Global Study Manager, Oncology R&d, Early Oncology - Barcelona, España - AstraZeneca

AstraZeneca

Empresa verificada

Barcelona, España

hace 2 semanas

Publicado por:

Isabel García

beBee Recruiter

Descripción

Role Description Role Description**The Global Study Manager is responsible for supporting the delivery of clinical studies ensuring quality and compliance. The exact accountabilities will differ depending on the exact nature of the clinical program, so a high degree of flexibility is required.

Typical Accountabilities

Contribute to the development of study documents as appropriate as well as any updates/amendments, ensuring template and version compliance.
Manage the setup of thirdparty vendors assessing initial statement of work and budget, as well as the change order process.
Provide input to data management documents (e.g. Case Report Form, Data Validation Specifications), and interface with data management representatives and sites to facilitate the delivery of study data.
Initiate contract/budget requests and track ongoing status; facilitate generation of purchase orders, review vendor invoices and assist in tracking spend against approved budget.
Ensure the supply of Investigational product and study materials by liaising with Drug Supply or external service providers as appropriate.
Oversight of third party vendors, global / local internal staff and investigator sites to support effective delivery of a study and its regulatory documents from development of the protocol through to the Clinical Study Report.
Provide oversight of and support recruitment and data delivery as well as risk mitigation strategies.
Assist in the clinical trial insurance process; track approvals, revisions and renewals of certificates.
Monitor study conduct and progress, proactively identifying and resolving issues which may impact delivery of the study to the necessary quality, timelines or budget.
Support risk management and quality efforts to ensure study compliance.
Support setup, maintenance, closeout and archiving of the Trial Master File (TMF), ensuring continual inspection readiness.
Prepare presentation material for meetings, newsletters and websites.
Support the study team in the implementation of audits and regulatory inspections.
Contribute to review of new/amended/unique SOPs and guidance documents.

Education, Qualifications, Skills and Experience

University degree / Bachelor's degree, preferably in medical or biological science, or discipline associated with Clinical Research, or equivalent experience
Minimum of 34 years of progressive clinical trial experience
Experience of working with and delivering through strategic partners and 3rd party vendors
Excellent knowledge of ICH-GCP principles
Team orientated
Ability to coordinate and prioritise multiple tasks and deliverables
Proactive approach
High degree of flexibility
Demonstrated verbal and written communication skills
Good negotiation and collaboration skills
Demonstrated interpersonal and problemsolving skills
Some travel may be required

Desirable