervised study handover procedures in case of change of staff.
• Prepared the site for the Audits