Regulatory Affairs Project Manager

Melisa G. Clark, MS, CCRP, RAC US Email: ***********.********@*******.***

*** *. *** **. ********* Email: ******.**************@*****.*** Little Rock, AR 72205 Phone: +1-501-***-****

Professional Experience:

Mar 2023-Jan 2024: Senior Regulatory Affairs Manager - WEP Clinical, Little Rock (remote)

Provided guidance on current Managed Access Programs (MAPs) including Expand Access Programs (EAPs), Compassionate Use Programs (CUPs), and Post-Approval Named Patient Programs (PA-NPPs) regulations and guidance

(US, EU, UK & ROW)

Provided guidance on current open-label extension trials and post-trial access program regulations (US)

Provided guidance and support with regards to domestic license regulations and requirements (US, UK & IE)

Maintained domestically held licenses from the competent authorities (US)

Represented regulatory in internal projects teams, providing guidance and support and ownership of tasks assigned

Served as line manager of Regulatory Affairs staff including leadership, oversight, training, and development

Stayed up to date with all applicable regulatory changes towards MAP product supply, labeling, real-world data collection, safety reporting and other relevant regulations

Understood and communicated the impact of new, existing, and pending regulations, guidelines, and standards

Drafted and maintained regulatory policies, procedures, and SOPs as required

Worked to current GxP guidelines and within the company framework of its Quality Management System

Supported in the growth of the regulatory database of country-specific information

Provided regulatory information to senior management to assist with the overall project design for clients

Participated in client meetings and provided regulatory advice as part of the overall project design

Supported Business Development and Project Management teams with MAP project-specific regulatory guidance

Supported the Project Management team with individual MAP submissions as appropriate Jun 2022-Apr 2023: Senior Project Manager - WEP Clinical, Little Rock (remote)

Oversaw and managed regional and global Managed Access Programs (MAPs)

Ensured all MAP project plans, timelines, and budgets, were developed, maintained, and in compliance with the SOW

Ensured project team’s leadership, training, and provide operational oversight

Ensured operational processes were maintained and projects were delivered within scope

Identified, evaluated, monitored, and mitigated any factors or processes that may threaten the quality of the project as well as communicate identified risks to internal team members, upper-level management, and clients, as appropriate

Developed, identified, and documented study-specific training requirements to assure project-level compliance

Prepared and finalized MAP out-of-scopes (OOS); Ensured Project Teams identify OOS effectively and developed the effective change orders in collaboration with Business Development

Ensured project teams manage MAPs in accordance with SOPs and Policies and met project timelines

Participated in proposal meetings for potential clients

Reviewed all documentation, including treatment guidelines, case report forms, and completion guidelines, informed consent documents, investigator agreements, Investigator Brochures, logic checks and data handling guidelines, and all other documents as required by the client

Developed, documented, and updated internal procedures and processes required for consistency across programs such as SOPs, working practices, and related QA forms

Oversaw delegation of support staff activities, as necessary

Ensured the compilation and completion of the eTMF and CTMS Aug 2020-Jul 2022: Regulatory Affairs Manager/Quality Assurance, Office of Research Regulatory Affairs

(ORRA) - UAMS, Little Rock

Supervised Regulatory Specialists and GTP Specialist in the ORRA Regulatory and Quality Units

Coordinated with ORRA Director and Monitoring Manager on all UAMS-sponsored INDs/IDEs

Oversaw cGMP IDP manufacturing and stability program with CMOs to synthesis drug substance, manufacture investigational drug product, perform release and stability testing on two novel vaccines, reported cGMP manufacturing and stability data to FDA

Performed QA/QC for investigator-initiated studies; Worked with outside QA Consultants as needed

Ensured compliance with GCP, GMP, GLP, and GTP for investigator-initiated novel products

Served as project manager for a multi-site, multi-study novel cancer vaccine project

Created, reviewed, edited, and revised IND CMCs and Investigator Brochures for novel products

Managed, created, edited, and revised all department Policies/SOPs

Applied 21 CFR 312 and §812 to investigator-initiated drug and device studies to determine IND/IDE requirements

Reviewed, edited, and revised clinical research protocols and consents in diverse fields of research

Prepared, submitted, and maintained regulatory documents required for IND/IDE submission to FDA

Served as ClinicalTrials.gov Administrator for UAMS; Managed the other ClinicalTrials.gov admins

Tracked IND projects including protocol and consent modifications, SAE, and annual progress reports Jul 2018-Jul 2020: Regulatory Specialist III/QA, Office of Research Regulatory Affairs - UAMS, Little Rock

Acted as Interim Regulatory Affairs Manager since April 2020

Acted as Interim Quality Assurance (QA) since January 2018

Oversaw cGMP IDP manufacturing and stability program with CMOs to synthesis drug substance, manufacture investigational drug product, perform release and stability testing on two novel vaccines, reported cGMP manufacturing and stability data to FDA

Performed QA/QC for investigator-initiated studies; Worked with outside QA Consultants as needed

Ensured compliance with GCP, GMP, and GTP for investigator-initiated novel products

Created, reviewed, edited, and revised IND CMCs and Investigator Brochures for novel products

Served as project manager for a multi-site, multi-study novel cancer vaccine project

Managed, created, edited, and revised all department Policies/SOPs

Applied 21 CFR 312 and §812 to investigator-initiated drug and device studies to determine IND/IDE requirements

Reviewed, edited, and revised clinical research protocols and consents in diverse fields of research

Prepared, submitted, and maintained regulatory documents required for IND/IDE submission to FDA

Tracked IND projects including protocol and consent modifications, SAE, and annual progress reports

Organized and attended local meetings and FDA conference calls; Took and circulated minutes Sep 2016-Jun 2018: Regulatory Specialist II, Office of Research Regulatory Affairs - UAMS, Little Rock

Acted as Interim Quality Assurance (QA) since January 2018

Reviewed, edited, and revised IND CMC sections and Investigator Brochures for novel products

Created, edited, and revised regulatory unit policies and procedures and department Policies/SOPs

Applied 21 CFR 312 and §812 to investigator-initiated drug and device studies to determine IND/IDE requirements

Reviewed, edited, and revised clinical research protocols and consents in diverse fields of research

Served a project manager for a multi-site, multi-study novel vaccine project

Prepared, submitted, and maintained regulatory documents required for IND/IDE submission to FDA

Tracked IND projects including protocol and consent modifications, SAE, and annual progress reports

Organized and attended local meetings and FDA conference calls; Took and circulated minutes Sep 2012-Sep 2016: Regulatory Specialist I, Office of Research Regulatory Affairs - UAMS, Little Rock

Applied 21 CFR 312 and §812 to investigator-initiated drug and device studies to determine IND/IDE requirements

Prepared, submitted, and maintained regulatory documents required for IND/IDE submission to FDA

Created, edited, and revised regulatory unit policies and procedures and department Policies/SOPs

Reviewed, edited, and revised clinical protocols and consents in diverse fields of research

Worked with investigators to collect appropriate data and updates in accordance with FDA regulations

Tracked IND projects including protocol and consent modifications, SAE, and annual progress reports

Organized and attended local meetings and FDA conference calls; Took and circulated minutes Sep 2011-Dec 2012: Research Assistant, College of Nursing - UAMS, Little Rock

Acted as Temporary Research Assistant on second project from May 2012-August 2012

• Assisted principal investigator in preparing study prior to project manager’s arrival

Screened, recruited, scheduled, and followed-up eligible patients; Transcribed interviews verbatim

Interviewed patients about symptoms, depression, and spirituality

Prepared, collected, and entered study data; Created, prepared, reviewed, and archived study related documents

Maintained regulatory binder; Prepared monthly petty cash reports May 2010-May 2011: Equipment Systems Specialist I, American Red Cross, Little Rock

Maintained computerized maintenance management system; Served as subject matter expert

Initiated and distributed corrective and preventive maintenance work orders, tracked all work orders

Oversaw approval process of new and existing equipment; Maintained equipment files and archives

Generated, distributed, reconciled, and analyzed reports; Assisted in developing management reports Jan 2010-Apr 2010: Unit Secretary, Arkansas Children’s Hospital, Little Rock

Maintained patient chart/record, reviewed charts daily, prepared charts for Medical Records per ACH policy

Processed and flagged physician orders per ACH policy; Documented and transferred patient medical records

Ordered supplies, made appointments and service requests; transported orders between unit and other departments

Performed clerical and receptionist duties, answered telephone/call lights to screen, record, and route calls, responded to patient requests, ensured a proper level of forms, supplies, and equipment Jan 2009-Apr 2009: Clinical Trial Assistant, Premier Research SARL, Paris

Translated study related documents (protocols, regulatory documents, correspondences)

Served as main contact for all team members for receiving, transmitting, monitoring, and archiving study related documents (correspondence, reports, administrative and regulatory documents, minutes)

Organized and attended local meetings and international conference calls, took and circulated minutes

Assisted on co-monitoring visits with clinical research associates to facilitate the work on site and support the sites

Created, prepared, updated, reviewed, diffused, and archived any documents or tools necessary for the proper management of the projects in adhering to the SOPs Jun 2007-Dec 2008: Clinical Research Assistant, Édouard Herriot Hospital, Lyon

Maintained and updated the Hematology Department database, data mined for retrospective studies and other collaborative work in Multiple Myeloma and autologous transplants

Translated scientific & medical articles for publication; Edited English scientific & medical documents

Translated brochures explaining CML and its treatment to patients

Organized two Patient Information Days (2nd EBMT Patients & Family Day in Florence, Italy, 1st SFGM-TC HSC Transplanted Patients in Marseille, France) and post-EBMT evenings Jun 2006-Jun 2007: Bilingual Secretary, Association ARCHE, Édouard Herriot Hospital, Lyon

Prepared and organized the 33rd EBMT Congress (European Group for Blood and Marrow Transplantation) in collaboration with the international, national, and local committees for over 3,600 international attendees

Managed all communication and documentation in English

Elaborated and organized the 1st EBMT Patients & Family Day and post-EBMT evenings

Edited, translated, and dubbed the Patient & Family Day DVD in French and English

Recruited and managed student congress workers

Collaborated closely with Prof. Michallet, Congress President, and Dr. Nicolini, Scientific Chair

Spearheaded and coordinated the daily reclamation of unused, cold chain maintained, congress food for reallocation to local charitable organizations for direct redistribution to food insecure community Education:

2008 Master 2 Applied Cognitive Science, with honors, Université Lumière Lyon II, Lyon, Courses (2006-07) Internship, Édouard Herriot Hospital (2007-08)

Masters Thesis: Conséquences de la transition technologique en milieu hospitalier: le cas du nouvel outil de prescription informatisée dans un service d’hématologie spécialisé 2006 Master 1 Cognitive Science, with honors, Université Lumière Lyon II, Lyon, Internship at INRETS Masters Thesis: Restriction de l'automobilité et restriction du champ visuel utile chez les conducteurs seniors 2005 Licence (equivalent to Bachelor’s degree) Cognitive Science, Université Lumière Lyon II, Lyon 2000 Bachelor of Arts in French, cum laude, University of Central Arkansas, Arkansas, USA Honors Thesis: Phonological Aspects of Primary and Secondary Language Acquisition Professional Certifications:

2019 Regulatory Affairs Certification (RAC US), RAPS (Regulatory Affairs Professional Society) 2013 Certified Clinical Research Professional (CCRP), SoCRA (Society of Clinical Research Associates) Professional Memberships

Member of RAPS (Regulatory Affairs Professional Society) (September 2012-present)

Member of SOCRA (Society of Clinical Research Associates) (September 2012-present)

• Co-Chair of the Arkansas SOCRA Chapter (December 2015-May 2019)

• SOCRA Chapter Recognition Award - In appreciation for offering the most Continuing Education for Clinical Research Professionals - Co-Chair - 2015-2016

• SOCRA Chapter Recognition Award - In appreciation for offering the most Continuing Education for Clinical Research Professionals - Co-Chair - 2016-2017

Member of ASQ (American Society Quality) (January 2019-January 2022)

• Treasurer of ASQ Central Arkansas Section 1407 (January 2020-January 2022) Professional Presentations:

ClinicalTrials.gov (2021)

Medical Device Clinical Trial Regulations and GCP (2020)

Investigational New Drug Applications (INDs) (2013, 2016, 2018, 2021)

Expanded Access to Investigational Drugs (2015, 2017, 2020, 2021)

Orphan Drugs (2014, 2015)

Skills & Abilities:

Extensive knowledge of clinical research process from Phase I through regulatory submission

Extensive knowledge of current ICH GCP Guidelines

Working knowledge of ICH Quality Guidelines

Strong communication skills to express complex ideas

Excellent organizational and interpersonal skills

Ability to reason independently to assess and recommend specific solutions in clinical settings

Ability to interact with all levels of staff to coordinate and execute project activities

Ability to manage multiple priorities

Ability to set baseline targets, track trends, and implement mitigation plans

SharePoint power user, Adobe Pro DC, Access database manager, Advanced MS Word, Excel, PowerPoint skills, Data Entry (multiple databases), DSS Player Pro

Languages:

English: native French: fluent, quasi-bilingual Spanish: basic Swedish: notions Publications:

Ipe TS, Le T, Quinn B, Kellar S, Clark M, Carlisle S, Rassmann A, Hennigan S, Ridenour T, Roberts A, Avery D, Ryan S, Pearson S, Kothari A, Patil N. (2020). Provision of COVID-19 Convalescent Plasma in a Resource-Constrained State. Transfusion. doi: 10.1111/trf.16118. Epub ahead of print. PMID: 32989778; PMCID: PMC7536906.

Bobillier-Chaumon, M-E, & Clark, M. (2008). Conditions de l’Acceptation Technologique dans un Contexte de Transition Technologique : le Cas d’un Système de Prescription Médicale. Actes du congrès de l’Association Internationale de Psychologie du Travail de Langue Française, Montréal, Canada.

Bobillier-Chaumon, M-E, & Clark, M. (2008). Computerized Prescription System: Implication of a Technological System Shift on Intensive Care Units. Conference Proceedings of the International Conference of Healthcare Systems Ergonomics and Patient Safety: Creating and Designing the Healthcare Experience, Strasbourg, France.

Michallet M, Le Q, Raus, N, Sobh M, Revesz D, Thiébaut A, Thomas X, Chelgoum Y, Ducastelle S, Troncy J, Clark M, Nicolini F. (2007). Transplant-related mortality after allogeneic reduced-intensity conditioning haematopoietic stem cell transplantation: a study on influence of parameters before and after transplant. Conference Proceedings of the 33rd Annual Meeting of the European Group for Blood & Marrow Transplantation, Lyon, France.

Michallet M, Le Q, Raus, N, Sobh M, Revesz D, Thiébaut A, Thomas X, Chelgoum Y, Ducastelle S, Troncy J, Clark M, Nicolini F. (2007). Chronic graft-versus-host disease after allogeneic reduced-intensity haematopoietic stem cell transplantation. Conference Proceedings [Abstract] of the 33rd Annual Meeting of the European Group for Blood & Marrow Transplantation, Lyon, France.

Thiébaut A, Bréchard C, Noyel J, Petiot S, Saint-Sorny M, Chatain M, Clark M, Michallet M. (2007). JACIE accreditation in our centre 18 months later, what is new? Conference Proceedings [Abstract]of the 33rd Annual Meeting of the European Group for Blood & Marrow Transplantation, Lyon, France.

Plesa A, Le Q, Revesz D, Thomas X, Ducastelle S, Nicolini FE, Michallet AS, Mollet I, Dubois V, Clark M, Dumontet C, Raus N, Sobh M, Michallet M. (2008). Correlation between MRD and chimerism kinetics in CLL patients after myeloablative and non-myeloablative allogeneic haematopoïetic stem cell transplantations. Conference Proceedings [Abstract] of the 34th Annual Meeting of the European Group for Blood & Marrow Transplantation, Florence, Italy. Pedagogic Experience:

2002-2008: English Teacher

Université Lumière, Bron: 3rd year Cognitive Science students

ECAM, Université Catholique, Lyon: 1st year engineering students, TOEFL preparation

ESDES, Université Catholique, Lyon: 2nd year business students, ACCES oral entrance exam selection panel

ISARA, Université Catholique, Lyon: 3rd year agro-business students, Cambridge FCE preparation 2003-2004: English Instructor

TELAB: English lessons for professionals by phone, beginner to advanced 2000-2003: English Language Assistant, Éducation Nationale, France

Collège des Iris & Collège Jean Vilar, Villeurbanne

Collège Lacassagne & Lycée Hector Guimard, Lyon

Lycée Montdory, Thiers

Additional activities:

LRCPAAA (Little Rock Citizens Police Academy Alumni Association) (2016-present)

Member of Francophone/Francophile Group, Little Rock (2014-present)

Co-organizer of the J’aime Parler Français group, Little Rock (2014-2020)

Independent Translator and private tutor for adolescents and adults in Lyon, France (2001-2009)

Technical Translator, Kelly Services, Lyon, France (2004)

President of the Cercle Français, University of Central Arkansas in Conway, AR, USA (1999-2000)

Contact this candidate