Intern Service Delivery Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8mwwhz

Global 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. 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. 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. Services rendered will adhere to applicable to sponsor´s SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements,



etc. Complies with relevant training requirements. Lead the Study Management Team including providing updates to all trial team members on deliverable status. Ensure availability of required reports to support real time tracking of trial status according to trial plan. Manage timely and accurate documentation and communication of trial progress. Ensure that the Study Management Team (SMT) operates in a constant state of inspection-readiness. Act as the primary contact person for the local teams within GCDO. Partner with the Global Trial Lead to execute and oversee central activities from planning, trial start up, through the life of trial to close-out. Contribute to data collection to support the site selection process. Establish enrollment commitments and ensure actual enrollment meets projected commitments across the regions at the clinical trial level. Ensure timely tracking and filing in appropriate systems, as required at central trial oversight level. Ensure archiving and retention of documents per set requirements. Review and approve assigned vendor invoices/spend. Create 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.



Provide 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. Ensures creation of appropriate trial-specific training materials and requirements, making them available to the regional/site/CRO staff and delivering training as needed. Establish and maintain excellent working relationships with internal stakeholders, such as country representatives, data management leader and clinical supplies unit. Ensure compliance with Health Authority regulations and guidelines and internal standard operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal audits. Work with Bioresearch Quality & Compliance (BRQC) liaisons to ensure quality oversight of assigned trial utilizing the available tools. Coordinate data cleaning with some supervision towards a timely and successful database lock. Sufficient therapeutic knowledge to support defined CTM roles and responsibilities. Contribute to process improvement and training, as applicable. BS degree or equivalent, in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy). ~6-8 years clinical trial management experience in the pharmaceutical industry or CRO. Specific therapeutic area experience. ~ Strong working knowledge of ICH-GCP, local laws and regulations. ~ Superior clinical research operational knowledge. Proven track record in successfully managing various aspects of trials from start-up to database lock and trial closure. ~ Demonstrated effective leadership to proactively drive the Study Management Team through key stages of trials, as well as delegation skills. ~ Proven abil

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8mwwhz