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CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.

Could you be our next Senior TMF Lead? The job is in our King of Prussia PA, Waltham MA, Maidenhead UK or Zurich Switzerland office. This is a hybrid position and is onsite three days a week. You will report to the Senior Director, Head of Clinical Compliance & Specialty Ops.

You will play a pivotal role in the strategic and operational execution of clinical trials by overseeing the Trial Master File (TMF) lifecycle. This role is accountable for developing and implementing operational strategies that ensure inspection readiness, regulatory compliance, and high-quality documentation across clinical programs. Operating within a matrixed environment, the Senior TMF Lead collaborates with internal teams and external partners to drive study efficiency, manage vendors, and support continuous improvement in TMF processes.

TMF Oversight

Design and implement operational strategies and study management plans that support TMF completeness, quality, and compliance

Inspection Readiness & Quality Assurance

Lead periodic completeness reviews and quality checks of TMF content. Ensure documents meet Good Documentation Practice (GDP), Good Clinical Practice (GCP), and ICH standards. Identify gaps and drive remediation efforts.

Cross-Functional Collaboration & Vendor Management

Coordinate with clinical trial teams, CROs, and eTMF vendors throughout trial start-up, maintenance, and close-out. Facilitate communication and training on TMF processes and expectations.

Process Improvement & System Optimization

Continuously assess TMF processes and systems for improvement opportunities. Support the implementation of new tools and workflows that enhance operational efficiency and data integrity.

Risk Management & Compliance Monitoring

Conduct risk assessments related to TMF documentation and escalate non-compliance issues. Track and report progress on quality issue resolution and ensure the TMF remains inspection-ready at all times.

Act as the primary point of contact both internally and externally (e.g., vendors) as applicable for anything study related.

Maintain up to date knowledge of the therapeutic area/product candidate(s), clinical practice, competitors, and regulatory considerations.

Support audits/inspections and resolutions of findings.

Support in the development of new SOPs, guidelines etc and/ or participate in working groups about new processes.

QUALIFICATIONS:

B** **achelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred

As a guide, a minimum of 7 years’ relevant clinical research (or related) experience within the pharmaceutical industry.

Previous experience in leading and managing a team of professional staff.

A solid understanding of the drug development process, and specifically, each step within the clinical trial process.

Experience in overseeing large and/or complex global clinical trials.

Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process

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Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site (https://www.cslbenefits.com/csl/candidates) to see what’s available to you as a CSL employee.

About CSL Behring

CSL Behring (http://cslbehring.com/) is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma (http://www.cslplasma.com) . Our parent company, CSL (https://www.csl.com/) , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

We want CSL to reflect the world around us

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL (https://www.csl.com/careers/inclusion-and-belonging) .

Do work that matters at CSL Behring!

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CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement