This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Associate II, TMF Operations based in United Kingdom.
This is an opportunity to join a global clinical research environment where your expertise helps ensure the accuracy, compliance, and quality of essential trial documentation.
You will play a key role in managing Trial Master Files (TMFs), supporting regulatory standards, and enabling successful clinical research outcomes.
The position combines operational ownership, quality management, stakeholder collaboration, and regulatory expertise.
You will work closely with project teams and sponsors, providing guidance and ensuring documentation processes meet industry expectations.
This role offers the chance to contribute to meaningful healthcare advancements while working within a collaborative international team.
You will have the opportunity to influence best practices, improve processes, and support high-quality clinical trial delivery.
The ideal candidate is detail-oriented, organized, and passionate about maintaining excellence in a highly regulated environment.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Associate II, TMF Operations based in United Kingdom.
This is an opportunity to join a global clinical research environment where your expertise helps ensure the accuracy, compliance, and quality of essential trial documentation.
You will play a key role in managing Trial Master Files (TMFs), supporting regulatory standards, and enabling successful clinical research outcomes.
The position combines operational ownership, quality management, stakeholder collaboration, and regulatory expertise.
You will work closely with project teams and sponsors, providing guidance and ensuring documentation processes meet industry expectations.
This role offers the chance to contribute to meaningful healthcare advancements while working within a collaborative international team.
You will have the opportunity to influence best practices, improve processes, and support high-quality clinical trial delivery.
The ideal candidate is detail-oriented, organized, and passionate about maintaining excellence in a highly regulated environment.
Accountabilities:
- Manage TMF operations activities for multiple complex studies or sponsor portfolios.
- Collaborate directly with project teams and sponsors to assess TMF requirements and provide subject matter expertise.
- Oversee Trial Master File quality control processes, including planning, tracking, reporting, and follow-up on compliance issues.
- Support the creation and maintenance of project-specific TMF quality management documentation.
- Prepare, maintain, and present TMF key performance indicators and data analysis trends.
- Identify documentation risks and recommend solutions that align with regulatory requirements and industry standards.
- Support regulatory inspections, sponsor audits, and resolution of audit findings when required.
- Partner with cross-functional teams to improve TMF processes and maintain operational excellence.
- Ensure all records management activities follow applicable procedures, regulations, and best practices.
- University degree preferred, ideally in Life Sciences or a related field.
- 2-4 years of relevant experience through a combination of education and professional experience.
- Experience working within a highly regulated industry, CRO, pharmaceutical, or clinical research environment.
- Strong understanding of clinical research principles, industry standards, and TMF management requirements.
- Strong planning and organizational skills with the ability to manage deadlines and competing priorities.
- Excellent written and verbal communication skills, with the ability to present information clearly to internal and external stakeholders.
- Strong interpersonal skills and the ability to collaborate effectively in a fast-paced, changing environment.
- Ability to identify problems, evaluate options, and recommend compliant solutions.
- Strong attention to detail and commitment to maintaining high-quality documentation standards.
- Opportunity to contribute to clinical research projects that improve patients’ lives worldwide.
- Work within a global and collaborative team environment.
- Exposure to international clinical research operations and industry best practices.
- Opportunity to develop expertise in TMF management and regulatory compliance.
- Supportive workplace culture focused on inclusion, collaboration, and professional growth.
- Opportunities to work with experienced professionals across different functions and regions.
- Chance to build a meaningful career within a purpose-driven healthcare organization.
- Inclusive environment where diverse perspectives and experiences are valued.
You will be responsible for overseeing TMF operations activities across complex studies or sponsor portfolios, ensuring documentation quality, compliance, and operational efficiency. You will act as a subject matter expert while collaborating with internal teams and external stakeholders to support successful clinical trial execution.
Requirements:
The ideal candidate has experience working within clinical research, pharmaceutical, or other highly regulated environments, with strong organizational skills and the ability to manage multiple priorities. You should be comfortable collaborating with global stakeholders and ensuring compliance in complex projects.