Magdalena Cruces Melgarejo
Santiago
Summary
I've been happy and grateful to perform different roles in my life. Apart from being an independent woman, daughter, sister and an aunt, I think that being an English Teacher, for 14 years, is one of the most important. Working in the education field with students from primary, secondary and adults definitely changed the way I see life. Currently, I am working as a Country Approval Specialist at PPD, part of Thermofisher, where I've developed as Site Activation Coordinator, facilities Assistant and Feasibility coordinator. I believe in excellence. That is why, I always do my best to achieve all the goals I've been assigned. My skills are varied from having proficiency in English-Spanish Translation, Teamwork, Problem Solving, multitasking, proactivity to being emphatic. I love my job, which has allowed me to travel and see the world with its many beautiful places and people.
Overview
21
21
years of professional experience
Work History
Country Approval Associate
Thermo Fisher Scientific
08.2023 - Current
- Company Overview: I'm proud to be part of Thermo Fisher Scientific, a company that values diversity, inclusion, and meaningful innovation. Here, my work contributes to making the world healthier, cleaner, and safer.
- As a Country Approval Specialist, I'm responsible for managing and coordinating Ethics and regulatory approval processes for global clinical trials in Chile. This includes submitting applications to Ethics Comittees and regulatory authorities, collaborating with investigator sites, and ensuring all activities comply with local, national, and international regulations.
- I work closely with clinical research associates, trial managers, regulatory teams, and other cross-functional partners to streamline study startup processes and meet project timelines. I'm also in charge of preparing and submitting essential documentation, maintaining accurate records, and assembling activation packs for site approval.
- To succeed in this role, I draw on my experience in clinical operations or regulatory affairs, along with a strong understanding of Indian regulations and GCP guidelines. My strengths include attention to detail, clear communication, and a collaborative mindset.
- I'm proud to be part of Thermo Fisher Scientific, a company that values diversity, inclusion, and meaningful innovation. Here, my work contributes to making the world healthier, cleaner, and safer.
Clinical Trial Coordinator
PPD
05.2022 - 07.2023
- I have brought a wealth of knowledge and skills in clinical trial coordination. My proficiency in English-Spanish translation, teamwork, and problem-solving has enabled me to support the Start-Up Team effectively. I have also gained valuable experience in administrative and technical support, audit readiness, and file reviews, which are crucial for this role. My dedication to excellence and proactivity ensures that I always strive to achieve the goals assigned to me.
I have Provided administrative and technical support to the Start Up Team, supporting audit readiness by ensuring files are reviewed on schedule detailed in the organization, performing internal File Reviews and ensuring allocated task are performed on time, among others.
Site Activation Coordinator
PPD
10.2020 - 05.2022
- I supported the Start Up Team as a coordinator.
Facilities Assistant
PPD
11.2018 - 10.2020
- I supported the smooth operation and maintenance of the office, based in Chile, handling a variety of tasks related to both maintenance and administrative duties. I had to ensure the physical workspace is well-maintained, safe, and functional for occupants.
- I also supported the Finance Team and reception.
Temporary Jobs
Quiñenco S.A.
07.2017 - 09.2017
- Answering the telephone and taking messages or forwarding calls, scheduling and confirming appointments, and maintaining calendars. Greeting customers, clients, and other visitors, among others.
Internship Program
HSBC
03.2017 - 06.2017
- Proficient in two languages, English and Spanish, supporting communication and tasks between both languages, translating, providing customer support, and assisting with administrative duties.
English Teacher
03.2004 - 03.2017
- I worked as an English teacher in different schools, teaching children, teenagers and adults for 13 years, developing new strategies to involve students in this second language. I used different methodology to teach my students and develop the four skills of the foreign language, learning English is not just about grammar, but about developing tools for them to survive in a country, where English is not commonly used.
- I preferred working with vulnerable students with lack of basic skills and affection.
Education
Bilingual Executive Assistant - Business Administration and Management, General
Centro de Formación Técnica Manpower
01.2018
Teacher of English -
Pontificia Universidad Católica de Chile
01.2004
English - Spanish Translator - business -legal -Technical- Social
Universidad Católica de Temuco
12.2000
Skills
- Multitasking
- Proactive
- Problem Solving
- Spanish Translation
- Teamwork
- Empathy
- Caring
- Social skill
- Leadership
Languages
Spanish
Native or Bilingual
English
Full Professional
Timeline
Country Approval Associate
Thermo Fisher Scientific
08.2023 - Current
Clinical Trial Coordinator
PPD
05.2022 - 07.2023
Site Activation Coordinator
PPD
10.2020 - 05.2022
Facilities Assistant
PPD
11.2018 - 10.2020
Temporary Jobs
Quiñenco S.A.
07.2017 - 09.2017
Internship Program
HSBC
03.2017 - 06.2017
English Teacher
03.2004 - 03.2017
Teacher of English -
Pontificia Universidad Católica de Chile
English - Spanish Translator - business -legal -Technical- Social
Universidad Católica de Temuco
Bilingual Executive Assistant - Business Administration and Management, General
Centro de Formación Técnica Manpower
Similar Profiles
Emily RobinsonEmily Robinson
Pharmacy Technician II at Fisher Bioservices, Thermo Fisher ScientificPharmacy Technician II at Fisher Bioservices, Thermo Fisher Scientific
Raj KiranRaj Kiran
Senior HRIS Specialist at Thermo Fisher Scientific Inc.Senior HRIS Specialist at Thermo Fisher Scientific Inc.
Rodney CrowderRodney Crowder
Senior Field Service Supervisor at Thermo Fisher Scientific Inc.Senior Field Service Supervisor at Thermo Fisher Scientific Inc.
NEHA SALUNEHA SALU
Scientist at Thermo Fisher Scientific Inc.Scientist at Thermo Fisher Scientific Inc.
Natalia Peña DíazNatalia Peña Díaz
Instructor Asistente En Bootcamp Python at SkillnestInstructor Asistente En Bootcamp Python at Skillnest