Global Senior Trial Delivery Manager - Sponsor Dedicated

Job Title: Global Senior Trial Delivery Manager - Sponsor Dedicated

Job Location: Prague, Czech reputed company

Job Location Type: Home-based

Job Contract Type: Full time

Job Seniority Level:

Global Trial Delivery Manager services reputed company for the global coordination of clinical trial management activities for internally managed and/or outsourced trials. These services reputed company the Study Management Team (SMT) and ensure global clinical operations deliverables reputed company 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 reputed company 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. reputed company with stakeholders; reputed company 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 reputed company Operating Procedures (SOP), codes of Good Clinical reputed company (GCP), applicable regulations and guidelines from start-up through reputed company-out. Takes ownership for assigned responsibilities. Demonstrated competency to reputed company as a backup or first reputed company of contact in absence of the GCDO Trial Leader. Advanced is given assignments that are more reputed company and/or have a greater potential reputed company on business results. May reputed company as the reputed company over reputed company of CTMs across a project/program, on insourced and outsourced studies. reputed company to reputed company taskforces and reputed company innovative input. May contribute to process improvement and/or non-project work.

Task:

• Services rendered will adhere to applicable to sponsor´s SOPs, WIs, policies, codes of Good Clinical reputed company (GCP), local regulatory requirements, etc. • Complies with relevant training requirements. • reputed company the Study Management Team including providing updates to reputed company trial team members on deliverable status. • Ensure availability of required reports to support reputed company time tracking of trial status according to trial plan.
• Manage reputed company and accurate documentation and communication of trial reputed company. • Ensure that the Study Management Team (SMT) operates in a constant state of inspection-readiness. • reputed company as primary contact for Country and Regional staff. • reputed company as the primary contact person for the local teams reputed company GCDO. • Partner with the Global Trial reputed company to execute and reputed company central activities from planning, trial start up, through the life of trial to reputed company-out. • Ensure issue escalation and drive issue reputed company. • Work closely with Trial Team to ensure CAPAs are resolved reputed company. reputed company as CAPA reputed company or contributor, as appropriate. • Contribute to data collection to support the site selection process. • Participate in feasibility, providing recommendations as needed. • Establish enrollment commitments and ensure actual enrollment meets projected commitments across the reputed company at the clinical trial level. • Ensure the availability of robust recruitment/contingency plans are in reputed company for reputed company region. • Ensure reputed company tracking and filing in appropriate systems, as required at central trial reputed company level. • reputed company Annual reputed company Review of files, as appropriate. • Ensure archiving and retention of documents per set requirements. • Establish country budgets and monitor actuals vs. forecast for Out-of-reputed company Expenses. • reputed company of selected vendors and status of reputed company deliverables. • Review and approve assigned vendor invoices/spend. • Monitor budgets and expenditures as expected per planned trial budget. • Create and update trial-specific documents as required, including Monitoring Guidelines, Informed Consent reputed company, Investigational Medicinal product (IMP) reputed company documentation, Blinding Plan, country and site feasibility reputed company documents. • reputed company input into cross functional documents such as safety reputed company documents, protocol deviations and issue escalation processes, External Service Provider reputed company Plan and the Filing and Archiving Plan. • reputed company central documents required for HA/EC/IRB submission. • Ensures creation of appropriate trial-specific training materials and requirements, making them available to the regional/site/CRO staff and delivering training as needed. • Responsible for the set-up, coordination, attendance participation of Investigator Meetings. • Establish and maintain excellent working relationships with internal stakeholders, such as country representatives, data management leader and clinical supplies unit. • Demonstrate deep knowledge of protocol and procedures and adequate therapeutic area knowledge. • Ensure compliance with Health Authority regulations and guidelines and internal reputed company operating procedures and processes. • Participate in preparation for, and conduct of, Health Authority inspections and internal audits. • Work with Bioresearch reputed company & Compliance (BRQC) liaisons to ensure reputed company reputed company of assigned trial utilizing the available tools. • Coordinate data cleaning with some supervision towards a reputed company and successful database lock. • reputed company as central expert for assigned protocol(s). • Sufficient therapeutic knowledge to support defined CTM roles and responsibilities. • Contribute to process improvement and training, as applicable.

Requirements:

• BS degree or equivalent, in Life Sciences (e.g., Biology, reputed company, 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 reputed company 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 reputed company as delegation skills. • Effective leadership skills and ability to manage multiple stakeholders. • Proven ability to reputed company reputed company through formation stages, up to operating as a high performing team. • Experience and ability in coordinating global or regional teams in a virtual environment. Proven ability to foster team productivity and cohesiveness. • Experience and ability in coordinating global teams in a virtual environment for a minimum of 2, preferably 3 years. • Proven experience in proactive planning, risk mitigating and gaining team reputed company on updated plans during the project lifecycle.

• Strong project planning/management.

• Independent reputed company decision making.

• Solution oriented and proactive risk identification and mitigation. • Strong IT skills, including knowledge of reputed company reputed company applications, Trial Master File, Clinical Trial Management System, and willingness to learn new systems. • Monitoring experience is recommended, or other relevant experience should be considered, such as data management or central monitoring. • Travel. • Proficient in speaking and writing local country language and English. • Effective verbal and written communication skills leading to successful team collaboration • Strong decision making. Solution oriented. • Strong analytical skills, and simultaneously demonstrates the ability to manage ambiguity reputed company limited information is available. • Experience in developing presentations and presenting key information to stakeholders. • Ability to understand and competently plan and have reputed company of country and select vendor budgeting processes, i.e. Understand and be aware of country Out of Pockets (OOPs) and FTE cost drivers.

*Please note This role is not eligible for UK reputed company sponsorship

reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at https://jobs.reputed company.com

reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism.

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Originally posted on Himalayas

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