Global Senior Trial Delivery Manager - Sponsor Dedicated
1 day ago
Madrid
ppGlobal Trial Delivery Manager services provide for the global coordination of clinical trial management activities for internally managed and/or outsourced trials. These services lead the Study Management Team (SMT) and ensure global clinical operations deliverables progress according to agreed upon timelines and milestones, including country site feasibility and site selection, trial set‑up, trial execution and trial closure and vendor set‑up activities as assigned by the Global Clinical Development Operations Trial Leader (GTL). This service supports the GTL in leading related CRO, country, and site activities, including global vendors involved in site facing activities such as IVRS, Central Lab, ePRO, Imaging, Translation, Printing, Ancillary supplies and Meeting Planners. Interface with stakeholders; internal and external to Global Clinical Development Operations (GCDO) functions, such as Study Responsible Physician, Global Data Manager, Trial Supply Manager, CRO staff, vendor staff and trial sites (if applicable). Work closely with the GCDO Trial Leader (GTL) and is member of the Trial Team, led by the GTL. Ensure inspection readiness through compliance with the clinical research protocol, company Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start‑up through close‑out. Takes ownership for assigned responsibilities. Demonstrated competency to act as a backup or first point of contact in absentia of the GCDO Trial Leader. Advanced is given assignments that are more complex and/or have a greater potential impact on business results. May act as the lead over a team of CTMs across a project/program, on insourced and outsourced studies. Able to lead taskforces and provide innovative input. May contribute to process improvement and/or non‑project work. /p h3Task /h3 ul liServices rendered will adhere to applicable sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc. /li liComplies with relevant training requirements. /li liLead the Study Management Team including providing updates to all trial team members on deliverable status. /li liEnsure availability of required reports to support real‑time tracking of trial status according to trial plan. /li liManage timely and accurate documentation and communication of trial progress. /li liEnsure that the Study Management Team (SMT) operates in a constant state of inspection‑readiness. /li liAct as primary contact for Country and Regional staff. /li liAct as the primary contact person for the local teams within GCDO. /li liPartner with the Global Trial Lead to execute and oversee central activities from planning, trial start‑up, through the life of trial to close‑out. /li liEnsure issue escalation and drive issue resolution. /li liWork closely with Trial Team to ensure CAPAs are resolved timely. Act as CAPA owner or contributor, as appropriate. /li liContribute to data collection to support the site selection process. /li liParticipate in feasibility, providing recommendations as needed. /li liEstablish enrollment commitments and ensure actual enrollment meets projected commitments across the regions at the clinical trial level. /li liEnsure availability of robust recruitment/contingency plans for each region. /li liEnsure timely tracking and filing in appropriate systems, as required at central trial oversight level. /li liPerform Annual Quality Review of files, as appropriate. /li liEnsure archiving and retention of documents per set requirements. /li liEstablish country budgets and monitor actuals vs. forecast for Out‑of‑Pocket Expenses. /li liOversight of selected vendors and status of related deliverables. /li liReview and approve assigned vendor invoices/spend. /li liMonitor budgets and expenditures as expected per planned trial budget. /li liCreate and update trial‑specific documents as required, including Monitoring Guidelines, Informed Consent Form, Investigational Medicinal Product (IMP) related documentation, Blinding Plan, country and site feasibility related documents. /li liProvide input into cross‑functional documents such as safety related documents, protocol deviations and issue escalation processes, External Service Provider Oversight Plan and the Filing and Archiving Plan. /li liProvide central documents required for HA/EC/IRB submission. /li liEnsures creation of appropriate trial‑specific training materials and requirements, making them available to the regional/site/CRO staff and delivering training as needed. /li liResponsible for the set‑up, coordination, attendance participation of Investigator Meetings. /li liEstablish and maintain excellent working relationships with internal stakeholders, such as country representatives, data management leader and clinical supplies unit. /li liDemonstrate deep knowledge of protocol and procedures and adequate therapeutic area knowledge. /li liEnsure compliance with Health Authority regulations and guidelines and internal standard operating procedures and processes. /li liParticipate in preparation for, and conduct of, Health Authority inspections and internal audits. /li liWork with Bioresearch Quality Compliance (BRQC) liaisons to ensure quality oversight of assigned trial utilizing the available tools. /li liCoordinate data cleaning with some supervision towards a timely and successful database lock. /li liAct as central expert for assigned protocol(s). /li liSufficient therapeutic knowledge to support defined CTM roles and responsibilities. /li liContribute to process improvement and training, as applicable. /li /ul h3Requirements /h3 ul liBS degree or equivalent, in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy). /li li6‑8 years clinical trial management experience in the pharmaceutical industry or CRO. Specific therapeutic area experience. /li liStrong working knowledge of ICH‑GCP, local laws and regulations. /li liSuperior clinical research operational knowledge. Proven track record in successfully managing various aspects of trials from start‑up to database lock and trial closure. /li liDemonstrated effective leadership to proactively drive the Study Management Team through key stages of trials, and delegation skills. /li liEffective leadership skills and ability to manage multiple stakeholders. /li liProven ability to lead a team through formation stages, up to operating as a high‑performing team. /li liExperience and ability in coordinating global or regional teams in a virtual environment. Proven ability to foster team productivity and cohesiveness. /li liExperience and ability in coordinating global teams in a virtual environment for a minimum of 2, preferably 3 years. /li liProven experience in proactive planning, risk mitigation, and gaining team consensus on updated plans during the project lifecycle. /li liStrong project planning/management. /li liIndependent complex decision making. /li liSolution‑oriented and proactive risk identification and mitigation. /li liStrong IT skills, including knowledge of standard Microsoft applications, Trial Master File, Clinical Trial Management System, and willingness to learn new systems. /li liMonitoring experience is recommended, or other relevant experience should be considered, such as data management or central monitoring. /li liTravel. /li liProficient in speaking and writing local country language and English. /li liEffective verbal and written communication skills leading to successful team collaboration. /li liStrong decision making. Solution‑oriented. /li liStrong analytical skills, and simultaneously demonstrates the ability to manage ambiguity when limited information is available. /li liExperience in developing presentations and presenting key information to stakeholders. /li liAbility to understand and competently plan and have oversight of country and select vendor budgeting processes, i.e. Understand and be aware of country Out of Pockets (OOPs) and FTE cost drivers. /li liPlease note This role is not eligible for UK visa sponsorship. /li /ul /p #J-18808-Ljbffr
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