Jackie Cruse
Business Dev and Project Management
Summary
High performing Global Project Lead with Program Management, Strategic Accounts, Client Relations, Start-up and Operations experience. Adept at planning, directing and maintaining continuous operations in various departments. Applying creative and analytical approach to operations for continuous process improvement and optimum results. Skilled at identifying or anticipating problems and providing solutions. Excels through leadership, training and empowering team to excel in performance. Thrives in fast-paced, creative, and diverse environment.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Project Manager II, BioPharma
Covance/Fortrea
Salt Lake City, UT
01.2022 - Current
- Responsible for project delivery with regards to agreed time, scope, cost & quality.
- Key client contact, establishing working relationships with client project teams resulting in client satisfaction, operational excellence.
- Lead core project teams & facilitate teams' ability to lead cross-functional teamwork among internal & external stakeholders.
- Point of escalation for project issues, internally & externally.
- Proactively identify risks & resolve conflicts as needed.
- Understand project delivery strategy, costing assumptions & budget.
- Monitor project scope, schedule & costs to ensure financial performance targets are met. Initiate & implement actions to proactively manage change control process internally & externally.
- Proactively lead quality control & risk assurance activities to ensure project deliverables meet regulatory, internal & client requirements.
- Create & manage variance to required project plans. Per SOPs, implement & monitor progress against project plans & revise as necessary. Ensure all staff allocated to assigned projects adhere to professional standards & SOPs, & provide feedback to Line Managers.
- Develop & maintain KPIs for client metrics & ensure scope is in contract.
Manager, Planning & PreProduction Operations
Catalent Pharma CSS
San Diego, CA
07.2021 - 01.2022
- Managed Project Lead Team (PM, Pre-Prod, Pre-Dist., Purchasing) to ensure project management, planning & flawless execution from award stage to completion for all projects at site.
- Established departmental SOP curriculum and lead training.
- Created & implemented reduced standard project timeline for site.
- Recruited, managed performance, set expectations, developed & coached direct reports & other team members.
- Ensured team supports & delivers supply forecasts & relevant info to drive S&OP and client management.
- Ensured KPI data & analysis are complete & communicated & identify process improvement initiatives and implemented.
- Supported client audits & lead audits for Project Lead department.
- Provided expertise in all operational activities & clinical trial SME at site.
- Ensured project financial elements including contract review, milestone management, budget tracking & oversight are adhered to & support invoice query resolution & aged debt activities.
Sr. Project Manager Integrated Projects
Catalent Pharma - Clinical Supply Services
San Diego, CA
04.2020 - 06.2021
- Integrated PM for cross business units (Oral Solution Delivery & Clinical Supply Services).
- Functional Integrated Team Lead for new Clinical Supply Services site in San Diego, CA overseeing all pillars of start-up including construction, budget, IT, systems applications, NSOP creation, hiring & onboarding, training, sales & marketing. - Ongoing through Nov. 2021
- Managed multiple manufacturing, packaging, storage & distribution projects at global scale.
- Created & managed timelines in Workfront & Smartsheets for internal & external stakeholders.
- Created Packaging Summaries, Packaging Requests, Distribution Summaries for packaging & distribution.
- Mentored peers at multiple sites & business units; onboard & manage direct reports.
- Managed contracts & change orders for revised scope.
- Accountable for billing & cross-referencing financial milestones, invoice reconciliation, aged debt.
- Used JDE for ERP, Clinicopia for label design, Global Scan Assembly
Project Manager
Catalent Pharma - Oral Solutions Delivery
San Diego, CA
05.2019 - 04.2020
- Managed CMO early phase projects to ensure projects are completed with integrity, accuracy & quality to meet deliverables & timelines for clients
- Client point of contact; liaise needs to internal team & leadership
- Created & adjusted project plans to account for dynamic targets, staffing changes & operational specifications
- Organized & led client meetings to collaborate, communicate & ensure project success.
- Submitted requests for proposal change orders and manage executed contracts.
- Updated billing, financial forecasting, & notify leadership of any potential financial risks or project delays
CLIENT SERVICES PROJECT MANAGER
Fisher Clinical Services/Thermo Fisher Scientific
Vacaville, CA
07.2016 - 05.2019
- Client Services PM position at remote site to integrate new systems with other teams to create cohesive business unit.
- Managed multiple GMP projects as single client interface for entire project life cycle from implementation, planning, through execution/delivery to project closure.
- Created client work instructions for customized services.
- Created proposals, revenue forecast, identify/prevent revenue leakage, & manage project scope.
- Created/approved invoices, & reconciled AR.
- Ensured all activities met timelines for internal/external clients.
- Collaborated with clients/vendors to finalize logistical requirements, clinical trial sample analysis, & drug product MFG campaigns.
- Created/revised departmental SOPS, Technical Agreements, Best Practices & Controlled Documents in MasterControl. Ensured all parties were trained on finalized documents.
- Captured deviations/CAPAs in TrackWise. Provided Event Notifications & follow-up to clients.
- Maintained client profiles, documentation, contracts, & storage requirements in SalesForce for global site communication.
- Programmed virtual inventory system for each project based on product & individual item platforms.
- Managed clinical trial material inventory, storage, & global distribution for global clinical trial sites.
- Clinical Research & International shipment SME.
Sr. CLINICAL RESEARCH COORDINATOR
Worldwide Clinical Trials
San Antonio, TX
02.2011 - 06.2016
- Managed Phase I/II clinical trials (generics, First to File, First in Human, Fed/Fasted/Sprinkled, Multiple Ascending Dose, DM II, CNS, hormonal contraceptives, narcotics, amphetamines, mass balance radio labeled) for various sponsors
- Cross-functional team leader conducted 5 trials/day with 6-80 participants at CRO based on protocols, GCP, regulatory requirements
- FDA clinical study reports for IND/IRB submission, recruitment material, informed consent, captured AE/SAE/pregnancy
- Created/reviewed sample harvesting logs, kitting/labels, clinic & project timelines, source documentation, EDC/CRF, clinical/processing lab packets & panels
- Analyzed ongoing production integrating screening, logistics, nutrition, technical, lab processing & clinical lab units. Implemented improvement in non-productive areas
- Resolved & hosted QC/QA/sponsor audits. Maintained TFM. Led weekly protocol meetings with cross-functional teams
- 24/7 Point of contact for all production issues
CLINICAL RESEARCH COORDINATOR
Urology Of VA/Sentara Medical Group
Norfolk, VA
09.2007 - 05.2009
- Managed Phase II/III metastatic/non-metastatic prostate & BCG refractory bladder cancer clinical trials conducting site pre-qualification/initiation visits, investigator meetings, recruitment, IRB submissions, regulatory, study visits, labs, drug admin./accountability, EDC/CRF, AE/SAE, audits
- Consistently interfaced with external partners including physician offices, insurance companies, hospitals
- Clinical experience: phlebotomy, injections (intramuscular, subcutaneous), VS, ECGs. Assisted with bladder installations, cystoscopies, urinary catheter insertion/removal
Education
Bachelor of Science - Clinical Research
Campbell University
Buies Creek, NC08.2006
Associate of Science -
Wayne Community College
Goldsboro, NC05.2003
Skills
- Leadership & Communication
- Strategic planning
- Client Services
- Innovation
- Attention to detail while overseeing entire perspective
Certification
- Inspire Award Customer Allegiance | December, October, January 2018
- Project Management 'Own It Challenge' Winner | April 2018
- Certified Clinical Research Professional | SoCRA 2008-Present
Additional Information
- Amazon | Fulfillment Associate 2018-2019
- Sales | Independent Insurance Agent 2009-2010
- Eastern Virginia Medical School | Research Coordinator 2007
- Site Management Organization | Research Coordinator 2006
Timeline
Project Manager II, BioPharma
Covance/Fortrea
01.2022 - Current
Manager, Planning & PreProduction Operations
Catalent Pharma CSS
07.2021 - 01.2022
Sr. Project Manager Integrated Projects
Catalent Pharma - Clinical Supply Services
04.2020 - 06.2021
Project Manager
Catalent Pharma - Oral Solutions Delivery
05.2019 - 04.2020
CLIENT SERVICES PROJECT MANAGER
Fisher Clinical Services/Thermo Fisher Scientific
07.2016 - 05.2019
Sr. CLINICAL RESEARCH COORDINATOR
Worldwide Clinical Trials
02.2011 - 06.2016
CLINICAL RESEARCH COORDINATOR
Urology Of VA/Sentara Medical Group
09.2007 - 05.2009
Bachelor of Science - Clinical Research
Campbell University
Associate of Science -
Wayne Community College
- Inspire Award Customer Allegiance | December, October, January 2018
- Project Management 'Own It Challenge' Winner | April 2018
- Certified Clinical Research Professional | SoCRA 2008-Present
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