Study Start-up Lead

ppDescription /p h3JOB SUMMARY /h3 pThe Study Start-up Lead (SSUL) reports to the Global Feasibility, Regulatory and Start-up Head and is responsible for leading and overseeing the full lifecycle of regulatory submissions for clinical trials conducted globally or regionally till last participant site is activated, ensuring startup deliverables and timelines achieved. This role provides strategic submission planning, cross-functional coordination, and subject matter expertise (SME) while ensuring timely, high-quality control, and compliant submissions across the NA and ROW. The SSUL is a senior technical leadership role, who plays a pivotal role in mentoring junior team members without direct line management responsibilities. The SSUL will work in accordance with company policies, SOPs, regulatory requirements in addition to financial and contractual obligations. /p h3RESPONSIBILITIES /h3 ul liRegulatory submission and cross-functional Leadership /li liEnsure all startup activities for projects are performed on time, within the scope and budget and in compliance with ICH/GCP guidelines, SOPs and protocol requirements /li liTogether with the study, Project Manager manages the strategic aspects of projects startup and mitigating any risk setting up the proper action plan. /li liProvide oversight and coordinate SSU Specialists, assigned to their programs being the initial point of contact and supporting them with startup activities and investigative sites' liaison. Ensure all assigned SSU Specialists are adequately trained on project specific systems and procedures /li liServe as SME for EU CTR and CTIS processes, interpreting regulatory expectations /li liLead planning and execution of Initial CTAs, Part I II submissions, Substantial Modifications (SMs), and all CTIS lifecycle activities for Europe and other countries and regions as well. /li liOversee preparation and submission of Requests for Information (RFIs), ensuring high-quality and timely responses. /li liProvide subject matter expertise for end-of-study activities, including End-of-Trial (EoT) notifications, Summary of Results, Lay Summary, CSR and CSRr submissions. /li liConduct quality oversight and ensure alignment with EU CTR, EMA guidance, and internal standards operating procedures /li liDevelop and maintain Startup plan and timelines for their projects and track progress ensuring project deliverables and milestones are reached. /li liEnsure adequate resource allocation of Start Up specialists on the project, in collaboration with the respective line managers. /li liResponsible for coordinating EC/IRB and regulatory submissions or any other notification requested by the scope of the protocol. /li liEnsure and oversight the proper adaptation of Subject Information and lnformed Consent documents according to local law and requirements. /li liEnsure all Start Up documentation is submitted properly and on time to the Trial master File. /li liExecute the Greenlight forms, ensuring all documents are in place and approved. /li liMeasure and evaluate project startup deliverables and metrics. /li liUpdate the Project Manager and customer with status of start-up progress and ensure a proper escalation of any issue detected. /li liSupport the Line management ensuring the maintenance of site, country and regional Start Up requirements and timelines database on the central repository (EC/IRB submission, Regulatory package, Clinical Trial Agreements specification) and compliance with those requirements. /li liSupport Business development activities participating in capability presentations/bid defenses and being part of the proposals strategic discussion. /li liProvide performance feedback of the team members to the corresponding Line Manager. /li liEnsure submissions adhere to EU CTR 536/2014, ICH-GCP, EMA guidance, and any other national requirements. /li liSupport audits and inspections related to submission activities. /li liContribute to the development and maintenance of SOPs, work instructions, and templates. /li /ul h3TRAVELING /h3 pPer study requirements (global travel may be required). /p h3Requirements /h3 ul liBachelor’s or master’s degree in Life Sciences or related field. /li li3+ years’ experience working in global regulatory environment with EU CTR submissions and advanced CTIS expertise being a must. CTIS system expertise is required /li liStrong understanding of EU CTR timelines, dossier content, and results of reporting. /li liProven ability to lead complex submission programs. /li liExcellent communication, prioritization, and problem-solving skills. /li liExperience in pharma, biotech, or CRO. /li liKnowledge of ICH guidelines, Good Clinical Practice regulations, regulatory intelligence, and EU regulatory strategy. /li liStrategic thinking with cross-functional leadership experience /li liProblem-solving and analytical skills /li liHigh attention to detail /li liExcellent communication and presentation skills in bid defense or customer meeting /li /ul /p #J-18808-Ljbffr