Bhavana Narala
Monroe Township
Summary
Experienced Clinical Operations Lead with a proven track record in successfully managing phase 1-4 clinical trials for both adult and pediatric populations. Skilled in biospecimen management and working with laboratory information systems (LIMS) from various vendors. Recognizes the importance of assessing urgency, setting priorities, and effectively monitoring and tracking progress to ensure the successful delivery of projects, even when managing a large number of clinical trials. Possesses a highly independent yet team-oriented personality, fostering successful collaborations and relationships with core clinical and cross-functional teams, central labs, third-party analytical labs, and CROs.
Overview
9
9
years of professional experience
Work History
Clinical Operations Lead-Biomarker
Genentech
05.2022 - Current
- Collaborate with Biomarker Scientist and BOPL’s to design, operationalize and execute biomarker strategies
- Oversee all aspects of biomarker operational activities including but not limited to oversight of biomarker vendors, biomarker analysis timelines, compliance, budgets, maintenance of eTMF and RACT, mitigating risks and ensuring quality while adhering to ICH/GCP, SOPs and applicable regulatory requirements
- Offer biomarker expertise to clinical study teams during selection/identification of biomarker vendors, authoring protocols/ICFs, ensuring study/site feasibility, development of sample kits/sample collections and ensuring quality data delivery
- Accountable for developing biomarker management plans, operationalizing sample testing/data flow, defining vendor’s scope of work and executing deliverables as per study timelines
- Actively partner with global clinical operation leads, data management team, clinical scientists and other stakeholders to present biomarker strategies, ensure biomarker data delivery and communicate biomarker deliverables and timelines
Project Manager: Biospecimen Planning Lead
Bristol Myers Squibb
04.2021 - 04.2022
- Develop and implement asset & protocol level biospecimen strategies and biospecimen management plans for BMS sponsored phase 1-4 clinical trials along with externally acquired trials through Celgene and Receptos
- Support and oversee all planning/study start up activities required to manage the lifecycle of biospecimens from sample collection, processing, analysis, long term storage, data delivery and final sample disposition
- Assist clinical protocol study teams with study related queries, regulatory concerns, audits, and reviewing study documents such as study protocols, sample collection and processing materials, lab specs/lab manuals, DTS, etc
- Provide biospecimen planning and operational support to Translational Medicine, Clinical protocol study teams, Companion diagnostic teams and other stakeholders along with maintaining knowledge of sample collections, analysis, data returns, sample storage and movement
Associate Project Manager
Celgene/Bristol Myers Squibb
10.2019 - 04.2021
- Responsible for overseeing assigned clinical protocols by maintaining knowledge and status of all biomarker related activities
- Plan and design all biomarker related sample logistics, maintain regular metrics of biospecimen activities
- Utilize software tools to track biospecimens via RAVE iMedidata, eSample Biorepository, CovanceLablink, IQVIA Infosario, Brooks-Isidor Biostorage, etc
- Verify, review and document informed consent forms to ensure compliant utilization of biospecimens and long-term storage
- Initiate, develop and execute contracts with third party labs and long term storage sample-archival facilities
- Follow up and resolve discrepancies through communication with the study team, sites or CROs/vendors within specified time frames
- Assist with the consolidation of biospecimens at the close of the study
- Provide regular reports and summaries of biospecimens tracking activity including tracking of key study milestone dates, such as FPFV, CSR and biospecimen retention periods
Sample Management Technician
Bristol Myers Squibb via brooks biosciences
01.2016 - 06.2018
- Handled sample receipts, QC'ing, registering and storing of samples to facilitate daily sample operations in the Biorepository
- Managed and imported data for samples involved in BMS clinical trials using multiple LIMS systems to facilitate sample registration, sample tracking and processing
- Coordinated with stakeholders to ensure samples are received and shipped upon request while maintaining chain of custody and quality
- Identified discrepancies and worked closely with study teams, clinical sites and CROs to obtain issue resolution
- Assisted in building study specific translation tables in order to harmonize study specific terminology across all external BMS vendors
Education
Bachelor of Science - Biochemistry
Rutgers University
New Brunswick, NJ01-2014
Skills
- Proficient in EDCs, LIMS & databases(Rave, Lablink, Watson, Infosario, FMI and Cellcarta portals)
- Knowledgeable about the Biospecimen Lifecycle/Operations and Management
- Good understanding of Clinical Research and Management of Stakeholders, Vendors and Clinical sites
- Proficient in Establishing Collaborative Connections
- Experienced with OneNote and MS Office Applications
Timeline
Clinical Operations Lead-Biomarker
Genentech
05.2022 - Current
Project Manager: Biospecimen Planning Lead
Bristol Myers Squibb
04.2021 - 04.2022
Associate Project Manager
Celgene/Bristol Myers Squibb
10.2019 - 04.2021
Sample Management Technician
Bristol Myers Squibb via brooks biosciences
01.2016 - 06.2018
Bachelor of Science - Biochemistry
Rutgers University
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