Opportunity to translate global regulatory strategies into meaningful, executable submission plans, applying your project management expertise to assist us in driving our pipeline of rare disease programs into the hands of patients.
Job Detail
Job Description
Responsibilities:
- Overseeing the planning, implementation, and management of clinical trials, ensuring that they are conducted in compliance with regulatory and ethical guidelines
- Developing study protocols, case report forms, and other study-related documents in collaboration with cross-functional teams
- Identifying and managing vendors, including contract research organizations (CROs), clinical laboratories, and other service providers
- Monitoring study progress, including patient enrollment, data collection, and analysis
- Ensuring timely data entry and query resolution, and managing data cleaning and database lock activities
- Managing study budgets and timelines, and ensuring that study costs are within budget
- Maintaining strong relationships with key stakeholders, including investigators, study coordinators, and regulatory authorities
- Participating in the preparation of regulatory submissions and inspections
- Providing guidance and mentorship to clinical operations staff as needed
Requirements:
- Bachelor's or advanced degree in a life sciences field
- Minimum of [insert number of years] years of experience in clinical trial management or related field
- Knowledge of ICH-GCP guidelines and other regulatory requirements for clinical trials
- Strong project management skills, including the ability to manage timelines, budgets, and resources effectively
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external stakeholders
- Strong analytical skills, with the ability to analyze complex data sets and draw insights
- Ability to work independently and take initiative to resolve issues and ensure timely study execution
Required skills
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