Clinical Trial Manager Ii

hace 4 semanas


Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completo

Location: Barcelona, Spain

Job reference: R-184201

Date posted: 11/07/2023

**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 study-specific 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 ClinTrials.gov/EUdract 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 cross-functional 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 cross-functional team to assemble study documents as appendices for CSR at study close-out.
- 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 office-based 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 non-linear 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.


  • Clinical Trial Manager Ii

    hace 4 semanas


    Barcelona, España Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager II** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient...


  • Barcelona, España Syneos - Clinical and Corporate - Prod A tiempo completo

    **Description** Sponsor Dedicated Clinical Trial Manager II/ Sr CTM - Home Based in SPAIN **Experience as CTM in the management of global/multiple-countries studies and different types of vendors is required.** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique...


  • Barcelona, España Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our...


  • Barcelona, España Syneos Health Clinical A tiempo completo

    **Overview** The Clinical Trial Ambassador will establish, cultivate, and maintain scientific relationships with investigators and study coordinators to support enrollment while developing a strong understanding of clinical practice as it relates to areas of interest. This position interacts with various internal and external stakeholders, with a focus on...

  • Clinical Data Manager Ii

    hace 4 semanas


    Barcelona, España AstraZeneca A tiempo completo

    **Location**:Barcelona **About AstraZeneca** AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development, and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to...


  • Barcelona, España Syneos Health Clinical A tiempo completo

    **Description** **Senior Clinical Project Manager** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help...


  • Barcelona, España Syneos Health Commercial Solutions A tiempo completo

    **Overview** The Clinical Trial Ambassador will establish, cultivate, and maintain scientific relationships with investigators and study coordinators to support enrollment while developing a strong understanding of clinical practice as it relates to areas of interest. This position interacts with various internal and external stakeholders, with a focus on...


  • Barcelona, España Vall d'Hebron Institut de Recerca A tiempo completo

    VHIR-RRHH-FOR-003_vs01_ TheVall d'Hebron Research Institute (VHIR) is a public sector institution that promotes and develops the research, innovation and biosanitary teaching of the Vall d’Hebron University Hospital. Through the excellence of our research, we identify problems of society and we contribute to spread them around the world. In April...

  • Clinical Trial Manager I

    hace 4 semanas


    Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completo

    Location: Barcelona, Spain Job reference: R-197634 Date posted: 04/18/2024 **This is what you will do**: - Support the CPLs and CTMs for business administrative tasks, especially for trial master file creation, maintenance, closure, and transfer for a single product and multiple studies per company or CRO SOPs. Handle centralized business process tasks,...

  • Clinical Trials Manager

    hace 24 horas


    Barcelona, España Ab-Biotics, S.A. A tiempo completo

    AB-Biotics was founded in 2004 as a spin-off of the Autonomous University of Barcelona (UAB), now it is a leading biotechnology company, with an international vocation, and it divides its activities into these two main business areas (probiotics & precision medicine) based on research, development, intellectual protection and the distribution of their own...


  • Barcelona, España AstraZeneca A tiempo completo

    **About Evinova** The Digital Health R&D Recruitment team enables better patient and healthcare professional experiences by delivering customer-centric digital solutions for clinical trials and real-world healthcare. The focus of this role is to work with platform owners, global study teams, and TAs, plus vendors to drive an enterprise-level contact center...


  • Barcelona, España TFS HealthScience A tiempo completo

    **Join Our Team as a Clinical Data Manager** **About this role** TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing and Functional Service (FSP)...


  • Barcelona, España Vall d'Hebron Institut de Recerca A tiempo completo

    VHIR-RRHH-FOR-003_vs01_ TheVall d'Hebron Research Institute (VHIR) is a public sector institution that promotes and develops the research, innovation and biosanitary teaching of the Vall d’Hebron University Hospital. Through the excellence of our research, we identify problems of society and we contribute to spread them around the world. In April...


  • Barcelona, España Morgan Philips Executive Search A tiempo completo

    Important Pharmaceutical Company is looking for a Global Study Manager - Early Oncology Clinical: The Global Study Manager is responsible for supporting the delivery of clinical studies ensuring quality and compliance. **Responsabilities**: Contribute to the development of study documents as appropriate as well as any updates/amendments, ensuring template...


  • Barcelona, España AstraZeneca A tiempo completo

    **Location**:Barcelona **About AstraZeneca** AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development, and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to...


  • Barcelona, España TFS HealthScience A tiempo completo

    **About this role** TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing and Functional Service (FSP) solutions. - As part of our SRS/FSP team, you...


  • Barcelona, España Astrazeneca Gmbh A tiempo completo

    Location: Barcelona, Spain (on-site) / Able to be office based (3 days per week) in the Barcelona office from day 1. For candidates living in other locations requiring relocation, candidate should be able to relocate and start in the AZ role within 2 months once offer is accepted. AZ will not provide relocation package for this role. The Global Study Manager...


  • Barcelona, España Fortrea - Organic A tiempo completo

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...


  • Barcelona, España Fortrea A tiempo completo

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Etmf Project Manager

    hace 3 semanas


    Barcelona, España Transperfect A tiempo completo

    eTMF Project Manager - Trial Interactive page is loaded eTMF Project Manager - Trial Interactive Apply locations Spain-Barcelona time type Full time posted on Posted 30+ Days Ago job requisition id R2019-7318 TransPerfect Is More Than Just a Job… Our greatest asset is our people, and nothing is more important to us than ensuring that everyone knows that....