ppbThis position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a TMF Team Lead based in Spain. /b /ppThis role offers the opportunity to lead critical Trial Master File operations within a global clinical research environment. /ppYou will ensure inspection readiness, compliance, and high-quality document management across multiple clinical studies. /ppThe position combines operational leadership, quality oversight, and collaboration with international project teams and stakeholders. /ppYou will play a key role in maintaining regulatory standards while improving processes and supporting successful clinical trial delivery. /ppWorking with multidisciplinary teams, you will use data-driven insights and strong organizational skills to manage complex documentation activities. /ppThis is an impactful opportunity for a detail-oriented professional who wants to contribute to advancing healthcare and improving patient outcomes. /ph3Accountabilities: /h3ulliThe TMF Team Lead will oversee Trial Master File operations, ensuring compliance with regulatory requirements, internal procedures, and industry best practices. This role requires strong leadership, analytical thinking, and the ability to collaborate with global teams to maintain document quality and inspection readiness. /liliLead and support the delivery of TMF services across multiple clinical studies. /liliEnsure Trial Master Files remain inspection-ready and compliant with applicable regulations, procedures, and ALCOA principles.



/liliPerform Records Management Compliance (RMC) oversight activities and monitor documentation quality. /liliTrack key performance indicators and communicate performance insights to project teams and external stakeholders. /liliIdentify operational risks, develop mitigation strategies, and support continuous improvement initiatives. /liliAnalyze TMF data and apply insights to drive informed, data-based decisions. /liliDevelop and maintain project-specific Quality Management Documents. /liliProvide guidance and expertise on TMF-related topics to project team members. /liliMentor, support, and develop team members while promoting a collaborative working environment. /liliCollaborate with internal teams, sponsors, external partners, and quality assurance stakeholders. /li /ulh3Requirements: /h3ulliThe ideal candidate has experience in clinical research operations, strong knowledge of regulatory requirements, and the ability to manage complex documentation processes in a highly regulated environment. You should be analytical, organized, and comfortable leading teams while working with general stakeholders. /liliUniversity degree preferred, ideally in Life Sciences or a related field.



/lili3--5 years of relevant experience combining education and professional background. /liliStrong understanding of ICH Good Clinical Practice (GCP) guidelines. /liliExperience supporting regulatory inspections, including FDA, PMDA, EMA, BfArM, MHRA, or similar authorities. /liliHands-on experience with document management systems and/or electronic Trial Master File (eTMF) solutions such as Veeva, Trial Interactive, or Documentum. /liliExperience working within regulated industries, preferably clinical research or pharmaceuticals. /liliStrong analytical skills with the ability to evaluate complex situations using multiple sources of information. /liliExcellent interpersonal and communication skills in a fast-paced, changing environment. /liliAbility to manage multiple priorities while maintaining accuracy and attention to detail. /liliExperience mentoring, training, or managing team members is highly valued. /li /ulh3Benefits: /h3ulliOpportunity to contribute to meaningful healthcare projects that improve patient outcomes. /liliGlobal and collaborative work environment with multidisciplinary teams. /liliRemote work flexibility. /liliSupportive culture focused on inclusion, collaboration, and professional growth. /liliCareer development opportunities and access to learning resources. /liliExposure to international clinical research projects and industry-leading practices. /liliOpportunity to work with experienced professionals across global teams. /li /ul /p #J-18808-Ljbffr

📌 TMF Team Lead (España)
🏢 Tamarind Intelligence
📍 España