Bilkis Bhagwat

• Responsible for end-to-end operational study delivery, including development and review of study documents, completion and maintenance of internal systems/databases/tracking tools and project plans, vendor management, cooperation with Local Operating Companies (LOCs) and other internal functions.
• Executed trial management activities for in-house and outsourced studies across all phases and therapy areas, in accordance with standard operating procedures, clinical operational plans, regulatory requirements and Good Clinical Practice.
• Worked in close partnership with stakeholders.
• Delivery of study to plan, including managing the study team’s communication/meetings, tracking progress and the monitoring/assessment of risks to timeliness or quality of study
  delivery.
• Preparation and update of study documents and study plans, including study protocol, Monitoring Plans, Vendor Management Plans, Protocol Deviation Management Plan,
  Risk Management Plans, Communication Plans etc.
• Local Operating Companies liaison / oversight – including tracking of recruitment progress, data completeness and compliance, local budget oversight, protocol deviations oversight, supplies’ availability, regulatory approvals and import license status.
• Country Coordination calls (as applicable); Check-in meetings, study updates, support (questions, documentation), Status
  monitoring and reporting (start-up, enrolment, data cleaning, etc.) and coordination (agenda, minutes, action log, etc.) for the Central Study Team /Study Team Meeting, local study
  meetings, vendor kick-off meetings and investigator meetings.
• Vendor management & CRO oversight – agreeing on study-specific setup requirements, ensuring continued monitoring of agreed delegated activities.
• Led planning and executing of TMF management related activities of the clinical study, from study start-up till archiving, to ensure that the TMF is of high quality and updated in a timely manner to ensure inspection readiness.
• Worked on systems like CTMS, Clinical Prism, Study cockpit, Study Maestro, Planisware, Preclarus, vendor portals, RAMOS, Inform, Veeva Vault, SAP, eSBB, ARIBA, SPOTFIRE, LSAF, Covance cockpit, JIRA tool etc.
• Country Management-Handled APAC, EU & NA region
• Risk management – contribution to maintenance of a comprehensive risk management plan and risk tracking
• Clinical supplies and recruitment materials management – having oversight on study level supplies availability, recognizing, and communicating issues to continuity of supplies, proposing
  solutions as appropriate.
• Study budget management – including support to contract management for vendors, managing expenses, review Budget Actuals vs. Forecasts monitor expenses on regular basis and support to answer finance questions and any cost management plan maintenance, tracking updates, checking consistency between systems and agreements and escalating issues.
• Providing input to develop study specific processes and procedures, adhering to standardization and dissemination of best practices.
• Providing support to departmental initiatives and objectives, including for example support, training/mentoring as required.

• Initialised and maintained accurate clinical study plan and resource drivers.
• Worked with stakeholders to create plans with appropriate clinical study work packages
• Provided suggestions to improve efficiency of planning and scheduling of clinical studies to stakeholders, as applicable
• Contributed to scenario planning through developing alternative planning schedules for the study teams
• Knowledge on how to interpret data to draw conclusions so that others can make decisions and problem solve.
• Worked and gained command over MS Project and Planisware

• Clinical Operations document management
• Supported in start-up activities through maintaining relevant sponsor systems
• Drove eTMF archival
• Led automations related to archival and eTMF filing

• Carried out literature review to crate and support medical claims about neutraceuticals
• Reviewed and developed content for packaging and other promotional material for HCPs, consumers, media, retailers etc.
• Generated data for medical and regulatory submissions to Indian and International authorities.

Worked as an intern to gain experience in pathology.