Maria Sterling
@mariasterling
Clinical research professional dedicated to improving patient quality of life.
What I'm looking for
I am a clinical research professional with over 6 years of experience in both site-level and sponsor-level clinical research. My work has been driven by a deep understanding of the challenges in translating research advances into clinical practice and novel treatments. I am dedicated to improving patients' quality of life through my contributions in clinical research.
Throughout my career, I have developed expertise in managing electronic Trial Master Files (eTMF), overseeing clinical supply, and locking multiple databases concurrently. My organizational, problem-solving, and communication skills have allowed me to collaborate effectively across various functions, including Data Management, Quality Assurance, and Regulatory Affairs. I am proficient in both English and Spanish, which enhances my ability to work in diverse environments.
In my most recent role as a Clinical Operations Manager, I successfully managed day-to-day clinical trial operations, led cross-functional teams, and developed risk management plans to address potential study challenges. I am passionate about ensuring compliance and operational excellence in clinical trials, and I continuously seek to apply lessons learned across studies to improve processes.
Experience
Work history, roles, and key accomplishments
Clinical Consultant
Neuren Pharmaceuticals Limited
Nov 2023 - Oct 2024 (11 months)
Assisted in the early termination and closeout of a clinical study by coordinating with study sites, preparing necessary documentation, and ensuring compliance with regulatory requirements. Supported the development and implementation of risk management plans and mitigation strategies for potential study challenges.
Clinical Operations Manager
Anavex Life Sciences Corp.
Jan 2022 - Nov 2023 (1 year 10 months)
Managed and supported day-to-day clinical trial operations by overseeing various study vendors, study-specific management plans, protocol compliance, and site monitoring activities. Led the operational effort in database lock for multiple studies concurrently, ensuring on-time delivery of top-line data.
Clinical Operations Associate
Anavex Life Sciences Corp.
Oct 2019 - Dec 2022 (3 years 2 months)
Performed IP reconciliation and accountability at study closeout for multiple studies. Managed the allocation of clinical product formulation campaigns across various clinical trials, coordinating with cross-functional teams to determine product demand.
Clinical Research Assistant
Joslin Diabetes Center
Jan 2019 - Oct 2019 (9 months)
Scheduled and prepared patient study visits in accordance with the study protocol, including preparing lab kits and required visit documents. Ensured participant safety by documenting and submitting adverse events, serious adverse events, and protocol deviation forms within regulatory timelines.
Cardiology Research Intern
Boston Children's Hospital
Mar 2017 - Dec 2017 (9 months)
Responsible for the feeding and caring of laboratory animals used in experimental research. Documented and reported changes in animal behavior and feeding habits with meticulous attention to detail.
Neurology Clinic Volunteer
Boston Children's Hospital
Sep 2015 - Feb 2017 (1 year 5 months)
Interacted with pediatric patients and their families at bedside in the neurology department. Organized and maintained a safe, clean environment for patients and families in the department's playroom.
Education
Degrees, certifications, and relevant coursework
Emmanuel College
Bachelor of Science, Biology with a Concentration in Health Sciences
Graduated with a Bachelor of Science in Biology with a concentration in Health Sciences. Also completed a minor in Psychology, providing a comprehensive understanding of biological and psychological principles.
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
Job categories
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