Study Delivery Lead
Siena, Siena, Italy
1 gg fa

Site Name : Italy - Siena

Posted Date : Jul 29 2022

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    Join our challenge to get Ahead Together.

    Job Title

    GVGH Study Delivery Lead (Fixed Term - 3 years)

    In this role you will

    Coordinates activities as described in the GVGH Clinical Management Plan and as per project timelines including forecast, detailed schedule, and quality management of clinical trial activities

    Ensures a study-level risk assessment is performed and that identified risks are appropriately treated, ensures issue escalation and management up to resolution.

    In partnership with the GVGH Project Physician (and with support by GVGH Biostatistician, GVGH Regulatory Affairs and Head of Clinical Operations), co-ordinates all members of the study network to ensure the appropriate experts are involved at appropriate stages and outputs are delivered on time

    Leads and oversees operational activities in study design and study execution including preparation of study documents (Informed Consent, eCRF, diary cards, study manuals, etc) and inputs to protocol development, to ensure optimal operational design, ensures that study documents are available for timely submission to Ethics Committees and / or Regulatory Authorities, according to local requirements

    Maintaining regular contact with site staff and all other partners involved in GVGH clinical trial activities from the preparatory phase (study set-up and initiation) through study conduct and closure

    Responsible for vendor management activities including selection and contract development

    Develops and follows the most efficient operating model for study outsourcing, including fully outsourced studies

    GSK Vaccines Institute for Global Health (GVGH) is a GSK-owned company, part of the GSK Global Health organization, committed to develop vaccines for major neglected diseases of impoverished communities.

    GSK Global Health organisation is aimed to improve the health of people in the world’s poorest countries and to improve health security globally.

    Global Health approach is a central pillar of GSK’s Trust agenda and a key part of what makes us GSK.

    The GVGH Study Delivery Lead (SDL) is the Project Manager of a clinical study managed by GVGH, accountable to ensure that the study team is planning and executing the study according to time, budget and quality and as defined in the Development Plans, in the study protocol, and in adherence with ICH-GCP guidelines, GSK Vaccines and GVGH control documents and within regulatory requirements.

    GVGH SDL has the responsibility to track budget for the studies he / she is responsible for.

    The GVGH SDL is the single point of contact for the integrated operational planning, design, operational feasibility and delivery of their study(ies) from commit to study idea until publication.

    Within the GVGH CDRA department, the GVGH SDL supports process improvements and participates in working groups as applicable.

    Why you?

    Qualifications & Skills :

    Scientific Degree in Pharmacy, Chemistry, Bio Engineer, Biology, Biomedical Sciences

    At least 2 years (SDL) of significant experience in managing clinical research studies, clinical operations or equivalent.

    Good understanding of the clinical research and clinical trial management, associated regulatory, processes and quality requirements.

    Strong skills and experience in project management and tools

    In-depth knowledge of GCPs and ICH guidelines

    Excellent communication and presentation skills

    Solid experience working in teams with a broad range of cultures

    Previous experience in field monitoring (knowledge of and experience with international clinical studies) desirable

    Effective at problem solving and conflict resolution

    Preferred Qualifications & Skills :

    Able to lead and work within teams and networks across functional and geographical boundaries; Experience with cross-cultural teams highly desirable

    Able to set and manage priorities, performance targets and project initiatives. Demonstrates conceptual, analytical and strategic thinking, effective at problem solving and conflict resolution

    Able to understand the impact of technology on studies and to use and develop computer skills while making appropriate use of GSK Vaccines systems / software

    Excellent English language written and verbal communication skills

    Available to travel internationally up to 40% (applicable only in case local clinical trial operations are not delegated to a CRO but performed centrally by GVGH).

    Inclusion & Diversity at GSK :

    Inclusion and diversity at GSK are key for our success. Here, you will thrive through bringing your unique experiences to both our company and the recruitment process.

    We want you to be you, feel good and keep growing your career.

    GSK is an Equal Opportunity and Affirmative Action Employer. Applicants will travel through a transparent recruitment journey that adheres to all required employment standards and regulations.

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