Summary
Overview
Work History
Education
Skills
Timeline
Generic

Cindy Bardascino

Merchantville,NJ

Summary

Clinical Research Professional with proven expertise in project management and cross-functional leadership. Achievements include successful mentoring of teams, conducting comprehensive risk assessments, and executing clinical trials with precision. Proficient in strategic planning and client relationship management, ensuring adherence to regulatory standards and delivery of high-quality results.

Overview

10
10
years of professional experience

Work History

Senior Clinical Team Lead

Rho, Inc.
10.2024 - 05.2025
  • Oversaw clinical operational activities from start-up to close-out for assigned projects.
  • Tracked and reviewed study KPI's and key deliverables.
  • Managed CRA teams, including site assignments, scheduling, and training for projects.
  • Collaborated with managers on hiring, developing, and assigning staff.
  • Mentored junior staff, including CRAs, In-house CRAs, SSU associates, CTLs I-II, and data management associates.
  • Monitored operational performance and efficiency, taking corrective actions as necessary.
  • Identified and secured essential resources for project success.
  • Proactively identified risks, implemented mitigation strategies, and resolved issues at all levels.
  • Led regular clinical team conferences to enhance communication and collaboration.
  • Served as primary clinical contact for sponsors, reporting on study progress and enrollment.

Project Manager

ICON
05.2023 - 10.2024
  • Provided leadership, mentored, planned, supported and operational delivery of assigned studies/T1D program through all phases of study management (start-up, conduct/maintenance, closure).
  • Served as an initial point of conduct for all clinical management, monitoring, vendor issues and other functional areas.
  • Supported review of approval trial budget(s), including ongoing vendor invoice reconciliation and scope of work review; worked functionally to support vendor contract changes and reviewed revised scope of work and budgets.
  • Drove the successful activation of trial sites according to time, quality/scope budget.
  • Contributor in quality assurance reviews.
  • Focused on internal and external customer service (Sponsors, study sites, vendors) related to site management and clinical monitoring activities to ensure timely and high-quality deliverables /scope through CTMS/eTMF / or tracking tools.
  • Planned and conducted initial and ongoing training for the study team on project-specific matters and enlists therapeutic assistance where applicable.
  • Responsible for tracked study progress and assessed compliance of conduct of clinical trial with regulatory requirements, clinical study protocol, study specific plans, and standard operational practices.
  • Oversaw day-to-day operations, identified and secured needed resources.
  • Created and nurtured collaborations and partnership with internal and outside affiliates.
  • Directed action to ensure high quality clinical research standards are maintained across department functional areas.
  • Delivered the planning and implementation of cross functional project(s) plans and risk mitigations strategies for T1D studies.
  • Contributed to the development and review of study documents including clinical trial protocols, informed consent forms and recruitment materials.
  • Traveled to site engagement meetings for recruitment, resourcing, and resolution purposes.
  • Attend SET meetings and dissent relevant information through regional team meetings.
  • Lead site, regional operations, and vendor calls.
  • Escalation resources for CTA’s, SSU leads, Site Payment Leads, Budget Contract leads, Lead CRA’s, CRA’s, Sites, and Vendors.

Regional Clinical Trial Manager

Icon
09.2021 - 04.2023
  • Lead and managed the conduct of clinical trials from study start up to closeout across assigned countries in accordance with ICH-GCP, SOP’s and applicable local regulations.
  • Provided direction, supervision, and leadership to assigned work groups between local and central teams.
  • Monitored operational performance and efficiency and took action to redirect activities appropriately.
  • Proactively identified risk, implemented risk mitigation strategies, and resolved issues at a regional/country/site level.
  • Collaborated with cross-functional internal and external stakeholders to ensure timely and on budget execution of clinical trial deliverables within the regions.
  • Maintained data quality including consistent review of data metrics, protocol deviations, important protocol deviations (IPDs), eligibility violations, and dosing deviations.
  • Managed and tracked key study matrix to ensure adherence to project milestones.
  • Developed monitoring plans and tools, trained CRA’s, reviewed trip reports, implemented corrective and preventative action plans.
  • Oversaw investigational product: including shipping logistics, overall accountability, and reconciliation.
  • Provided direction for all clinical trial vendors including IVRS, Central Labs, IRB, Imaging, and Central ECG.
  • Created and assessed the feasibility of the site selection process.
  • Actively involved in audits and assisted with CAPA’s as required throughout the life cycle of the study.

Study Management Associate III

AbbVie Inc.
08.2019 - 09.2021
  • Responsible for executing one or more elements of clinical studies in compliance with quality standards (ICH/GCP, Global Regulations, and AbbVie policies and procedures).
  • Assisted the Study Project Manager in leading the cross functional study team.
  • Highly self-motivated and productive in working independently or within a team environment.
  • Prepared Clinical Study Team meetings (Agenda/Minutes).
  • Managed payment process for all clinical trial study sites and vendors.
  • Accounted for regular updates to the cross-functional team and stakeholders on study status; ensure our CTMS is up to date.
  • Assumed the lead on a phase one oncology clinical trial with a successful outcome.
  • Guided the development of the clinical study blueprint/protocol and associated systems and documents (Informed consent forms, eCRFs, IRT, CSR).
  • Maintained the vendor selection, scope development, management, and oversight of external vendors in compliance with AbbVie’s processes and procedures and the applicable regulations.
  • Liable for generating the study related training for the study team, study sites.
  • Proactively identified and resolved escalation issues and concerns.
  • Participated in process improvement initiatives.

Clinical Research Associate Oncology

Syneos Health
02.2015 - 08.2019
  • Lead biweekly Oncology team calls.
  • Provided exceptional verbal and written communication with internal and external contacts to ensure consistent professional and courteous experience.
  • Key contributor of study documents and maintained project tracking systems as required.
  • Worked with other departments to allocate resources accordingly.
  • Performed both on site and remote site visits monitoring activities in accordance with protocol, GCP/ICH Guidelines, and/or other applicable regulatory requirements, and followed appropriate documentation (confirmation, follow-up letters, trip reports and or/ communication logs) as required.
  • Evaluated overall performance of site and site staff.
  • Monitored and interpreted data and identified protocol deviations.
  • Understood and interpreted protocol and regulations to ensure sites are inspection ready.
  • Identified project scope, budgets, timelines and managed objectives.
  • Recommended appropriate follow-up responses, generated queries, and managed resolutions with site personnel.
  • Obtained, reviewed, and processed regulatory and administrative documents from investigator sites.

Education

Bachelor of Arts - Psychology

Rowan University
Glassboro, NJ

Skills

  • Clinical research expertise (20 years)
  • Project management
  • Cross-functional team leadership
  • Mentoring and coaching
  • Process improvement
  • Training development
  • Problem solving
  • Analytical thinking
  • Attention to detail
  • Team development
  • Effective communication
  • Time management
  • Results orientation
  • Client relationship management
  • Adaptability skills
  • Conflict resolution strategies
  • Budgeting and forecasting proficiency
  • Organizational skills

Timeline

Senior Clinical Team Lead

Rho, Inc.
10.2024 - 05.2025

Project Manager

ICON
05.2023 - 10.2024

Regional Clinical Trial Manager

Icon
09.2021 - 04.2023

Study Management Associate III

AbbVie Inc.
08.2019 - 09.2021

Clinical Research Associate Oncology

Syneos Health
02.2015 - 08.2019

Bachelor of Arts - Psychology

Rowan University

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