CSL
Overview
CSL's R&D organization is accelerating innovation to deliver greater impact for patients. Joining CSL means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. This is a hybrid Senior TMF Lead role located in King of Prussia, PA; Waltham, MA; Maidenhead, UK; or Zürich, Switzerland. The position is onsite three days a week and reports to the Senior Director, Head of Clinical Compliance & Specialty Ops. Senior TMF Lead – Responsibilities
Oversee the Trial Master File (TMF) lifecycle and develop and implement operational strategies to ensure inspection readiness, regulatory compliance, and high-quality documentation across clinical programs. Design and implement operational strategies and study management plans that support TMF completeness, quality, and compliance. 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. 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. Continuously assess TMF processes and systems for improvement opportunities; support the implementation of new tools and workflows that enhance operational efficiency and data integrity. 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 for internal and external stakeholders (e.g., vendors) for study-related matters. Maintain up-to-date knowledge of the therapeutic area/product candidates, clinical practice, competitors, and regulatory considerations. Support audits/inspections and resolutions of findings; participate in the development of new SOPs, guidelines, and/or working groups on new processes. Qualifications
Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred Minimum of 7 years’ relevant clinical research (or related) experience within the pharmaceutical industry Experience in leading and managing a team of professional staff Solid understanding of the drug development process and each step within the clinical trial process Experience 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 Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. CSL offers resources and benefits, from health care to financial protection, to support employees in doing work that matters. Benefits are designed to meet employees’ needs at every stage of life. Please review our benefits site to see what’s available to you as a CSL employee. About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. We discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular/metabolic, respiratory, and transplant therapeutic areas. We leverage plasma fractionation, recombinant protein technology, and cell and gene therapies to support continued innovation and address unmet medical needs. CSL Behring operates CSL Plasma (one of the world’s largest plasma collection networks). Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and serves patients in more than 100 countries. Inclusion & Belonging
At CSL, Inclusion and Belonging is at the core of our mission and who we are. By celebrating differences and fostering a culture of curiosity and empathy, we connect with patients and donors, sustain a diverse workforce, and move our company and industry forward. Learn more about Inclusion and Belonging at CSL.
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CSL's R&D organization is accelerating innovation to deliver greater impact for patients. Joining CSL means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. This is a hybrid Senior TMF Lead role located in King of Prussia, PA; Waltham, MA; Maidenhead, UK; or Zürich, Switzerland. The position is onsite three days a week and reports to the Senior Director, Head of Clinical Compliance & Specialty Ops. Senior TMF Lead – Responsibilities
Oversee the Trial Master File (TMF) lifecycle and develop and implement operational strategies to ensure inspection readiness, regulatory compliance, and high-quality documentation across clinical programs. Design and implement operational strategies and study management plans that support TMF completeness, quality, and compliance. 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. 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. Continuously assess TMF processes and systems for improvement opportunities; support the implementation of new tools and workflows that enhance operational efficiency and data integrity. 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 for internal and external stakeholders (e.g., vendors) for study-related matters. Maintain up-to-date knowledge of the therapeutic area/product candidates, clinical practice, competitors, and regulatory considerations. Support audits/inspections and resolutions of findings; participate in the development of new SOPs, guidelines, and/or working groups on new processes. Qualifications
Bachelor’s degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred Minimum of 7 years’ relevant clinical research (or related) experience within the pharmaceutical industry Experience in leading and managing a team of professional staff Solid understanding of the drug development process and each step within the clinical trial process Experience 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 Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. CSL offers resources and benefits, from health care to financial protection, to support employees in doing work that matters. Benefits are designed to meet employees’ needs at every stage of life. Please review our benefits site to see what’s available to you as a CSL employee. About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. We discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular/metabolic, respiratory, and transplant therapeutic areas. We leverage plasma fractionation, recombinant protein technology, and cell and gene therapies to support continued innovation and address unmet medical needs. CSL Behring operates CSL Plasma (one of the world’s largest plasma collection networks). Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and serves patients in more than 100 countries. Inclusion & Belonging
At CSL, Inclusion and Belonging is at the core of our mission and who we are. By celebrating differences and fostering a culture of curiosity and empathy, we connect with patients and donors, sustain a diverse workforce, and move our company and industry forward. Learn more about Inclusion and Belonging at CSL.
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