2 дня назад
Senior Clinical Trial Associate
86 000 - 105 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Clinical Trial Associate (Clinical Operations): Supporting the planning, execution, oversight, and closeout of global clinical trials with an accent on study documentation, operational tracking, CRO and vendor coordination, and inspection readiness. Focus on maintaining TMF quality, tracking study milestones and enrollment, resolving operational risks, and establishing scalable clinical operations processes.
Location: Waltham, MA, United States; onsite
Salary: $86,000–$105,000 USD annually
Company
develops therapeutics targeting muscle and the central nervous system to improve outcomes for people living with genetically driven neuromuscular diseases.
What you will do
- Support Clinical Study Leads and cross-functional teams throughout feasibility, planning, start-up, enrollment, maintenance, and closeout of global clinical trials.
- Coordinate communication with CROs, vendors, investigative sites, and internal stakeholders while identifying risks and resolving operational issues.
- Track study metrics, milestones, site activation, enrollment, vendor deliverables, and sponsor oversight activities.
- Coordinate, review, route, distribute, and maintain essential study documents and operational materials.
- Prepare meeting agendas, materials, minutes, decision logs, and action-item trackers for internal and external meetings.
- Maintain the trial master file, perform routine reviews, close documentation gaps, and support inspection readiness.
Requirements
- Bachelor’s degree in life sciences, healthcare, or a related field preferred, or an equivalent combination of education and experience.
- At least 3 years of hands-on clinical operations or drug development experience, preferably in a sponsor setting and with global or multisite trials.
- Working knowledge of clinical trial operations, ICH-GCP guidelines, regulatory requirements, TMF expectations, and inspection readiness.
- Experience collaborating with Clinical Operations, Clinical Development, Regulatory Affairs, Quality Assurance, Data Management, Biostatistics, Medical Writing, Clinical Supply, Finance, and external vendors.
- Proficiency with clinical trial tracking systems, document management tools, Microsoft Office, and related trial execution systems.
- Willingness to travel for investigator meetings, site visits, conferences, or vendor meetings; expected travel is approximately 5%.
Culture & Benefits
- Work in a patient-focused clinical development environment.
- Collaborate across cross-functional study teams and external partners.
- Contribute to process standardization, operational efficiency, quality, and continuous improvement.
- Operate in an environment emphasizing professionalism, integrity, accountability, and sound judgment.
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