Clinical Trial Manager Lead Clinical Research Associate
Resume:
Curriculum Vitae
ANGEL(A) L. KOLINS, CPM, CCRA
**** ********* ***** ** ******** (Charleston), SC 29466 843-***-**** ***********@******.***
Respected and results oriented Clinical Research Professional with a proven track record of delivering successful global drug development programs by driving quality and efficiency through collaborative communications and thorough use of clinical technology. Strengths lie in process improvement and business efficiencies, as well as coaching and mentoring skills. Seeking a role within Clinical Operations as Trial Manager/Lead CRA/CRA. Role Specific Qualifications:
Experienced: Global Sr. CTM / Sr. And Lead CRA Blinded and Unblinded Phase I/II/III /IV Skills:
• Adaptability (Technology/Conflict/Data Driven)
• Effective Communication (Listen/Learn/Train)
• Leadership (Critical & Strategic Thinking/Analysis/Initiative)
• Collaboration (Reliability/Professional/Deliver)
• Problem-Solving (Involvement/Deliver)
• GCP/ICH/GLP/GMP
• Investigator Site Engagement
• Risk Management (Inception-Completion/Analysis)
• Study Plan Execution
• Budget Analysis
• CTMS/TMF/UAT- Clinical Application utilization
RECENT ACCOMPLISHMENTS (2021-2025)
• Operational Lead for large Biotech Initial European Regulatory (EU-CTIS) submission with approval
• Completion Phase I Dose Escalation Trial: 8 tiers (6 months).
• Manage SSU for additional 125 sites/ PIII global trial (6 months 80% in 4 months)
• Phase III Audit preparation, management of safety reporting, add-on site (100) SSU as recruitment rescue
• Phase I/II: Completion of Feasibility; ICF; Budget; Contract; PSV/SIV; Vendor Plan execution (4 months)
• Lead Strategist for Unblinded Team Implementation (SOP/Training/Supply and Depot Management/Unblinded Safety/Unblinding Reporting) (6 months)
• CAPA: Closed >100. Produced CAPA decision making output; data impact; trial impact analysis. Included storyboards, cross-functional training. (CAPAs: Site/Client/Vendor outcome)-(4 months)
• Initiated and rollout of Global Collaboration Forum (GCF), educating and sharing best practices (4 months)
• Developed and executed a training curriculum on client/vendor Collaboration & Partnership Abbreviated THERAPEUTIC EXPERIENCE
Cardiology; Cardiopulmonary; CNS; Neonatal; Endocrinology; ENT; Infectious Disease; Nephrology; Neurology; OB-GYN; Oncology (CAR-T; Solid and Liquid); Ophthalmology; Orthopedics; Pediatrics; Psychiatry; Psychology; Pulmonology; Women’s Health; Vaccine; Surgical ICU; Rare Disease; Orthopedic Devices; Cardiac Devices; Pregnancy Prevention Devices; Ophthalmology Implants; Diabetes Management Devises OTHER RELEVANT EXPERIENCE
• Business development plans and BID defense strategies
• Budget plans, staffing & resource projections
• Facilitation for conflict resolution planning-cross functional teams
• Facilitation for study and program lessons learned and best practices
• Management for collaborative and cross-functional teams Curriculum Vitae
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• Proficient in operating and clinical systems:
• MS Office; MS Project; Veeva Vault (eTMF/CTMS/Training/Regulatory); Endpoint; ClinTrial, eSafety, Medidata Rave
(EDC and CTMS); eClinical; SimpleCTMS; SharePoint; Catalyst CTMS; Balto; Trial Interactive (TMF/CTMS) LINE MANAGEMENT EXPERIENCE
• Annual/bi-annual planning and performance reviews, Talent Reviews
• Career development forecast and planning
• Personal Improvement Plans (30, 60, 90-day plans)
• Training, coaching and mentoring in support to enhance individual and team performance Example: Long Term Consulting Assignments:
TAP/Takeda: CRA, SR. CRA, Lead CRA: 7 years (Oncology, Gastroenterology; Women’s Health; CNS) Duramed: CRA/Auditor: 6.5 years (Women’s Health; Gynecology) Mitsubishi: Site Auditor: 3 years
Abt Associates: Global CRA/Site Auditor; Investigator Initiated Trials; Data Abstraction: 4 years Pearl Therapeutics: 5 years
BMS: 2.5 years (CNS/Cardiology/Oncology)
PROFESSIONAL EXPERIENCE
Nov2023-Present
Clinical Trial Manager/Lead-Sr. CRA/Project Quality Atlantic Clinical Research Consortium, SCorp.-Owner on Assignment
• BioNTech: Sr. CTM- Infectious Disease: Vaccine for TB- Phase I
• Chiesi: Sr. Lead Manager- Pulmonology: COPD/Asthma Phase II-III.
• DevPro: Blinded Lead SR. CRA and Unblinded Sr. CTM: Pulmonology: COPD Moderna-Global Vaccine (Zika -Phase I/II and CMV Phase III) Apr2021-Nov2023 Sr. Clinical Trial Manger
Lead Blinded CTM phase I /II trial(s)
Unblinded Sr. CTM Phase III)
• Vendor Oversight: CRO / CMO / IRT/ EDC / Clinical Supplies
• Study Start-Up (130+ sites) managed feasibility; PSV review; site selection globally (increase is sites supporting recruitment)
• Prepare sponsor unblinded SOPs-draft completion 3 months
• Preparation of site/CRO training materials
• Additional Leadership Management Collaboration with Quality and Clinical Supplies: CS issue identification – and execution- 7 days
• Oversee unblinding events; proper reporting of unblinded protocol deviations; management of clinical supplies; IRT upgrades/settings; data management; CRO team management- continuous
• Sponsor Oversight of outsourced clinical activities documentation advancements – 6 months (blinded monitoring and risk management)
• Communicate study-status, cost and issues to ensure timely decision-making by senior management Curriculum Vitae
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Myovant
Lead uCRA/uCTM/Audit Preparation (Women’s Health) Oct2021-Mar2022
• Inspection Readiness and Phase III interim database lock
• Unblinded Lead CRA/CTM -collaboration with all unblinded staff on trial to support data base lock and unblinded eTMF
• Clinical trial supply, laboratory, specimen reconciliation
• Blinded CTM responsible for supporting database lock with sites, data management, statistics, medical monitors Ayala Pharmaceuticals Dec2020-Apr2021
Senior Clinical Trial Manager Oncology Rare Disease
• Study Start-Up and Recruitment / Support all US/Canada activities (Allocation ~25%) Ascletis/Gannex Nov2020-Mar2021
Clinical Operations Lead (Hepatology)
• Primary responsible for Phase I and Phase II Study Start Up and Execution and Close-Out. Dose Escalation Trial. Prepared Phase III protocol. Rapid enrollment and database lock (allocation ~50-75%) PPD Jul2020-Mar2021
Lead CRA/Unblinded CTM (Respiratory/Infection Disease/Oncology)
• Responsible for integrated monitoring plan execution and collaborative pandemic data collection models
• PPD CRA training and oversight
• Sponsor liaison- first line of contact
• Unblinded eTMF; Report reviews
IQVIA Biotech Mar2019-Jan2021
Sr. Clinical Trial Manager /CRA Manager- (Oncology / Infectious Disease)
• Responsible for the successful planning, implementation and execution of contract clinical monitoring activities
• Work closely with Project Managers to define program targets for clinical monitoring staff and ensure work is documented within contract project scope
• Interact directly with sponsor clients and serve as advocate
• Review project budgets, monitoring costs, potential overruns and propose/implement cost effective solutions
• Assure that appropriate and/or sponsor SOP execution
• Ensure CRAs assigned to team receive therapeutic and project-specific training
• Manage quality and regulatory compliance among clinical monitoring teams and investigational sites
• Manage project milestones and proactively address deficiencies
• Attend and provide information at weekly client teleconferences/team meetings Innovative Trials, Inc.-(Rheumatology) Oct2018-Mar2019 Clinical Study Startup/Enrollment Manager; CRA Training Support
• Site activation and the successful recruitment of 3 trials (allocation 20-25%)
• CRA Trainer focus on recruitment deliverables; recruitment materials Quality Resource Solutions-(Ophthalmology) Oct2018-Nov2018 Sr. Quality Auditor
• Assigned 5 regional Site Audits for Large Biotech Pfizer- (Oncology) Nov2017-May2018
Sr. Study Manager/Lead CRA
• Inspection Readiness and Phase III interim database lock
• US Lead CRA / CRA training
• Site engagement and site monitoring
• TMF Audit preparation
Pearl Therapeutics-(Pulmonology) Mar2016-Nov2018
Sr. Project Manager
• Focusing solely on Trial Recruitment (allocation 10-15% Mar2016 to Jan2018; allocation Jan to Nov2018 50-75%)
• Oversee CRA-Site engagement
Curriculum Vitae
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• Trial site direct sponsor representative
NCGS, CRO– CNS (Migraine and Headache)-Phase III Apr2016-Nov2017 Sr. Clinical Trial Manager –
• Managing US and Canada Sites and Monitoring Team for a Global Phase III trial.
• Direct clinical operations collaboration with client management team at TEVA TKL Research, CRO a-Dermatology (Rosacea)-Phase II/III Oct2015-Apr2016 Clinical Trial Manager-
• Study Set-up, Feasibility, Monitoring, Project Management, Safety, TMF, Trial and Site Budgets, Source Documents, ICF Template
• Direct clinical operations collaboration with client management team at Cutanea
• Study Enrollment & Contingency Recruitment Planning
• Data Base Locks (Interim; Rolling and Final)
• Review & Finalize monitoring trip reports
• Site FDA Audit preparation and on-site representative
• Managed CTMS and TMF Daily CTMS compliance control
• Preparing and Distributing Upper Management Summary reports PEARL THERAPEUTICS, INC., Redwood City, CA 2009 – Oct2015 Title: Director, Clinical Operations: Jan2015- Oct2015 Title: Associate Director of Clinical Operations: Jan2013 -Jan2015 Title: Clinical Operations Manager 2009-2013-Consultant Clinical Operations and Business Leadership:
Developed and lead a high performing clinical operations team, with significant corporate financial and acumen impact, with the responsibility for identifying and implementing scalable business processes for effective, quality and investigator clinical trial execution. Lead to NDA 7 Completed Phase I trials
4 Completed Phase (Global)
8 Completed Phase IIb trials (Global)
7 Completed Phase III (Global)
4 Ongoing Phase III (Global)
ATLANTIC CLINICAL RESEARCH, SCorp Mount Pleasant, SC 1997–2013 Provide Clinical Services to CRO/Biotech/Devise/Pharma Industry-Phase I-IV Title Summary: Project Manager/Clinical Trial Manager/Lead CRA/Sr. CRA/Quality Auditor Responsibilities:
• Primary contact for the trial team, vendors, and consultants
• Delivered project and trial team training
• Provided overall site management/ supervision and issue resolution
• Managed site contracts and budget
• Planned and set project metrics
• Presentation / Presenter at Investigator Meetings; assisting with meeting set-up
• Conducted User Acceptance Testing
• Monitored investigative sites for quality assurance
• Devised CAPAs for non-compliant investigative sites and trial team
• Tracked and presented on progress of the project to all stakeholders to define project progress, problems, and solutions
• Monitored investigative sites to conduct Phase I-Phase IV and post-marketing clinical trials in accordance with procedures set forth by the FDA, CFR, ICH Guidelines, GMP’s and GCP's along with Sponsor SOP’s
• Performed Investigator Evaluation for site selection
• Monitored investigational sites for Qualification/Initiation/Interim/Close-out visits
• Attended and conducted weekly conference calls, prepared agenda, followed up on questions/concerns
• Prepared detailed reports for the physicians and medical sponsor team Curriculum Vitae
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• Performed drug accountability for all products
• Managed TMF for assigned trial sites
• Reviewed regulatory documents for completeness prior to Sponsor/FDA submission
• Conducted CRA training
• Conducted pre-FDA site audits and Quality Audits within specified time limits for Biotech, Pharmaceutical and Device trials
• Directed sponsor communication regarding audit reporting, findings, and resolution NCGS & ASSOCIATES, Charleston, SC 1996-1997
CRA / Project Manager
• Allocated and resourcing of staff
• Negotiated and tracked CRO/ sponsor budget and contracts
• Trained CRAs
• Took part in the process of site identification and selection
• Prepared and finalized monitoring study guidelines and plan
• Conducted weekly team and sponsor meetings
• Attended to all personnel and study specific issues (line/change management)
• Conducted pre-FDA site audits
• Management vendors (Data Management; Central IRB; IVRS) ELI LILLY & COMPANY, Indianapolis, IN 1995-1996
Regional Clinical Research Associate/Monitor
• Monitored Phase II-Phase IV clinical trials in accordance with FDA, GCP's, CRO and sponsor guidelines and SOP's
• Performed pre-study evaluations, recruitment of investigators, and QA review of regulatory documents
• Conducted qualification, initiation, routine monitoring and close-out visits
• Resolved data queries and performed data close-out query audits for than 20 sites on the East Coast COLEMAN RESEARCH CORPORATION/ MEDICAL UNI. OF SOUTH CAROLINA 1993-1995 Project Manager/Clinical Research Coordinator
• Acted as the Clinical Research Coordinator for Phase II-Phase IV clinical trials for a centralized clinical research center at the MUSC: Institutional Review Board submissions
• Recruited and informed patients of study procedures and objectives, including patient scheduling and investigator scheduling
• Performed patient protocol evaluations and procedures when indicated; biological sampling and shipping; CRF completion; monitored and scheduled site visits, and query resolution PHARMACEUTICAL DEVELOPMENT CENTER 1992-1993
Chemist
• Performed analytical research, development and stability analysis of pharmaceutical products utilizing Chromatography (HPLC, GLC, and TLC), Spectroscopy (Ultraviolet/Visible and Infrared) and Dissolution standard methods
EDUCATION AND TRAINING
Graduate Courses in Environmental Chemistry and Scientific Business Management 1995 Medical University of South Carolina, Charleston, SC Nursing School (Class Instruction/Shadowing) 1993-1994 Reagents College, New York, NY and Trident Technical, Charleston, SC B.S. in Chemistry / B.A. Psychology 1988-1992
College of Charleston, Charleston, SC
Licenses and certifications
• Certification in Project Management – On-Line Barrett International June-July 2015
• Certified Clinical Research Associate-Society of Clinical Research Sept. 1996
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