Sahdeep Tripathi
Bengaluru
Summary
Seasoned Study Manager with a robust background at GSK India, showcasing expertise in project management and exceptional interpersonal skills. Excelled in vendor management, risk-based monitoring, and mentoring teams, driving projects to completion with efficiency. Proven track record in enhancing clinical trial oversight and stakeholder engagement, achieving over 90% on-time project delivery.
Overview
15
15
years of professional experience
Work History
Study Manager
GSK India
Bengaluru
09.2023 - Current
- 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 Plans, Risk Management plans, Communication Plans etc
- Local Operating Companies Liaison/Oversight –Including tracking of recruitment progress, data completeness and compliance, local budget oversight, protocol deviation oversight, supplies’ availability, regulatory approvals, and import license status
- Vendor management and CRO oversight- agreeing on study specific setup requirements, ensuring continued monitoring of agreed delegated activities
- Supporting SDL in quality and data oversight to ensure inspection/audit readiness, including oversight of eTMF completeness
- Setting up and maintaining clinical trial management system and tracking tools that ensure quality, consistency and integration of study data, following up on discrepancies if needed
- 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, recognize and communicating issues to continuity of supplies, proposing solutions as appropriate
- Coordination of study budget including support to contract management for vendor, managing expenses, tracking updates checking consistency between system 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, mentoring new resources
Associate Clinical Lead
IQVIA
Bengaluru
05.2022 - 09.2023
- Ensure clinical delivery of assigned projects in compliance with regulatory requirements, customer requirements (contract), and internal requirements
- Ensure the core clinical portion of Trial Master Files is up to date and maintained in accordance with SOP and TMF plan
- Implement QC activities, ensure compliance with quality measures and monitor required quality metrics
- Contribute to the development of the project risk mitigation plan and manage clinical risks throughout the project’s lifecycle
- Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issue
- Manage clinical aspects of Project Finances
- Understand the scope of clinical delivery and create plans to deliver
- Identify clinical stakeholder landscape for the project and manage both internal and external stakeholder through effective communication and resolution management
- Supervising, Leading and mentoring a team of Clinical Research Associates (CRAs) and clinical trial Assistants
- Resourcing and talent planning of the clinical team
- Manage the clinical/monitor team at project level to successfully deliver the project through the by providing establishment of high-quality operational plans and guidance and project related trainings
- Review and Approve site visit reports and the follow-up letters
- Conduct Regular team meeting and communicate appropriately to achieve objectives
- Support professional development by providing feedback to clinical team line managers on performance relative to project tasks
Associate Centralized Monitoring Lead
IQVIA
Bengaluru
11.2019 - 05.2022
- Acting clinical Lead: Initiate and run the closeout process across global sites, customize close out visit template, review closeout visit annotation for CoV, IP management in compliance with clinical operation plan (COP), approval of close out visit- either remote or onsite
- Manage budget to streamline the closeout process
- Provide oversight on clinical deliverable on assigned projects as per the protocol, SOPs, respective regulation/guidelines and project Clinical Operation Plan (COP) from Applications/ Analytics/ Therapeutics/ Quality
- Perform functional lead responsibilities for assigned project deliverable for specific customers or projects/specified
- Resource Management of Clinical Team (CRAs/CTAs/Centralized monitoring team)
- Budget forecasting and management for centralized monitoring team
- Attend Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested
- Contribute and/or oversee to the development and use of study management plans, specific tools and document templates and/or other study specific plans to evaluate the quality and integrity of the study; including complete and accurate documentation so that the project is audit ready
- Support project management team to develop monitoring strategy including monitoring triggers/thresholds
- Manage and monitor operational insight of the assigned project(s) and complete/oversee the study/site metrics trending (trend analysis of clinical aspects of the trial, share trends and agree on action plan, review, triage and action clinical study alerts, monitor clinical operation plan (COP) compliance etc)
- Contribute to developing the study specific analytics strategy and work on developing advanced analytics
- Provide Inputs to clinical study teams, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections
- Identify the value adds from the medical review & remote monitoring in the study and provide the inputs to relevant stakeholders
- Oversee the IP management for the assigned study to identify risk and proposed mitigation (including re-supply, re-labeling, Import/export licenses etc)
- Take up customer lead activities to provide oversight of un-blinded monitoring procedures on a study
- Act as mentor or coach for junior CMS staff
- Support the Centralized Monitoring Advisor/Centralized Monitoring Manager in periodic review of Centralized monitoring trainings and/or identify the training needs of the team and provide inputs as required
- Conduct periodic review of site level KRIs and historic site performance according to Central Monitoring Plan
- Early identification of site-level risk/issue(s) occurring during study conduct and responsible for identification of risk
- Monitor site performance and make recommendations for timely corrective actions (e.g
- Site Telephone Contact or Triggered Onsite Monitoring Visit)
- Review the effectiveness of the recommended actions and take appropriate additional actions if no effect is observed
- Review of the Study Central Monitoring Plan
- Act as point of contact for assigned deliverable for specific customer or projects
- Monitor operational triggers/Key Data Points/data trends and monitor their compliance check by performing regular Quality Check
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
- Establish and maintain effective project/ site level communications with relevant stakeholders
- Collaborating with peers and promoting cross functional synergies
- Project Oversight to site management activities on assigned projects and evaluate the quality and integrity of the study as per the protocol, SOPs respective regulation and guidelines
- Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles
Senior Remote Site Monitor
PPD (Pharmaceutical Product Development, India Private Ltd)
Bengaluru
04.2019 - 11.2019
- Liaise with monitors and investigative sites to resolve outstanding regulatory issues identified through ongoing regulatory reviews
- Oversee the execution and dissemination of study related information, including project tracking updates to clients, clinical study team and cross-departments
- Review invoices and accrual report on behalf of project manager
- Performed study site budget entries, running payment, and tracked the invoiced items for SVT creations
- Coordination of eTMF, Project file set up
- Upon direction of CTM/PM, finalize the table of content for all study files (Central, Internal, Country, and Investigator), develop and distribute
Remote Site Monitor, Level-II
PPD (Pharmaceutical Product Development, India Private Ltd)
Bengaluru
04.2017 - 03.2019
- Performed ongoing remote data review, assess for completeness of data and any observed protocol or GCP deviations/violations
- Performed event-triggered real-time data review and review of key risk, performance, and quality indicators (KRIs, KPIs, KQIs)
- Partners with Project Managers, Clinical Trial Managers, Lead CRA and Local country monitors
- Verified CRF Data and issue queries in CRF based on remote data review
- Tracked and assess trending of violations/deviations, enrollment status, and outstanding issues
- Ensured study systems are updated per agreed study conventions (e.g., Clinical Trial Management System – CTMS) to ensure adequate communication to project team and sponsor
- Liaised with CRA to prompt collection of documents, review of data points, findings from EDC and file reviews, etc
- Conducted remote investigations into site performance issues at the directives of CTM
- Represented PPD Remote site monitoring model in Sponsor’s Leadership meeting, USA
- Organized PD-PV reconciliation and shared with sponsor precisely throughout the year with no error in 2018, was appreciated by the client
- Maintained EDC data entry at real time and achieved 100 % pages completed for DMC in Feb 2019, which was highly appreciated by the project team
Remote Site Monitor, Level-I
PPD (Pharmaceutical Product Development, India Private Ltd)
Bengaluru
03.2015 - 03.2017
Clinical Research Coordinator, Level-II
Apollo Research & Innovations
New Delhi
04.2014 - 02.2015
- Worked as a Team Lead of Clinical Research Coordinators
- Coordinated study feasibility and liaised with Principal Investigators
- Liaised with CRO & Sponsor to coordinate all preparations of the Site Pre-selection activities, including site visit, establishing site / lab facilities & providing essential documents
- Worked as key point of contact with Institutional Ethics Committee for submissions and approvals of new projects
- Prepared and submitted study dossiers to regulatory authority (Drug Controller General of India)
- Documented & report Serious Adverse Event of clinical studies to Ethics Committee, Regulatory Authority and Sponsor
- Entered data and resolved queries in EDC as per the source documents
- Performed IXRS for subject visit registration and IP assignment
- Abstracted all required subject’s data from medical record for entry into CRF and eCRF
- Collaborated with the physician, reviewed subjects for changes in conditions, adverse events, concomitant medications, protocol compliance, & response to study drug
- Maintained Investigator Site Files, source documents & study logs
- Coordinated with lab personnel and shipping samples
- Entered data and maintained database in CTMS software
- Handled financial matters at site regarding payment received from Sponsors in the study & site expenses and Subject visit reimbursement
- Provided clinical trial training to fresher Clinical Research Coordinators
- Independently handled DCGI Inspections at site
- Prepared document for registration of Institutional Ethics Committee at Central Drugs Standard Control Organization (CDSCO)
Trainee- Clinical Research Coordinator
Indraprastha Apollo Hospitals
New Delhi
01.2010 - 12.2011
Clinical Research Coordinator
Indraprastha Apollo Hospitals
New Delhi
01.2011 - 11.2011
- Prepared agenda and minutes and submission dossiers for Ethics Committee meeting
- Assisted in completion of Sponsor Feasibilities, Site selection, Initiation, Audit/Monitoring & Final Study closeout
- Assisted Principal Investigator in screening & recruiting potential study subjects
- Developed study source documents, visit schedules and Pre-screening questionnaires
- Managed and organized patient visit schedule and ensured all the study/visit activities are accomplished
- Ensured that all the data are gathered & recorded in appropriate Source Documents and Case Report Forms (electronic & paper)
- Reviewed all forms and documents pertaining to a case for errors, missing information, legibility
- Resolved data queries (DCFs) and revert it back to CROs/Sponsors
Education
Master of Public Health -
Mahatma Gandhi University
Meghalaya01.2015
PG Diploma - Pharmaceutical Regulatory Affairs
Jamia Hamdard University
New Delhi01.2013
Post Graduate Certificate Course - Clinical Research
Apollo Hospital Educational and Research Foundation
New Delhi01.2010
Bachelor of Pharmacy -
RNS Institute of Pharmaceutical Science
Gwalior, Madhya Pradesh01.2008
Skills
- Project Management
- Event Trigger Real Time Data Review
- KRIs review
- Stakeholder Management
- Source Data Review
- ICF Process
- Data Analysis
- Risk Based Monitoring
- Resource management
- Interpersonal skills
- Budget forecasting
- IP Management
- JIRA
- Veeva Vault
- Vendor management
- Budget management
- eTMF maintenance
- Team leadership
- Process improvement
- Training and mentoring
- Monitoring plan development
- Study design
- Study documentation
- Clinical trial oversight
- Teamwork and collaboration
- Data governance
- Therapeutic area knowledge
- Project management
- Goal setting
- Clinical trial management
- Task prioritization
- Interpersonal communication
- Analytical thinking
- Microsoft Office Suite
- SAS
- Medidata Rave
- Inform
- CTMS
- IRT
- AI tools
Disclaimer
I hereby declare that the information provided in this CV are correct and can be verified against appropriate documents.
Phone
+91, 9654314403
Professional Development
- Public Health project: Nonalcoholic Fatty Liver Disease in School Children Aged 5-10 Years: Prevalence in overweight/obese and Normal Weight Children and its Association with Metabolic Syndrome, 2014-15
- On Medical writing, Apollo hospitals, New Delhi, 01/2012
- On Pharmacovigilance practice in India, Protocol writing in clinical trials, Clinical Trials in vulnerable populations, NIPER, Mohali, 11/2010
References
References available upon request.
Timeline
Study Manager
GSK India
09.2023 - Current
Associate Clinical Lead
IQVIA
05.2022 - 09.2023
Associate Centralized Monitoring Lead
IQVIA
11.2019 - 05.2022
Senior Remote Site Monitor
PPD (Pharmaceutical Product Development, India Private Ltd)
04.2019 - 11.2019
Remote Site Monitor, Level-II
PPD (Pharmaceutical Product Development, India Private Ltd)
04.2017 - 03.2019
Remote Site Monitor, Level-I
PPD (Pharmaceutical Product Development, India Private Ltd)
03.2015 - 03.2017
Clinical Research Coordinator, Level-II
Apollo Research & Innovations
04.2014 - 02.2015
Clinical Research Coordinator
Indraprastha Apollo Hospitals
01.2011 - 11.2011
Trainee- Clinical Research Coordinator
Indraprastha Apollo Hospitals
01.2010 - 12.2011
Master of Public Health -
Mahatma Gandhi University
PG Diploma - Pharmaceutical Regulatory Affairs
Jamia Hamdard University
Post Graduate Certificate Course - Clinical Research
Apollo Hospital Educational and Research Foundation
Bachelor of Pharmacy -
RNS Institute of Pharmaceutical Science
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