Kenneth Pulmones
Clinical Project Manager
San Diego,CA
Summary
Highly motivated project management professional with 7 years in the pharmaceutical industry. Excels in a fast-paced team environment leading project teams and managing multiple client accounts to meet client timelines and deliverables.
Overview
7
7
years of professional experience
Work History
Clinical Project Manager
PCI Services
San Diego, CA
11.2021 - 03.2022
- Accountable for overall project management for assigned projects while building high rapport with clients by providing them excellent customer service. Maintained 100% client retention.
- Acted as primary customer contact for clinical packaging and distribution activities for nineteen clients. Effectively managed multiple concurrent studies for every client with study proposals worth up to $2MM.
- Communicated milestones, identified critical path activities, and delegated internal and external responsibilities to ensure projects achieved all deliverables per customer requirements and agreed upon timelines.
- Lead weekly project team meetings and technical kick-off meetings for every client. Maintained organization by generating and distributing ongoing weekly meeting notes and agendas.
- Strategically planned and coordinated client productions and product release to meet first patient in dates. Ensured fulfillment on vendor sourced packaging, shipping and ancillary supplies.
- Provided clients guidance with packaging solutions in areas of design and specification management; collaborated with associate PM's, internal engineering team and external vendors.
- Communicated with customers and vendors to resolve missing or erroneous certificates and documentation related to receiving and QC release of bulk, packaging components, and shipping supplies.
- Reviewed and finalized appropriate packaging documentation including material specifications, label proofs, master-batch records and job approvals forms. Responded to and revised any client requested or quality assurance findings accordingly.
- Coached and mentored newly hired Clinical Project Managers and Associate Clinical Project Managers. Monitors and updates Associate PM with production needs for project.
- Collaborated with Business Development team with regards to new proposals and resupplies, by assessing clinical protocols, study specifications, contracts, and other documentation.
- Forecasted and managed project expenses in adherence with finalized proposal. Initiated change orders to amend any additional expenses or services to original proposal.
- Reconciled and reported monthly invoices and revenue monthly for all assigned clients. Ensured accurate customer invoicing against itemized sales order is completed for proper billing and revenue.
- Hosted, scheduled and managed customer on-site visits at PCI.
Associate Clinical Project Manager II
PCI Services
San Diego, CA
11.2020 - 11.2021
- Provided continuous support to Project Manager and team by being daily point contact for day-to-day internal problem solving and trouble-shooting.
- Assumed role of client advocate and acts as secondary client communication point for clinical packaging, storage, and distribution for assigned projects. Acted as back-up Project Manager contact for internal communications and trouble-shooting.
- Additionally assumed role of Project Manager and acted as primary contact for independently assigned clients.
- Coached and mentored newly hired associate clinical project managers.
- Lead weekly customer calls and Clinical Project Team meetings in absence of Project Manager and participated in Technical Kick-Off Meetings.
- Drafted and finalized project specific documentation including packaging/labeling protocols, label proofs, variable data forms, material specifications, sample shipment request forms, monthly finished goods inventories, logistic instructions, and returns shipment forms.
- Managed timing of internal process to ensure timely receipt and release of bulk, project packaging components, and shipping supplies.
- Coordinated with cross functional teams to ensure project milestones are achieved including label and component design, finalization of production documentation, QC release of materials and delivery and on-time shipments of order requests.
- Assisted in monthly packaging and distribution invoices processing.
- Resolved shipment delivery issues by working closely with distribution group, carriers, customer, and clinical sites
- Participated in internal meetings and reported to Project Management, Operations, and Quality Management teams.
Associate Principle Investigator
Intertek Pharmaceutical Services
San Diego, CA
07.2018 - 11.2020
- Monitored and facilitated progress of over 50 various client studies, including pre-clinical and clinical method development, validation, sample analysis and long-term stability studies.
- Communicated with study director and/or sponsor contact with regards to progress and timelines.
- Collaborated with Principal Investigator in th development/validation of pharmacokinetic, biomarkers, and antibody drug analysis immunoassays compliant with FDA guidelines, Sponsor protocols and Intertek SOPs.
- Responsible for lab scheduling, data processing (StatLIA/Watson/SoftMax Pro), data review, and creation of final bioanalytical reports.
- Responsible for creation of projects, study files and setup of LIMS.
- Ensured accurate record keeping with regards to Sponsor's samples, data and reports.
- Responded to QCC and QAU inspections and audit reports promptly, indicating corrective actions.
- Coordinated sample receipt, tracking and reconciliation. Ensured any discrepancies are documented and communicated to site or client.
- Communicated revenue status to client services for monthly budget tracking and forecasting.
- Trained and supervised the work of project analysts.
- Generated prep batches/run lists, worksheets, and plate setups in LIMS in accordance with bioanalytical procedures.
- Ensured accurate inventory of supplies for laboratory operations is maintained to execute assay schedule.
- Composed, revised and reviewed internal SOPs, memorandums, bioanalytical procedure and any deviations.
Project Analyst
Intertek Pharmaceutical Services
San Diego, CA
12.2015 - 07.2018
- Conducted sample analysis via ELISA, ECL and Cell based pharmacokinetic and immunogenicity assays for various client studies.
- Participated in the development process and validation of in-house immunoassays.
- Performed analysis in accordance to FDA regulations and applicable internal SOPs.
- Wrote and contributed to final written SOPs in the laboratory.
- Drafted final reports and organized raw data notebooks.
- Responsible for keeping accurate inventory of supplies for laboratory operations.
- Responsible for accurate record keeping with regards to sponsor's sample data and report.
- Responsible for communicating with client with regards to project.
Lab Assistant
Intertek Pharmaceutical Services
San Diego, CA
10.2015 - 12.2015
- Responsible for preparation and documentation of reagents for entire lab.
- Responsible for general lab safety with regard to employees and clients.
- Stocked lab supplies, washed glassware and disposed of biohazard waster.
- Maintained and calibrated laboratory equipment.
Student Researcher
University Of San Diego
San Diego, CA
01.2015 - 05.2015
- Headed vaccine development project: Analyzed peptide derived antibodies from chronic Helminthes disease causing fatty-acid/retinol binding protein.
- Conducted expression and proliferation of recombinant Hp-FAR-1 (mouse) and Na-FAR-1 (human) proteins in E. coli bacterial culture.
- Purified and characterized proteins via column chromatography, SDS=Page and Western-Blot. Analyzed binding affinities of therapeutic antibodies via ELISA, thermal shift assay, and QCM.
- Presented research Creative Collaborations Research Conference (2015)
Education
Bachelor of Science - Biochemistry
University of San Diego
San Diego, CA 08.2011 - 05.2015
Skills
Client and external communication
undefinedTimeline
Clinical Project Manager
PCI Services
11.2021 - 03.2022
Associate Clinical Project Manager II
PCI Services
11.2020 - 11.2021
Associate Principle Investigator
Intertek Pharmaceutical Services
07.2018 - 11.2020
Project Analyst
Intertek Pharmaceutical Services
12.2015 - 07.2018
Lab Assistant
Intertek Pharmaceutical Services
10.2015 - 12.2015
Student Researcher
University Of San Diego
01.2015 - 05.2015
Bachelor of Science - Biochemistry
University of San Diego
08.2011 - 05.2015
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