Clinical Trial Manager Ii - Barcelona, España - Alexion Pharmaceuticals,Inc.

Alexion Pharmaceuticals,Inc.

Empresa verificada

Barcelona, España

hace 3 semanas

Publicado por:

Isabel García

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Descripción

Location:
Barcelona, Spain

Job reference:
R-196792

Date posted: 04/08/2024

This is what you will do:

Assist the CPLs for the planning, implementation, execution and compliance of operational plans for clinical study/program with multiple clinical vendors in order to maintain inspection readiness.

This is a tactical position and involves protocol execution at the site level via established vendor oversight and escalation pathways.

Serve as a peer mentor for staff, as needed.

Ensure quality of the trial master file through content (QC) review of document packages submitted for entry into the TMF and liaise with the TMF specialist to resolve any issues identified with the documents submitted.

Depending on the program scope, the CTM II may have study level responsibilities similar to any other CTM.

You will be responsible for:

Customizing/updating any studyspecific plans and process flows for multiple clinical vendors, as appropriate e.g., site training plan, site monitoring plan, cross functional data review plan, IP release plan etc.
Assisting the CPL by tracking compliance to all study level plans and escalating any variances.
Serving as system expert and point of contact for business technologies used during the study (e.g., EDC, Investigator Portal, TMF).
Ensuring CRA compliance with the study parameters and track escalation and closure of action items noted in the monitoring visit reports (Late Phase studies only).
Ensuring registration of a protocol in and monitoring its update throughout a study's life cycle for compliance with the regulations and SOP.
Assisting CPL with interactions with CRO and site staff to adhere to study budgets, requesting accruals, and performing contract and invoice review.
Participating in operation meetings with CRO, and crossfunctional team members; documenting escalations and actions.
Coordinating study team training in the investigator portal; monitoring site/CRA user access and tracking compliance during the study.
Coordinating with CPL and crossfunctional team to assemble study documents as appendices for CSR at study closeout.
Serving as SME for initiatives in conjunction with the Center of Excellence, as required to ensure consistent implementation of best practices across all studies and within a franchise.

You will need to have:

Bachelor's degree or equivalent in one of the disciplines related to clinical practice/health care, life sciences, or drug development
Excellent written and verbal skills and strong interpersonal skills
The duties of this role are generally conducted in an office environment. As is typical of an officebased role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and nonlinear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

>3 years of clinical research experience/in the pharmaceutical industry with a solid understanding of technology and processes used in drug development.
Worked with CROs and vendors to drive timelines and deliverables.
Experience working with study budgets and forecasting; contract and invoice review.
Research certification desirable.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.