**Oct****

ANGEL L. KOLINS

**** **** ***** **.

MOUNT PLEASANT, SC 29466

ad3s4l@r.postjobfree.com

843-***-**** OFFICE

843-***-**** CELL

Experienced Global Clinical Operations Manager

Current Assignment as Clinical Operations Lead blinded phase I /II trial(s) and unblinded Sr. CTM Phase III. Countries include Canada, Belgium, France, Germany, Italy, Israel, Estonia, Spain, Finland, Japan, Australia, United Kingdom.

Additional tasks for phase II/III: Amendment and Completed feasibility; PSV review; site selection globally. unblinded Sr. CTM role: prepared sponsor SOPs; preparation of site/CRO training materials; collaboration with cross-functional team; worked closely with Quality and Clinical Supplies: re: unblinding event; proper reporting of unblinded protocol deviations; management of clinical supplies; IRT upgrades/settings; data management; CRO team management. PROFESSIONAL EXPERIENCE:

Consultant to FTE: Assignments:

Moderna, Clinical Ops Lead/Sr. Clinical Trial Manger 04/2021-4/2022 FTE 4/2022-Present

Essential Duties & Responsibilities :

The Sr. Clinical Trial Manager (Sr. CTM) provides clinical trial oversight to the assigned clinical trial(s), which may be complex or high priority, and ensures deliverables are met in terms of quality, compliance and timing. Strong vendor management is critical for this role. This position will work with internal team members, sites, external vendors and CROs. The position may report to the Director, Clinical Operations. This role may work collaboratively on one trial or across several trials to support clinical operations activities

Responsibilities:

Perform day to day management and oversight of assigned clinical trial(s) to ensure deliverables are met in all phases of the trial

Lead the Clinical Trial Team, and support other development teams as Clinical Operations representative as required

Perform and document study level Sponsor Oversight of outsourced clinical activities

Communicate study-status, cost and issues to ensure timely decision-making by senior management

Initiate and manage study-level timelines, including communication to internal and external team members on deliverables

Work closely with other supporting clinical operations team members, if applicable, to execute clinical studies

Draft and/or oversee the drafting of site materials including training, manuals and support documentation

Angel Kolins Curriculum Vitae

Page 2 of 9

Review clinical data to ensure timely entry and readiness for data review meetings

Perform periodic review of clinical data, quality metrics and study deviations

Manage trial feasibility process and oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team

Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate

Review clinical monitoring reports to ensure timely completion and identification of issues

Ensure trial samples are ready to be sent to vendors in order to meet trial deliverables

Complete and maintain internal clinical trial metrics, dashboards and other internal updates

Ensure trial is conducted in accordance with Sponsor and ICH/GCP standards including multiple regions in global trials

Participate in testing of clinical trial systems / databases (i.e. UAT)

Manage invoice and budget tracking for individual studies and provide input into budget forecasting activities

May support additional clinical trial(s) in various capacities (e.g., unblinded clinical trial manager, regional clinical trial manager, etc.)

Participate in clinical operations workstreams related to departmental and operating model related initiatives, develop and maintain strong, collaborative relationships with key stakeholders within and external to Sponsor

Strive for continuous improvement and more efficient ways of working in clinical development

Act as a role model for Sponsor values

Angel Kolins Curriculum Vitae

Page 3 of 9

Ayala Pharmaceuticals

Senior Clinical Trial Manager Oncology Rare Disease (Desmoid Tumors) 12/2020-4/2021 Gannex

Clinical Operations Lead (Nephrology-NASH) 11/2020-3/2021 Primary responsible for Phase I and Phase II Study Start Up and Execution IQVIA Biotech 3/2019-1/20201

Senior Clinical Trial Manager (FTE to Consultant) Oncology/Inf. Dis. ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: Responsible for all activities related to implementation and execution of clinical studies that include: Client Duties/Responsibilities:

Define program targets for clinical monitoring staff and assure work is documented within contracted project scope. Communicate and document all interactions with client as required by SOP

Serve as client advocate

Develop and implement trial specific plans

Team Duties/Responsibilities:

Responsible for assuring needs of clinical sites are met by facilitating clinical monitoring processes, including:

o Support site management activities

o Manage site identification, recruitment, and selection

Work closely with cross functional teams from study start up to study closure

Develop site/monitoring tools and training materials

Review and identify trends in enrollment and data entry at sites and proactively interface with clinical monitoring team and client to identify solutions.

Coordinate and oversee daily operations of cross functional teams

Set and enforce project timelines with the assigned study team

Perform and coordinate remote review of clinical data within EDC system

Review and approve trip reports and follow-up letters within required timeframe.

Manage project milestones and proactively address deficiencies

Attend and provide information at monthly projections meetings

Attend and provide information at weekly client teleconferences/team meetings.

Identifying Out of Scope activities and assuring that such activities do not begin until the client provides authorization

Manage Clinical Operations Team:

Define and implement functional standards, goals, and expectations with clinical monitoring team Documentation Duties/Responsibilities:

Assure that the appropriate CRO and/or sponsor SOPs are followed

Ensure all project documentation is appropriately filed per SOPs

Perform audit readiness preparation and responses Budget/Contract Duties/Responsibilities:

Define the scope of work with the client and clinical monitoring team

Identify and generating changes in scope and notify client of potential changes in scope Angel Kolins Curriculum Vitae

Page 4 of 9

ATLANTIC CLINICAL RESEARCH, SCorp Mount Pleasant, SC 10/2015-3/2019 Provide Clinical Consultant Services to CRO/Biotech/Devise/Pharma Industry-Phase I-IV Innovative Trials, Inc.-Rheumatology-Phase III 10/2018-3/2019 Clinical Enrollment Manager- consultant responsible for site activation and the successful recruitment of trials. (allocation 20-25%)

Pearl Therapeutics-Pulmonology-Phase III 03/16-11/2018 Sr. Project Manager-consultant focusing solely on Trial Recruitment (allocation 10-15% Mar2016 to Jan2018; allocation Jan to Nov2018 50-75%)

Quality Resource Solutions-Ophthalmology-Phase II

Sr. Quality Auditor-consultant 10/2018-11/18

Assigned 5 regional Site Audits for Large Biotech (to be performed by end of November/allocation 25%) Pfizer- Oncology-Phase II/III (Lung and Prostate) 11/17-5/18 Sr. Study Manager- consultant with a focus on Inspection Readiness and Phase III interim database lock. NCGS, CRO on assignment to TEVA – CNS (Migraine and Headache)-Phase III 4/2016-11/17 Sr. Clinical Trial Manager – Consultant managing US and Canada for a Global Phase III trial. Direct clinical operations management with TEVA.

TKL Research, CRO on assignment to Cutanea-Dermatology (Rosacea)-Phase II/III 10/2015-4/2016 Clinical Trial Manager- focus on US and CANADA study start-up Other Responsibilities in the above Management Roles:

Management of complex studies global trials

Budget and Contract set up and management

Investigation Product management

Study Start Up

Feasibility Management, Summary Reporting, Finalization

Regulatory Review

Vendor Management inclusive of: CRO/Monitoring, Central ECG; Central Lab; ePRO; Central EEG; Central IRB; Drug Depot; Data Management Vendor; IVRS/IWRS Vendor

Set up; oversee and train staff on clinical systems

Work directly with Sponsor Regulatory, Statistical and Safety Management teams

Safety Reporting

Protocol Deviations

CAPAs

Interim Analysis

Line Manager of up to 28 CRAs

Preparation, Presentation, Conducting:

Investigator Meeting(s)

Study Plans and Documents:

Feasibility Plan

Monitoring Plan

Project Management Plan

Angel Kolins Curriculum Vitae

Page 5 of 9

Safety Plan

TMF Management Plan

Trial and Site Budgets

Source Documents

ICF templates

User Acceptance Training (UAT)

Creation and Distribution of Trial Newsletters

Study Enrollment & Contingency Recruitment Planning

Data Base Locks (Interim; Rolling and Final)

Review & Finalize monitoring trip reports

Performed inspection readiness quality reviews of TMF prior to FDA Audit

Interface with other Clinical Teams and Site(s) to ensure alliance and compliance to:

Feasibility Plan

Protocol

Monitoring Plan

Resolution of trial, site and/or monitoring related issues

Communication/Training of study information to the CRAs

Managed CTMS and TMF vendor solely inclusive of:

Training all study staff on system and system updates

Daily CTMS compliance control

Preparing and Distributing Upper Management Summary reports PEARL THERAPEUTICS, INC., Redwood City, CA 01/2015 – 10/2015 Director, Clinical Operations – Pulmonology -Phase III

Led shared clinical operations functions including clinical monitoring, project management, strategic alliance management, vendor selection and oversight, clinical operations quality and continuous improvement, document management, clinical trial administrative support, and clinical systems administration

Established collaborations with key stakeholders internally, which included a complex matrix- based environment, and externally, KOLs, Investigators, and strategic partners

Led the team to develop standard processes and systems to manage tasks, and ensured division of responsibilities for efficiency balanced by cross-training to manage surges in workload across the organization

Represented the organization to senior leadership and served on cross-functional teams which supported initiatives related to quality, submission readiness, IT systems, procurement, and transparency

Worked across functional areas to establish a strategic outsourcing plan and directed the selection and management of CROs and other vendors for the conduction of clinical trials Associate Director of Clinical Operations-Phase IIb/III 01/2013-01/2015

Managed the execution of all clinical trials with the assigned trial teams and vendors from study start-up to database lock

Managed the clinical administration support functions including the clinical trial assistant group and clinical trials systems (e.g. CTMS and eTMF)

Angel Kolins Curriculum Vitae

Page 6 of 9

Provided oversight responsibilities for clinical monitoring processes and training

Developed, implemented, and maintained key clinical trial objectives to ensure adherence to standards and all applicable regulations and guidelines

Worked directly with the Senior Director Clinical Operations and shared responsibility of meeting corporate objectives and timelines

Managed direct reports as required by the organizational needs of the Clinical Operations Department

Clinical Operations Manager-Consultant-Phase IIa/IIb 05/2010-01/2013

Manages Clinical Trial Assistants

Provides feedback, reviews for CTAs and sites

Acts as a CRA Training Resource/ Pearl Monitoring Subject Matter Expert (e.g. Technology systems, process, etc)

CRA monitoring report review and approval

Management of CRA Findings/Issue Escalation/CAPA

Oversees CRA co-monitoring/shadowing

Communicates and coordinates trial start-up, conduct, and close-out administrative activities with study site personnel, vendors and other key stakeholders

Management and review of trial regulatory documents

Initiates, maintains, and reconciles the sponsor study files including electronic trial master files

(eTMF)

Organizes and maintains study tracking systems (including CTMS) and tools to support the conduct of a clinical study from start-up to close-out

Maintains accurate tracking and reporting of study timelines and other metrics

Supports scheduling and coordination of project team meetings

Manage Study Payments Activities (site and vendors)

Manages and tracks clinical/non-clinical supplies

Generates management reports for internal communication and progress updates.

Supports investigator meeting activities, including planning, preparing meeting materials and on- site meeting implementation.

Supports and Collaborates with manager on the development of study specific plans and/or processes

Clinical Research Consultant -Phase I/II 06/2009-

05/2010

Management of Site Selection, Study Start-Up, Feasibility, Regulatory Review

Monitored investigative sites

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

Performed drug accountability for all products

Managed TMF for assigned trial sites

Angel Kolins Curriculum Vitae

Page 7 of 9

Reviewed regulatory documents for completeness prior to Sponsor/FDA submission

Conducted Site Staff and CRA training

ATLANTIC CLINICAL RESEARCH, SCorp Mount Pleasant, SC 1997–2013 Provide Clinical Consultant Services to CRO/Biotech/Devise/Pharma Industry-Phase I-IV Consultant Role Description(s)

Project Manager/Clinical Trial Manager/Lead CRA-Consultant

Acted as primary management and 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

Planed and set project metrics

Took part in Investigator Meetings set-up and presentations

Conducted and approved 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

Senior CRA - Consultant

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

Performed drug accountability for all products

Managed TMF for assigned trial sites

Reviewed regulatory documents for completeness prior to Sponsor/FDA submission

Conducted CRA trainings

Quality Auditor - Consultant

Conducted pre-FDA site audits and Quality Audits within specified timeframes for Biotech, Pharmaceutical and Device trials

Angel Kolins Curriculum Vitae

Page 8 of 9

Directed sponsor communication regarding audit reporting, findings, and resolution NCGS & ASSOCIATES, Charleston, SC 1996-1997

Project Manager

Allocated and resourced 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 (Contractor)

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 1993-1994

Reagents College, New York, NY and Trident Technical, Charleston, SC B.S. in Chemistry 1992

College of Charleston, Charleston, SC

Angel Kolins Curriculum Vitae

Page 9 of 9

LICENSES AND CERTIFICATIONS

Certification in Project Management – On-Line Barrett International June-July 2015

Certified Clinical Research Associate-Society of Clinical Research Sept. 1996 SKILLS/THERAPEUTIC EXPERIENCE

Examples of Therapeutic Experience:

Cardiology

CNS

Endocrinology

ENT

Infectious Disease

Nephrology

Neurology

OB-GYN

Oncology

Ophthalmology

Orthopedics

Pediatrics

Psychiatry

Psychology

Pulmonology

Women’s Health

Medical Devices:

Orthapedic Devices

Cardiac Devices

Pregnancy Prevention Devices

Examples of Clinical Data Management Systems utilized: ClinTrial, ClinAccess, Clintrace, eSafetyNet, Medidata Rave (EDC and CTMS); iDataFax (IWRS/EDC); Clindex; eClinical; Oracle Clinical (EDC and CTMS); SimpleCTMS; SharePoint; Catalyst CTMS; Balto; Trial Interactive (TMF/CTMS)

Angel Kolins – 22Oct2020

Contact this candidate