Summary
Overview
Work History
Education
Skills
Accomplishments
Languages
Publications
Indications
Software
Timeline
8d
Steven P.  Bright

Steven P. Bright

Idaho Falls,USA

Summary

To secure a position in clinical study conduct and management, leveraging extensive experience in clinical research across phases 1-4, from laboratory discovery to regulatory submissions. Skilled in managing global clinical trials, ensuring compliance with ICH GCP and regulatory requirements, and fostering collaborative team environments to achieve project goals. Experienced in academia, government, and private sectors, including full-service CRO and sponsor roles. Indications including endocrinology, gastroenterology, hematology, immunology, infectious disease, psychiatry, and respiratory with a focus on oncology and hematology.

Experienced with overseeing clinical trials to ensure adherence to regulatory guidelines and protocols. Utilizes strong project management skills to streamline trial processes and enhance operational efficiency. Track record of effectively managing cross-functional teams and mitigating risks in clinical research.

Clinical research professional with proven track record in managing complex clinical trials. Known for fostering collaborative environments and driving project success. Reliable team player who adapts to evolving project needs and excels in protocol development and trial execution.

Overview

30
30
years of professional experience

Work History

Senior Clinical Trial Manager

ICON
05.2021 - 06.2025
  • Customer Relations (Internal & External)
  • Interfaces with other Functional Leads, Executive team members and vendors as required to ensure clinical operations outcomes are achieved
  • Serves as primary liaison for clinical monitoring issues, interacting with vendors and other functional areas, escalating as required
  • Participates in all study related meetings, assisting with presentations as required -Contributes to Business Development activities participating in proposals and bid defenses as needed.
  • Identifies metrics and trends across team members, countries, regions and uses the information to promote improvement in quality and consistency of execution.
  • Collaborates with Quality Assurance (QA) to identify sites needing corrective and preventative action plans, responds completely and accurately to audit reports, provides team with project-specific audit process to ensure adequate preparations/reviews of all audit responses prior to submission to internal clinical review team/QA and then Sponsor Organizes project specific compliance plans for key processes, tools and systems
  • Oversees filing of Essential Documents in the electronic Trial Master File to ensure CRO and investigator obligations are being met and follow applicable local regulatory requirements and ICH guidelines.
  • Quality – Training & Development -Reviews, contributes and approves project specific plans, documents and tools for the CRO clinical team.
  • Plans, oversees and conducts initial and ongoing training for the relevant study staff on clinical project specifics
  • Analyzes data related to sites activation, monitoring, data retrieval and close out to identify issues and risks to clinical deliverables; develops contingency and mitigation plans to minimize risks; communicates risks & mitigation strategies.
  • Supports the CRO CTMs and CRAs with site training activities and provides suggestions and solutions to site issues where applicable.
  • Ensures all PRA project reporting systems are up to date for clinical activities at the project level
  • Oversees the CRO team to ensure all initial or amended trial information is submitted, approved and filed in accordance with the trial protocol, local regulations, ICH-GCP and any other processes or procedures governing the clinical trial.
  • Reviews site visit reports within agreed turnaround times and ensures tracking, follow up and resolution of site issues
  • Identifies opportunities to improve training, execution and quality control across the team
  • Liaises with relevant staff to provide data as required for clinical operations performance metrics and project status metrics
  • Works with the relevant staff to identify data related issues and risks to clinical activities; develops contingency and mitigation plans to minimize risks and escalates to Vendors /senior leadership as appropriate.
  • Perform periodic reviews of the CRO eTMF/TMF to ensure adherence with standards and compliance with the relevant regulations and guidelines
  • Works with vendors to revise scope of service agreements, budgets, plans and detailed timelines, and ensure that performance expectations are met
  • Support financial management of the study which includes review and approval of site and vendor invoices
  • Supports risk management initiatives
  • Supports audit/inspection activities as needed
  • Maintain clinical trial registry entry/updates, as required
  • Provides mentorship/guidance to junior team members or cross-functional colleagues on study processes/study requirements.
  • Oversees the start-up and clinical teams within the CRO
  • Oversees the monitoring activities for the clinical study and communicate consistently with the Mirati clinical team providing project objectives, expectations and status updates.
  • Works with the CRO team to set priorities
  • Takes the initiative to provide clear expectations to relevant CRO staff ( this may include but is not limited by Country Start Up Specialist (CSS), Global Regulatory Affairs Lead (GRAL), Local Regulatory Affairs Lead (LRAL) and In-House Clinical Research Associate (IHCRA)) to ensure the successful activation of trial sites according to time, quality/scope and budget parameters
  • Reviews and approves the communication plan to ensure effective communication plans are place for the CRO team
  • Works closely with the COSL to facilitate a cross functional team.
  • Provides Project Oversight and Leadership for Clinical Deliverables: Vendor (e.g., CRO, Biometrics, IXRS, PK/Central Lab, eTMF, Safety) oversight for adherence to budget, timelines and organizational objectives of individual protocols/programs
  • Develop strong vendor and site relationships and ensure continuity of relationships through all phases of the trial
  • Obtains and maintains an in-depth understanding of the study protocol and related procedures in order to contribute strongly to study team knowledge by sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required
  • Coordinates and manages various tasks in collaboration with other sponsor roles to achieve site readiness, such as study materials and approval for drug shipping/receipt according to procedure
  • Performs timely review of monitoring reports from CRO and associated deliverables demonstrating sponsor oversight.
  • Accomplishments: Successfully managed global studies, maintained compliance, and delivered projects on schedule and within budget.

Senior Clinical Project Manager

Chiltern
08.2017 - 05.2021
  • Provided functional leadership for clinical operations and analytics teams during study initiation, conduct, and close-out for global phase I-IV trials.
  • Ensured data quality, regulatory compliance, and timely delivery of project milestones across North/South America, Europe, and Asia. Proactively identifies, resolves/mitigates and escalates risks and/or issues. Adheres to standard procedures and processes.
  • Coordinated preparation of study files for FDA review and supported IND submission processes using storyboards.
  • Accomplishments: Streamlined processes for FDA submissions, enhancing study readiness and compliance.

Senior Clinical Project Manager/Clinical Lead Manager

Quintiles
08.2011 - 08.2017
  • Led global clinical study teams, managing internal/external teams and vendors to meet project timelines and budgets.
  • Served as primary liaison with sponsor teams, establishing integrated plans and ensuring accountability for clinical team results.
  • Tracked study progress, provided training, and facilitated team communication to support milestones.
  • Contributed to proposal development and sales presentations.
  • Accomplishments: Coordinated documentation for multiple IND submissions, ensuring regulatory compliance.

Senior Clinical Team Lead

Quintiles
08.2006 - 08.2011
  • Managed clinical monitoring teams for global trials, developing tools and processes for accurate source data review.
  • Collaborated with functional groups to track and achieve study milestones.
  • Supported budget development and proposal preparation for new study opportunities.
  • Accomplishments: Enhanced clinical processes, improving efficiency and compliance across studies.

Clinical Research Associate

Quintiles
05.2002 - 08.2006
  • Conducted site monitoring, including source data verification, study medication accountability, and site file reviews per GCP guidelines.
  • Prepared timely progress reports and resolved site issues to meet study goals and IND submission deliverables.
  • Accomplishments: Successfully supported IND submissions through effective site management.

Advanced Research Specialist

Dianon Systems, Inc.
05.1998 - 05.2002
  • Coordinated NIH-funded diagnostic development studies for urological diseases, including bladder and prostate cancer.
  • Managed protocol preparation, database management, statistical analysis, and tissue culture lab operations.
  • Prepared Material Transfer Agreements for patented oncology research cells.
  • Accomplishments: Achieved proficiency in 2D gel electrophoresis and experimental design, contributing to oncology research advancements.

Microbiologist II

Oklahoma Department of Health
05.1996 - 05.1998
  • Performed diagnostic testing for bacterial and viral agents in a public health laboratory, adhering to GLP and CLEA standards.
  • Managed laboratory supplies and completed Biosafety Level 3+ training.
  • Accomplishments: Achieved department certification in public health laboratory testing.

Research Assistant

University of Oklahoma Health Science Center
05.1995 - 05.1996
  • Conducted pre-clinical research on HIV infectivity tissue modeling, including PBMC isolation and monoclonal antibody development.
  • Completed Biosafety Level 2+ training for HIV sample handling.
  • Accomplishments: Contributed to monoclonal antibody development in mouse models.

Education

B.S. - Molecular Biology Biochemistry

University of Idaho
Moscow, ID
01-1995

Bachelor of Science - Microbiology

University of Idaho
Moscow, ID
01-1995

Skills

  • Clinical Trial Management: Phases I-IV including transitional, global study execution, regulatory submissions Protocol and ICF development Study plan development
  • Compliance: ICH GCP, SOPs, FDA regulations, EUCTR, GLP, CLEA
  • Project Management: Risk mitigation, budget development, cross-functional team leadership, vendor contracting and management
  • Technical: Database management, statistical analysis, 2D gel electrophoresis, tissue culture, monoclonal antibody production
  • Software/Study Systems: ClinTrial, Oracle Empirica Signal, Medidata RAVE, Oracle Clinical, MS Excel, MS Project, Veeva Vault TMF/CTMS, Firecrest, Clinphone IVRS Systems
  • Training: Biosafety Level 2 and 3, mentoring, team leadership
  • Adverse event reporting
  • Clinical data management
  • Training and mentoring
  • Clinical trial oversight
  • Patient recruitment
  • Customer focus
  • Document review
  • Audit preparation
  • Investigator relations
  • Site selection
  • Pharmacovigilance
  • Protocol development
  • Stakeholder communication
  • Study design
  • Results-oriented
  • Clinical monitoring
  • Ethics committee submissions
  • GCP training
  • Feasibility analysis
  • Regulatory submissions
  • Site monitoring
  • Standard operating procedures
  • Fluent in english
  • Data management
  • Study coordination
  • Good clinical practice
  • Clinical operations
  • Study documentation
  • Detailed documentation
  • Teamwork and collaboration
  • Problem-solving
  • Time management
  • Attention to detail
  • Leadership skills
  • Problem-solving abilities
  • Multitasking
  • Reliability
  • Excellent communication
  • Critical thinking
  • Adaptability and flexibility
  • Patient education
  • Study protocols
  • Informed consent
  • Site management
  • Specimen handling
  • Safety reporting
  • Medication dispensing
  • Research experience
  • Medical terminology
  • Self motivation
  • Interpersonal skills
  • Analytical thinking
  • Trial management
  • Conflict resolution
  • Risk assessment
  • Data collection
  • Professionalism
  • Interpersonal communication
  • Budget management

Accomplishments

  • Collaborated with team of [Number] in the development of [Project name].
  • Documented and resolved [Issue] which led to [Results].
  • Achieved [Result] through effectively helping with [Task].
  • Used Microsoft Excel to develop inventory tracking spreadsheets.

Languages

English
Native or Bilingual

Publications

  • 1. Gilbert, S., et al. (2003). Evaluation of DD23 as a Marker for Detection of Recurrent Transitional Cell Carcinoma of the Bladder in Patients with a History of Bladder Cancer. Urology, 61(3).
  • 2. Ellison, L., et al. (2002). Cost-Benefit Analysis of Total PSA, Free/Total PSA and Complexed PSA for Prostate Cancer Screening. Urology, 60(4 Suppl 1).
  • 3. An, G., et al. (2000). Cloning and Characterization of a Novel Gene UROC28 that is Differentially Expressed in Prostate Cancer. Cancer Research, 60.
  • 4. An, G., et al. (1999). Cloning of Human Prostate-Specific Transglutaminase (pTG) Gene Promotor: Tissue Specific Expression and Down Regulation in Metastatic Prostate Cancer. Urology, 54(6).

Indications

  • Oncology (7yrs): Colorectal, Ovarian, Breast
  • Project Manager
  • Clinical Lead
  • Hematology (10yrs): Leukemia (All & MDS), Lymphoma (CLL & DLBCL)
  • Immunology (2yrs): Crohn’s Disease, Rheumatoid Arthritis
  • Psychiatry (2yrs): Major Depressive Disorder
  • Rare Disease (1yr): PNH
  • Infectious Disease (5yrs): Otitis Media, Hepatitis C
  • Clinical Research Associate
  • Respiratory (4yrs): Perennial Rhinitis, Moderate/Severe Asthma
  • Endocrinology (2yrs): Type 1 Diabetes

Software

MS Word

MS Excel

MS Project

MS PowerPoint

Timeline

Senior Clinical Trial Manager

ICON
05.2021 - 06.2025

Senior Clinical Project Manager

Chiltern
08.2017 - 05.2021

Senior Clinical Project Manager/Clinical Lead Manager

Quintiles
08.2011 - 08.2017

Senior Clinical Team Lead

Quintiles
08.2006 - 08.2011

Clinical Research Associate

Quintiles
05.2002 - 08.2006

Advanced Research Specialist

Dianon Systems, Inc.
05.1998 - 05.2002

Microbiologist II

Oklahoma Department of Health
05.1996 - 05.1998

Research Assistant

University of Oklahoma Health Science Center
05.1995 - 05.1996

B.S. - Molecular Biology Biochemistry

University of Idaho

Bachelor of Science - Microbiology

University of Idaho