Kalyan Deepthi Akula
@kalyandeepthiakula
Senior Clinical Project Manager with 18+ years driving compliant CNS & IVD trial execution.
United StatesWhat I'm looking for
I’m a Clinical Project Manager with 18+ years of Biotechnology experience, including 10 years leading CNS and IVD clinical research. I oversee complex CRO and reference testing lab partnerships and manage end-to-end trial execution from study startup to database lock.
I build and own core trial assets—clinical protocols, monitoring plans, adjudication charters, and essential study tools like CRFs and ICFs—while enforcing rigorous compliance with ICH-GCP and global regulatory standards. I also lead collaboration across Data Science, Biostatistics, and Data Management to keep studies on track and data integrity strong.
In my recent roles, I’ve managed budgets, timelines, vendor performance, and site staff compliance, mentoring CRAs through training, monitoring visits, and close-out activities. I modernize clinical operations with electronic TMF (eTMF) platforms and use high-level data reviews to identify trends, mitigate risks, and protect the integrity of trial results.
Experience
Work history, roles, and key accomplishments
Directed end-to-end clinical study execution, managing patient enrollment, data collection, monitoring, timelines, and budgets while ensuring ICH-GCP compliance. Led protocol and study document development, mentored CRAs, implemented eTMF platforms, and conducted data reviews to mitigate risks.
Served as lead monitor, mentoring junior monitors and coordinating with global sites, vendors, and sponsor stakeholders as primary point of contact. Developed monitoring plans and study documents, reviewed monitoring trip reports and study metrics, performed centralized data reviews, and supported interim analysis and database lock.
Senior Clinical Research Associate
HireGenics
Jan 2021 - Oct 2021 (9 months)
Coordinated clinical trial activities with CROs and sites to meet enrollment and data collection timelines, including review of protocol deviations and CAPAs. Contributed to protocol and eCRF design and other study documents, tracked clinical supplies and invoices, performed QC of central trial files, and supported SOP development and progress reporting.
Clinical Research Associate
Luminex Corporation
Jul 2016 - Apr 2018 (1 year 9 months)
Instructed investigator site staff and monitored external clinical sites to ensure GCP and ICH compliance. Developed study tools and forms, maintained trial master files, coordinated clinical supply shipments, and conducted site initiation, routine monitoring, and closeout visits.
Senior Reagent Quality Control Associate
Luminex Corporation
Dec 2012 - Jul 2016 (3 years 7 months)
Performed quality control testing on in-process and finished products, including method and instrument validations, and reviewed CoQs for completeness. Supported stability study sample planning and processing, executed electronic change control, and assisted with quality auditing and process improvement investigations.
Senior Research Associate
XBiotech
Dec 2008 - Dec 2012 (4 years)
Developed and optimized ELISA assays for specificity and quantification of therapeutic antibodies, and supported PK and immunogenicity assay development. Conducted protein characterization and QC testing (including SDS-PAGE, Western blot, SEC/CEX chromatography, and Octet RED binding kinetics) and performed microbiology/environmental monitoring with SOP creation and lab data integrity support.
Education
Degrees, certifications, and relevant coursework
University of New Haven
Cellular and Molecular Biology
2006 - 2008
Completed a Master's program in Cellular and Molecular Biology at the University of New Haven from 2006 to 2008.
Availability
Location
United StatesAuthorized to work in
Job categories
Skills
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