Data Entry Clinical Research

L O U I S E M A L L O N

S E N I O R G L O B A L P R O J E C T M A N A G E R

R I VERVIEW, FL

813-***-**** ************@*****.***

P R O F E S S I O N A L S U M M A R Y

Clinical research professional with over 20 years of experience managing Phase I–IV drug and device trials. Expertise spans CROs and pharma, global operations leadership, study tool implementation, regulatory compliance, and client portfolio oversight. Strong knowledge of FDA, GCP, ICH, and development processes. While I don’t hold a bachelor’s degree, I have earned an associate degree and bring years of hands-on experience in clinical research, with a proven track record of delivering results in within budget, timelines and client satisfaction. T H E R A P E U T I C A R E A E X P E R T I S E

Al amyloidosis (Phase II)

Multiple myeloma (Phase III)

Crohn’s disease (Phase II and III)

Ulcerative colitis (Phase III)

Osteoarthritis of the knee (Phase III)

Acute otitis externa (Phase III)

Infertility (Phase I–IV and FU)

Bowel preparation for colonoscopy (Phase III)

Infertility (device) (Phase III)

Primary hypothalamic amenorrhea (Phase III)

Osteoarthritis of the knee (Phase III)

Osteoarthritis of the thumb (Phase II)

HIV AIDS infection (observational and non-interventional) S K I L L S

GCP Compliance – Ensuring adherence to good clinical practice guidelines.

Project Management – Proficiency in managing clinical trials with oversight of cross-functional teams.

Risk Management – Skills in identifying and managing risks associated with clinical trials.

Data Management – Ability to manage and analyze data accurately and efficiently.

Communication – Strong verbal and written communication skills.

Leadership – Experience in leading and managing clinical research teams and projects.

Problem-Solving – Skilled at identifying issues, analyzing root causes, and implementing effective solutions.

Ability to lead – Proven ability to lead by example, motivate teams, and drive performance.

Ethical - Committed to maintaining integrity, honesty, and accountability in all aspects of work. D A T A B A S E E X P E R I E N C E

Microsoft Word, Excel, PowerPoint SharePoint; Medidata Rave, IWRS and IVRS, Oracle, Kofax, Procurement, Workday, PMED, PMEX, vTMF Vault, Impact Harmony, MyTrials, MAP, SitePay, Precision, Planisware, Salesforce, Business Intelligence Reports

P R O F E S S I O N A L E X P E R I E N C E

PAREXEL INTERNATIONAL, Riverview, FL 07/2018 – 05/2025 Project Leader (04/2022 – 05/2025) (Decentralized) Managed and oversaw all elements of clinical trials to ensure project deliverables and client satisfaction were executed to the highest standards.

I actively led cross-functional and client teams by leveraging my extensive clinical research experience, serving as the primary point of contact for internal teams, clients, and vendors. This role involved providing clear, consistent communication and proactive problem-solving to ensure smooth project progression. I oversaw all phases of clinical studies, including study start-up, maintenance, and close-out, as well as site management, monitoring activities, LOUISE MALLON PAGE 2

logistics, safety, quality assurance, and data management. Throughout these processes, I effectively addressed and resolved challenges related to timelines, budgets, and resource allocation, ensuring projects stayed on track. Additionally, I ensured strict adherence to regulatory requirements, Good Clinical Practice (GCP) guidelines, standard operating procedures (SOPs), and project-specific protocols, maintaining the highest standards of compliance and quality.

Senior Clinical Operations Leader (04/2021 – 04/2022) (Decentralized) Led coordination between functional teams, project management, and sponsors to meet clinical deliverables. Accountable for project execution, tool development, financial tracking, and process improvements. Fostered collaboration, prioritized key issues, and ensured clear communication with global teams and stakeholders. Led monitoring-related project activities, including study tool preparation, report review, budget oversight, and deliverable tracking. Collaborated with clinical teams, vendors, and investigators to ensure data quality. Managed client communication and provided mentoring and training to clinical research associates. Primary contact for the clinical research associate team, clinical operation leads, clients and vendors for study related updates, issues, and questions.

Clinical Operations Leader (07/2018 – 04/2021) (Decentralized) Joined Parexel 07/16/2018.

Led global teams to meet clinical goals, managed tools and finances, and served as primary contact for CRAs, operations leads, clients, and vendors.

DSP CLINICAL RESEARCH, LLC, Multiple Locations 06/2007 – 07/2018 Manager, Clinical Operations, Riverview, FL (Decentralized) Managed global clinical trials, liaised with stakeholders, led teams, ensured compliance, and oversaw project execution and site evaluations.

Senior Clinical Operations Lead, Riverview, FL (01/2013 – 12/2016) (Decentralized) Managed clinical monitoring, data quality, and vendor oversight for global trials, liaised with sponsors, led monitoring teams, developed trial documentation, ensured protocol compliance, and supported site evaluations and monitoring visits.

Clinical Operations Lead, Riverview, FL (01/2011 – 12/2012) (Decentralized) Communicated with sponsors and clients, managed clinical monitoring, data quality, and vendor oversight for global projects per SOPs, ICH, and GCP.

Project Coordinator, Tampa, FL (12/2009 – 12/2010) (Decentralized) Project Coordinator, Parsippany, NJ (06/2009 – 12/2009) Oversaw field monitors’ visit schedules to ensure alignment with the monitoring plan, reviewed and approved trip reports for timely completion per SOPs, and collaborated with the data manager to track data metrics and ensure consistent monitoring and source data verification. Clinical Research Associate, Parsippany, NJ (06/2007 – 06/2009) Provided overall site management ensuring regulatory compliance, verification of data accuracy and quality, oversaw investigational product handling, maintained good relationship and communication with study sites and sponsors, documented and reported site activities and issues and identified and supported sites with protocol deviations and risks. QUINTILES, INC., Parsippany, NJ 04/2007 – 06/2007

Senior Clinical Assistant

Provided centralized support to the clinical project team by independently managing data entry in clinical tracking systems and handling the preparation, management, and distribution of clinical documentation for designated activities. LOUISE MALLON PAGE 3

FERRING PHARMACEUTICALS, INC., Suffern, NY 04/2005 – 04/2007 Clinical Assistant

Managed end-to-end Phase I–III study operations, including SAE tracking, vendor and site payments, regulatory documentation, and trial master file maintenance.

E D U C A T I O N

Associate of Science (AS), Health Administration Services, COLORADO TECHNICAL UNIVERSITY, Colorado Springs, CO (ONLINE) C E R T I F I C A T I O N S

HIPAA Certified, COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI) Good Clinical Practice, COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI) Protection of Human Subjects, COLLABORATIVE INSTITUTIONAL TRAINING INITIATIVE (CITI) Clinical Investigators and the FDA Inspectional Process, NORTON AUDITS, INC. Fundamentals of Clinical Research Monitoring, DRUG INFORMATION ASSOCIATION (DIA) P R O F E S S I O N A L A S S O C I A T I O N S

Member, ASSOCIATION OF CLINICAL RESEARCH PROFESSIONALS Member, DRUG INFORMATION ASSOCIATION

L A N G U A G E S K I L L S

English – Native speaker

Spanish – Native speaker

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