Senior Associate I, TMF Operations
New
J
JobgetherClinical Research
BrazilContractSenior
Salary not disclosed
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Job Details
- Experience
- 1–3 years
- Required Skills
- Project ManagementData Analysis
Requirements
- University degree preferred, ideally in Life Sciences or a related discipline.
- 1–3 years of relevant experience in clinical research, pharmaceutical, CRO, or another highly regulated industry.
- Strong understanding of clinical research principles, TMF management practices, industry standards, and regulatory requirements.
- Excellent planning, organizational, and prioritization skills with the ability to manage multiple projects under pressure.
- Strong written and verbal communication skills, with the ability to clearly present information to internal and external stakeholders.
- Ability to analyze situations, identify solutions, and make informed decisions while maintaining regulatory compliance.
- Strong interpersonal skills and ability to collaborate effectively in a global, fast-paced environment.
- Ability to work independently and demonstrate increasing levels of responsibility and ownership.
- Experience supporting audits, quality reviews, or compliance activities is highly valued.
Responsibilities
- Perform TMF operational activities across multiple complex clinical studies or sponsor portfolios.
- Collaborate directly with project teams and sponsors to assess documentation needs and provide subject matter expertise on TMF processes.
- Manage and support quality control activities, including planning, reporting, tracking, and follow-up of compliance issues.
- Assist in the creation and maintenance of study-specific TMF quality management documentation.
- Prepare, maintain, and present TMF key performance indicators (KPIs) and data analysis trends to project teams and sponsors.
- Support regulatory inspections, sponsor audits, and resolution of audit findings when required.
- Ensure documentation practices align with applicable regulations, standard operating procedures, and industry best practices.
- Identify operational challenges and recommend compliant solutions for complex documentation and process-related situations.
- Contribute to continuous improvement initiatives within records management and clinical operations processes.
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