Project Management Start-Up

Marcella Coelho

Contact: ************@*****.*** Phone: +1-551-***-****

WORK EXPERIENCE

COGENTECH, Remote September 2023 - Present

Analyst Clinical Site Management

• Proactively track essential documents to ensure compliance throughout the study lifecycle.

• Manage the archiving of clinical documents, including the maintenance of the electronic Trial Master File (TMF), to facilitate easy access and regulatory readiness.

• Regularly update tracking systems to reflect current data, ensuring accurate reporting and analysis of study progress.

• Collaborate closely with Clinical Project Managers on effective regulatory document management, fostering communication and coordination to meet start-up deadlines.

• Oversee correspondence with document vendors to ensure timely and accurate delivery of documentation services.

• Assist Regulatory Affairs in the preparation and submission of dossier packages, contributing to well-organized and comprehensive documentation.

• Perform IRB submissions for central sites.

• Support Project Management by ensuring timely delivery of key Data Management deliverables, including plans, screening slides, image upload guidelines, eCRF guidelines, committee charters, etc, to optimize the study start-up phase.

• Track and update site start-up documentation, including submission and informed consent form

(ICF) trackers, to ensure the accuracy and completeness of information per site.

• Oversee site qualification, initiation, monitoring, management, and close-out documentation, ensuring compliance with regulatory requirements, ICH-GCP guidelines, and study protocols while escalating critical issues and contributing to actionable plans.

• Perform IRB Protocol level CRRF for general study.

• Perform IRB site closure submissions for central sites. COGENTECH, Remote January 2023 - September 2023

Junior Clinical Project Assistant

• Managed TMF filing, maintaining accuracy and compliance.

• Printed physical binders for sites and updated electronic regulatory binders, site contact lists, and team contact lists for applicable sites in liaison with external Site Managers.

• Tracked and kept up-to-date site start-up, submission, and ICF trackers, ensuring all information remained accurate.

• Provided accurate information for regulatory checklists before site activation.

• Received and reviewed documentation thoroughly to ensure accurate completion of all study logs prior to filing in the TMF. Identified discrepancies and collaborated with team members to request necessary corrections in accordance with GCP standards, actively maintaining data integrity and compliance throughout the study.

• Drafted Notes to File (NTF) for necessary clarifications. COGENTECH, Remote April 2020 - January 2023

Administrative Assistant

• Managed daily organizational activities, optimizing communication and operational efficiency across departments.

• Supervised scheduling, document proofreading, and maintaining information management systems for accuracy and efficiency.

Marcella Coelho

STAY HOME MOM December 1997 – April 2020

Manager

• Successfully managed a household as a stay-at-home mom from 1997 to 2020, balancing the responsibilities of raising five children, all of whom have pursued and obtained college degrees. Actively volunteered during this time to maintain and enhance my skills.

CLINICAL TRIALS THERAPEUTIC EXPERIENCE

Cardiovascular

Phase IV

8 countries (USA, Colombia, Mexico, Brazil, India, Spain, Italy, Poland, Panama). 3450 enrolled patients.

Endovascular Medical

Device

First in Man

1 Country USA

44 sites activated. 130 patients enrolled.

Endovascular Medical Device

First in Man

3 Countries (Italy, Canada and Austria)

7 sites. 45 patients enrolled.

Oncology Medical Device

First in Man

1 country: Colombia. 2 sites, 15 patients enrolled Skills

Computer Literacy, Good Clinical Practice, ICH, Interpersonal Skills, Organizational Skills, Skilled Multi-tasker, Spreadsheets, Vendor Management, Written Communication. SOFTWARE EXPERIENCE

Microsoft applications, Smartsheet, Signature Platforms, Veeva, Real-Time CERTIFICATIONS

GCP Certificate exp 07/03/2026

Cybersecurity Awareness Training 2022

EDUCATION

University ICESI, Cali, Colombia

B.A. Business Management, December 1996

Technical Degree Graphic Design, 1995

LANGUAGES

English — Fluent, native speaker

Portuguese — Fluent, native speaker

Spanish — Fluent, native speaker

French — Conversational

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