Kalin Sofiev
Mullingar,DL
Summary
Experienced project management professional, manager & people leader with 12+ years experience of end-to-end clinical supply chain management to support clinical programs. Supporting from an operational planning level through to overall study planning, forecasting and supply chain management. Significant experience managing the overall supply chain function from study start up, maintenance and close out of a wide variety of clinical trials with varying complexities throughout. Highly motivated, analytical and results oriented individual, skilled at leading complex as well as multi-disciplinary projects and teams. Excellent leadership, interpersonal and communication skills with the ability to motivate and direct others in a supportive and cooperative cross-functional team environment with abundant global and international exposure.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Senior Clinical Supplies Specialist
GH Research Ltd.
02.2024 - Current
- In partnership with key stakeholders from Clinical Operations, Medical, CMC/Manufacturing, Quality and Regulatory oversee development of Clinical Supply Plan that documents study design, product requirements, and study assumptions e.g. enrolment, target countries, number of sites, etc. for each study included in Clinical Program.
- Oversee development of clinical demand forecast on study and program level and communicate this monthly to key stakeholders to ensure seamless coordination of demand and supply
- On ad hoc basis prepare clinical demand/supply scenarios using different combinations of inputs and assumptions to project both short-term and long-term supply availability
- Proactively identify issues with potential to impact clinical study and/or program and engage with key stakeholders to highlight risks and find solutions
- Design clinical packaging requirements
- Monitoring of enrolment, drop-out rates and actual supply needs. Ensure continuous re-assessment of project needs.
- Drive label creation and approvals process, including translations for all countries.
- Supporting vendor management process including RFP, and work orders with vendors.
- Support of regulatory filings including IND submission information, and audit from all health agencies.
- Monitor conformance to Clinical Supplies Inventory Management with Interactive Response Technology (IRT) standards where implemented.
- Design, implement and Oversee return and destruction of IMPs from sites.
Clinical Supplies Program Manager
ICON plc
03.2022 - 01.2024
- Coordinates procurement activities for investigational product, comparator, and other NIMP and /or ancillary supplies for high complexity studies
- Interprets relevant protocol information to develop packaging/labeling design for high complexity studies
- Provides support in managing clinical supply logistics at program level
- Acts autonomously in management of end-to-end clinical supply chain logistics for high complexity clinical studies
- Serves as subject matter expert (SME) in managing clinical supply activities
- Works closely with appropriate stakeholders to manage clinical supply forecasting and budget requirements for global studies
- Resolves clinical supply complaints and addressed supply replacement requests, as required
- Prepares required documentation and facilitates activities for import and export of clinical supplies
- Monitors and manages retest dating for assigned study supplies
- Manages drug supply delivery timelines with appropriate stakeholders
- Acts as primary point of contact in communication with all stakeholders to ensure adequate quantity and timely delivery of clinical supplies throughout duration of trial
- Leads discussions or work streams to develop process efficiencies
- Coordinates with Sponsor team to determine responsibilities in temperature excursion process and provides disposition of materials if contracted.
Sr. Project Manager Clinical Supplies - Digital/DCT
PPD
11.2021 - 03.2022
- Managed device and equipment provisioning for clinical supplies digital and decentralized trials.
Assisted in development of procedures, SOPs and guidelines related to clinical supplies digital and decentralized trials. - Implemented new shipping formс (MS Forms) specific needs of clinical supplies digital and decentralized trials.
- Worked closely with DIM (digital implementation managers) and provided monthly reports with operational data and root cause analysis related to depot shipments for NA (North America) region and ROW (rest of world) on clinical supplies digital and decentralized trials.
Global Clinical Supplies Manager
PPD
04.2019 - 11.2021
- Oversight for initial bidding on opportunities requiring GCS services by the sponsor including assumptions of direct and indirect costs for estimated budgets to be contracted
- Supervision of financial traceability and generation of purchase requisition forms aligned with vendor quotes
- Supervision and management of standalone trials which have not been assigned with GCS PM
- Providing training and coaching to new hired personnel within GCS and also coordinating tasks and completion of assignments
- Coordination, oversight and completion of administrative functions on assigned trials
- Provides administrative and technical support to Project team
- Coordinates responsibilities of project administration as applicable to client contracts.
Associate Manager Logistics Global Clinical Supplies
PPD
04.2017 - 04.2019
- Oversight for initial bidding on opportunities requiring GCS services by the sponsor including assumptions of direct and indirect costs for estimated budgets to be contracted
- Supervision of financial traceability and generation of purchase requisition forms aligned with vendor quotes
- Supervision and management of standalone trials which have not been assigned with GCS PM
- Providing training and coaching to new hired personnel within GCS and also coordinating tasks and completion of assignments
- Coordination, oversight and completion of administrative functions on assigned trials
- Provides administrative and technical support to Project team
- Coordinates responsibilities of project administration as applicable to client contracts.
Senior Project Assistant Global Clinical Supplies
PPD
11.2016 - 04.2017
- Also responsible for initial bidding for opportunities requiring GCS services by the sponsor including assumptions of direct and indirect costs for estimated budgets to be contracted
- Provides financial traceability and generates purchase requisition forms aligned with vendor quotes
- Responsible for management of standalone trials which have not been assigned with GCS PM
- Providing training and coaching to new hired personnel within GCS and also coordinating tasks and completion of assignments
- Coordination, oversight and completion of administrative functions on assigned trials
- Provides administrative and technical support to Project team
- Coordinates responsibilities of project administration as applicable to client contracts.
Project Assistant Global Clinical Supplies
PPD
01.2015 - 11.2016
- Handled administrative duties, filing, and errands.
- Worked with senior leadership to complete complex projects on time and under-budget.
- Completed multiple tasks simultaneously to optimize project completion.
- Performed work according to project schedules and established quality standards.
eSupport Technical Lead
Hewlett-Packard
02.2011 - 06.2012
- Tools retirement and account migration.
Courier/planner/dispatcher
FedEx Ground
04.2005 - 07.2010
- As courier I've maintained a good relationship with the customers and was able to answer questions about package shipping methods and varieties of delivery/pick-up options
- Responsible for picking up and delivering packages at homes and businesses on the delivery route operated
- Ensured that the scheduled pick-ups and deliveries planned for the day are completed as intended with a very good time management
- Main duties and responsibilities: Map route for best delivery
- Sort, Scan and deliver packages
- Use handheld computer to document deliveries
- High value of package handling
- Customer Service.
Education
Bachelor of Science - Business Management & Entrepreneurship
New Bulgarian University
Sofia, Bulgaria05.2024
Associate's degree - Associate in Arts
St. Petersburg College
St. Petersburg, Florida04.2004
Skills
- GMP, GCP, GDP
- IRT (IXRS) URS and setup
- TIBCO Dashboards
- Clarity PPM (Project & Portfolio mgmt)
- Oracle (ERP), SAP
- DTP/DFP/NIMP
- ETMF (VV, Phlex, Zen)
- ECOA/ePRO, eDiary
- Importer of Record (IOR)
- Packaging & Labeling
- Batch Processing
- Procurement/Invoice tracking and processing
- CNF/OOS budgets
- RFP/RFI proposals
- Salesforce (PSO)
- IOS/Android MDM
- DCT/Digital trials
- EDC (Inform, Rave, OCRDC)
- QA/QP/QC
- Account Management
- Standard Operating Procedure (SOP) creation
- Project Management
- Program Management
- Vendor management
Additional Information
Passionate about bringing new therapies to patients in dire
need. Spending my free time with my family, travelling, playing tennis, mt. biking and snowboarding.
Certification
Lean Six Sigma Green Belt
EDGE LEAD
ORACLE Clinical
Clario/Bioclinica IRT
Accomplishments
- Participated in Moderna Covid-19 vaccine development
- Implementation of Importer of Record (IOR) services
- Excellence CEO award
Languages
Bulgarian
Native or Bilingual
English
Native or Bilingual
Russian
Professional Working
Timeline
Senior Clinical Supplies Specialist
GH Research Ltd.
02.2024 - Current
Clinical Supplies Program Manager
ICON plc
03.2022 - 01.2024
Sr. Project Manager Clinical Supplies - Digital/DCT
PPD
11.2021 - 03.2022
Global Clinical Supplies Manager
PPD
04.2019 - 11.2021
Associate Manager Logistics Global Clinical Supplies
PPD
04.2017 - 04.2019
Senior Project Assistant Global Clinical Supplies
PPD
11.2016 - 04.2017
Project Assistant Global Clinical Supplies
PPD
01.2015 - 11.2016
eSupport Technical Lead
Hewlett-Packard
02.2011 - 06.2012
Courier/planner/dispatcher
FedEx Ground
04.2005 - 07.2010
Bachelor of Science - Business Management & Entrepreneurship
New Bulgarian University
Associate's degree - Associate in Arts
St. Petersburg College
Lean Six Sigma Green Belt
EDGE LEAD
ORACLE Clinical
Clario/Bioclinica IRT
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