Priyanka Barve

Line Management responsibilities:

• Lead and manage a global team of 16+ members across different time zones (Canada, Europe, India) to ensure they supported in conducting their study activities that met sponsor expectations, timely delivery, and quality outputs following the study budgets while adhering to SOPs and regulations.
• Drive process improvement initiatives to enhance efficiency, quality, and productivity; collaborate with cross-functional departments to amend processes for increased efficiency.
• Oversee departmental resource management, effectively managing current project resources, and forecasting future needs based on work volume in the pipeline.
• Review study tasks considering the phase of the study (Start-up/conduct/close-out) and timelines, determining necessary resource levels and projections to align with client needs, expectations, and contractual obligations.
• Set KPIs and perform quarterly performance evaluations, reviewing employee goals, discussing strengths, providing feedback, and supporting career development.
• Collaborate with cross-functional stakeholders to evaluate and implement new clinical systems (Veeva Vault/CTMS/Vendor Portals) to ensure client satisfaction with deliverables.
• Develop and mentor employees to ensure high-quality work performance and retention.
• Support internal stakeholders in creating and updating tools and SOPs.
• Develop and conduct training for employees on current and new processes; conduct departmental meetings and provide regular process updates and support.
• Monitor employee contribution margins and ensure consistent billability within expected limits; implement creative engagement strategies during low work periods and provide cross-functional support.
• Develop departmental goals, monitor progress, share updates with leadership, and analyze the impact on team efficiency.
• Regularly update and maintain Power BI dashboards to provide leadership with real-time data and project status.

TMF Quality Lead responsibilities:

• Overseeing the quality of TMF for current studies.
• Supporting the team of Project Coordinators and Project Assistants to ensure the TMF completeness is conducted routinely for their studies during the site activation, study conduct, and closeout phase.
• Collaborating with Clinical research associates, clinical operations lead, TMF leads and managers to strategize the enhancement of the TMF process to ensure documents are filed in TMF with great quality and maintaining the SLAs and following sponsor requirements.
• Supporting the organization in the implementation of Veeva TMF and conducting the training for the department on the same.
• Evaluating the quality of TMF by performing quarterly quality checks on studies to ensure the expected documents are filed in TMF following the required quality standards.
• Supporting the Project Coordinators and CRAs in resolving their queries regarding TMF documentation.
• Providing training to CRAs, Project Coordinators, and Project Assistants on good documentation practices as they are responsible for filing a major pool of documents in TMF.

• Led studies and served as the primary point of contact for the Trial Master File (TMF).
• Collaborated with study teams, sponsors, and other internal/external stakeholders, noting sponsor expectations, and managing TMF tools customization and TMF Plan preparation.
• Coordinated study TMF activities to ensure TMF Inspection Readiness.
• Attributed document types in TMF as per the DIA reference model following ICF GCP guidelines.
• Conducted routine TMF completeness checks and milestone reviews (Start-up/Conduct/Closeout) by monitoring site activities to ensure proper document filing at every milestone.
• Maintained TMF for ongoing studies according to SOPs and contractual obligations to sponsors.
• Prepared and facilitated TMF for internal and external audits.
• Conducted TMF closure activities to ensure successful submission to sponsors.
• Reviewing and Updating TMF Plans in collaboration with cross-functional stakeholders and referring to the Project Management Plans, Monitoring Plans, and Communication Plans.
• Collaborated with Project Managers, CRAs, and COLs regarding site activities, patient recruitment, and site visits to ensure the inclusion of expected documents in TMF.
• Conducted training for new team members on project-specific guidance and collaborated with leadership on resource management.
• Worked with Record Management associates and Clinical Research Associates to resolve issues and queries, providing timely feedback to leadership.
• Collaborated with Super Users in CRS Technology to enhance systems, tools, and processes.

• Create and update clinical trial profiles from different sources such as trial registry websites, leading medical journals, media releases or company websites.
• Managed team of over 10 Clinical Document Specialist & driven 8 projects simultaneously
• Create Content for Clinical Trials Insight Database.
• Understanding of Pharma / Medical / Clinical trials terminologies.
• Thoroughly reviewing published clinical studies, drug development programs and updates.
• Identify key data and accurately input information into predefined fields / tables.
• Create trial profiles giving details of each clinical study / drug development program including key dates, status, phase, design, location, patient segment, endpoints, subject. characteristics, treatments, and results as well as timeline of key trial events, etc.
• Consolidate information from multiple sources like studies published in leading medical journals, posted on trial registry websites, information from media releases, etc.
• Write accurate and concise summaries that captures key elements from published reports / updates.

Clinical Document Specialist l (Jan2015 - Mar2017)

Clinical Document Specialist ll (Apr2017 - Mar2019)

Associate Clinical Document Lead (Mar2019 - Oct2020)

• Led TMF study projects, liaising with Project Management, Business Development, Client Services, IT, and Implementation teams throughout the study lifecycle.
• Managed a team of 10+ Clinical Document Specialists, overseeing 8 projects simultaneously and serving as the sole point of contact. Mentoring and supporting the team to ensure the documents are processed maintaining the SLAs.
• Supervised team activities, conducted individual discussions, provided feedback to employees and shared quarterly progress reports with vertical heads.
• Sharing performance metrics including the quality and productivity data of the team members with vertical heads monthly.
• Conducted interviews and provided training for new hires on processes and project-specific protocols.
• Represented TMF group in Project kick-off meetings in association with cross-functional teams and sponsors and understood and captured sponsor requirements. Prepared and implemented TMF processing plans, ensuring compliance with sponsor requirements and specifications.
• Conducted detailed reviews of TMF Configuration Manuals (TMF Index Manual/DIA Reference Model) and TMF management plan to ensure high-quality document processing.
• Monitored the quality, completeness, and accuracy of TMF at Site, Study, and Country levels, ensuring inspection readiness. Performed periodic risk-based quality reviews, using TMF completeness reports to identify and address missing documents.
• Collaborated with TMF contributors at all levels to ensure timely uploading of essential documents.
• Supported TMF implementation, internal audits, and regulatory inspections, ensuring TMF readiness for archiving at study completion.
• Coordinated with global team members to ensure consistency in project execution. Ensured achievement of all project milestones from the TMF perspective.
• Conducted weekly/biweekly meetings with Project Managers and clients to discuss project status and shared daily team progress reports with leadership. Led project-specific training sessions and resolved team queries.
• Demonstrated exceptional attention to detail, time management skills, and efficiency in meeting timelines and business goals.
• Adhered to applicable standards, policies, and regulatory guidelines to promote a safe working environment.

• Clinical Records Management activities.
• Identification, naming, categorizing of all types of documents (Clinical/ Non-Clinical) as per DIA reference Model.
• Checking completeness of eTMF documents as per SOP's and submitting to Quality Analyst team for QC.
• Updating MIS report.
• Meeting SLA for productivity and quality.
• Processed over 100 documents per day to achieve daily target with desired quality and within timelines.
• Working experience in First Doc.