Senior Clinical Trial Manager

hace 4 semanas

Gasteiz Vitoria, Álava, España Pharmiweb A tiempo completo

Job Summary

We are seeking a highly skilled Senior Local Trial Manager to join our team at Pharmiweb. As a Senior Local Trial Manager, you will be responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with assigned protocol, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory requirements.

Key Responsibilities

  • Country do-ability and site feasibility assessment in conjunction with CTA, CRA, and PM
  • Implementing local criteria for site selection
  • Ensuring consistent conduct of pre-trial assessment visits and instructing teams on appropriate follow-up of pre-trial visit report and country feasibility report
  • Recommending suitable sites for selection to participate in trial
  • Collaborating with the CPL, PM, local management/Country Head, and Protocol Owner to select final site list
  • Contributing input to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan, and Investigational Product documents at a country level or initiating development of these plans for a single country trial
  • Leading and coordinating local trial team activities in compliance with GCO Standard Operating Procedures (SOP), Work Instructions (WI), and applicable regulations
  • Leading local project planning activities to meet recruitment targets and to deliver high-quality data on time and within study budget
  • Ensuring that all SAEs/PQCs are reported within reporting timelines and documented as appropriate
  • Maintaining and updating trial management systems (e.g., CTMS, eTMF/LAF, Trial Master Source, and Sharepoints)
  • Using study tools and management reports available to analyze trial progress
  • Monitoring country progress and initiating corrective and preventive actions when the trial deviates from plans and communicating study progress and issues to study management teams
  • May submit requests for vendor services and may support vendor selection
  • Leading negotiation of trial site contracts and budgets
  • Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered within budget
  • Adheres to finance reporting deliverables and timelines
  • Attends/participates in Investigator Meetings as needed
  • May schedule and conduct a local/country investigator meeting
  • Conducts local trial team meetings and provides or facilitates CRA training when needed
  • Reviews and approves Monitoring Visit Reports submitted by CRA; identifies issues and/or trends across a trial project and escalates deviation issues to the PM and FM as needed
  • Reviews and approves site and local vendor invoices as required
  • Works with CRA to ensure CAPP is implemented for audits and inspection or any quality-related visits
  • Complies with relevant training requirements
  • Acts as local expert for assigned protocols
  • Develops strong therapeutic knowledge to support roles and responsibilities
  • May represent Global Clinical Operations on cross-functional teams
  • Acts as primary local/country contact for a trial
  • Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, study trial coordinators, and other site staff; and internal stakeholders, including Medical Affairs and Marketing for Medical Affairs trials
  • Actively contributes to process improvement

Requirements

  • A minimum of a BA/BS degree is required
  • A degree in a health or science-related field is preferred
  • Experience as LTM/CTM of at least 4/5 years
  • Experience in submissions
  • Specific therapeutic area experience may be required depending on the position
  • Should have a basic understanding of the drug development process, including ICH/GCP, and local regulatory requirements
  • Solid communication and computer skills required
  • Proficient in speaking and writing the country language and English language
  • Good written and oral communication skills

About Us

Pharmiweb is a leading clinical research organization that provides high-quality services to the pharmaceutical and biotechnology industries. We are committed to delivering exceptional results and building long-term relationships with our clients and employees.

What We Offer

We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development. Our benefits include various annual leave entitlements, a range of health insurance offerings, competitive retirement planning, and a global employee assistance program.

  • Clinical Trial Lead

    hace 3 semanas

    Gasteiz / Vitoria, Álava, España Pharmiweb A tiempo completo

    Clinical Trial Manager Role SummaryWe are seeking a skilled Clinical Trial Manager to join our team at ICON in a Sponsor Dedicated position. This critical role involves overseeing the planning, execution, and successful completion of clinical trials, ensuring adherence to timelines, budgets, and regulatory guidelines.Key ResponsibilitiesPlan and Manage...

  • Clinical Trial Operations Manager

    hace 1 mes

    Gasteiz / Vitoria, Álava, España Pharmiweb A tiempo completo

    Job Summary:As a leading global contract research organization (CRO), we provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, we are transforming drug...

  • Senior Clinical Project Manager

    hace 2 semanas

    Gasteiz / Vitoria, Álava, España Pharmiweb A tiempo completo

    Project Leadership and Delivery: Our ideal candidate will manage projects as a project manager overseeing interdisciplinary clinical research studies and ensuring compliance with GCP, relevant SOPs, and regulatory requirements. As a primary liaison between the Company and the Customer, this person will ensure timely study launch, conduct, and closeout...

  • Clinical Research Associate

    hace 4 semanas

    Gasteiz / Vitoria, Álava, España Pharmiweb A tiempo completo

    Job Summary:We are seeking a highly skilled Clinical Research Associate - Legal Contract Manager to join our team at Pharmiweb. As a key member of our clinical operations team, you will be responsible for managing country deliverables, timelines, and results for assigned protocols to meet country commitments.Key Responsibilities:Responsible for execution and...

  • Clinical Research Associate II

    hace 7 días

    Gasteiz / Vitoria, Álava, España Pharmiweb A tiempo completo

    About This RoleWe are seeking a Clinical Research Associate II to join our Clinical Operations Team in Spain. This role can be office-based in Madrid or decentralized in the regions of Madrid or Barcelona. As a Clinical Research Associate II, you will be accountable for using your expertise to build and maintain the site relationship and ensure they're set...

  • Clinical Research Associate

    hace 4 semanas

    Gasteiz / Vitoria, Álava, España Pharmiweb A tiempo completo

    Job SummaryAs a leading global contract research organization (CRO), Pharmiweb 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 conducting operations in more than 90 countries, Pharmiweb is...

  • Clinical Operations Manager

    hace 1 mes

    Gasteiz / Vitoria, Álava, España Enloe Medical Center A tiempo completo

    Job Summary:The Nurse Manager of Ambulatory Operations is responsible for the coordination and supervision of the daily clinical operations of the outpatient specialty clinics. This role participates in planning, coordinates the implementation, and evaluates department programs/services. The Nurse Manager is responsible for carrying out assignments to assure...

  • Clinical Research Associate II

    hace 4 semanas

    Gasteiz / Vitoria, Álava, España Pharmiweb A tiempo completo

    Job Summary:As a Clinical Research Associate II at Pharmiweb, you will be responsible for site management and monitoring of clinical studies. This role requires a thorough understanding of ICH GCP Guidelines and local regulatory requirements.Key Responsibilities:Conduct site monitoring responsibilities for clinical trials according to Pharmiweb's Standard...

  • Senior Clinical Research Associate I

    hace 4 semanas

    Gasteiz / Vitoria, Álava, España Pharmiweb A tiempo completo

    Job SummaryPharmiweb is seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for site monitoring and site management, ensuring the integrity of clinical studies and data.Key ResponsibilitiesConduct site monitoring and site management activities, including routine monitoring and...

  • Clinical Research Associate I

    hace 1 mes

    Gasteiz / Vitoria, Álava, España Pharmiweb A tiempo completo

    Job SummaryAs a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Pharmiweb 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...

  • Clinical Research Associate II

    hace 3 semanas

    Gasteiz / Vitoria, Álava, España Pharmiweb A tiempo completo

    Parexel is a leading biopharmaceutical services provider, dedicated to improving global health by transforming scientific discoveries into new treatments.We're seeking a highly skilled Clinical Research Associate II to join our Clinical Operations Team in Spain, working on a variety of clinical trials across different therapeutic areas.In this role, you'll...

  • Clinical Research Associate II

    hace 1 mes

    Gasteiz / Vitoria, Álava, España Pharmiweb A tiempo completo

    Job SummaryAs a Clinical Research Associate II - Oncology Specialist at Pharmiweb, you will be responsible for site management and clinical monitoring of clinical studies in the oncology therapeutic area. You will work closely with our team to ensure the protection of subjects, data integrity, and compliance with regulatory requirements.Key...

  • Clinical Operations Specialist

    hace 4 semanas

    Gasteiz / Vitoria, Álava, España Pharmiweb A tiempo completo

    Job Summary:We are seeking a highly skilled Clinical Operations Specialist to join our team at Pharmiweb. As a Clinical Operations Specialist, you will play a critical role in supporting the clinical trial team at the global level, impacting the project's success.Key Responsibilities:Keeping up to date with all the changes and required knowledge on ICH GCP,...

  • Clinical Research Associate II

    hace 4 días

    Gasteiz / Vitoria, Álava, España Pharmiweb A tiempo completo

    About UsParexel is a global biopharmaceutical services company dedicated to improving the world's health. With a strong commitment to our values: Patients First, Quality, Respect, Empowerment & Accountability, we strive to make a meaningful difference in people's lives.Job OverviewWe are seeking a highly skilled Clinical Research Associate II to join our...

  • Sales and Marketing Specialist

    hace 4 días

    Gasteiz / Vitoria, Álava, España Applied Medical A tiempo completo

    About the RoleWe are seeking a highly skilled Sales and Marketing Specialist to join our team in Vizcaya, Burgos, and Palencia. As a Territory Manager, you will be responsible for engaging with clinical and administrative hospital staff, identifying key stakeholders, and managing relationships autonomously.

  • Senior Account Manager

    hace 4 semanas

    Gasteiz / Vitoria, Álava, España Ntt Global A tiempo completo

    About the RoleThe Senior Account Manager will be responsible for managing and growing relationships to drive expansion and renewals across all solution areas within assigned regional clients. This role requires a seasoned subject matter expert who can leverage the company's tools and methodologies to analyze the client's situation and business requirements....

  • Senior Biostatistical Consultant

    hace 4 semanas

    Gasteiz / Vitoria, Álava, España Pharmiweb A tiempo completo

    Senior Biostatistical ConsultantWe are seeking a highly skilled Senior Biostatistical Consultant to join our team at Syneos Health. As a key member of our biostatistics department, you will be responsible for leading multiple projects and programs of studies, providing statistical expertise, and mentoring biostatisticians on job skills.Key...

  • Senior Technical Product Manager

    hace 4 semanas

    Gasteiz / Vitoria, Álava, España Renewable Energy Grid Solutions A tiempo completo

    Job Title: Senior Technical Product ManagerJob Summary: We are seeking a highly skilled Senior Technical Product Manager to lead the development and maintenance of our suite of intranet applications for electronics manufacturing plants. The ideal candidate will have a strong background in ASP.NET, Oracle DB, Windows Server, IIS technologies, and SAP, with...

  • Senior Manager Sales Marine

    hace 7 días

    Gasteiz / Vitoria, Álava, España Regal Rexnord A tiempo completo

    Job Title: Senior Manager Sales MarineRegal Rexnord is seeking a highly skilled Senior Manager Sales Marine to lead our sales efforts in the marine industry. As a key member of our sales team, you will be responsible for developing and executing sales strategies to drive growth and revenue in this critical market.Key Responsibilities:Develop and execute...

  • Senior Project Manager

    hace 4 semanas

    Gasteiz / Vitoria, Álava, España AEG Power Solutions A tiempo completo

    AEG Power Solutions is seeking a skilled Senior Project Manager to lead the coordination of assigned power systems projects. As the primary point of contact, you will ensure that projects are delivered in line with defined project performance measures.Main ResponsibilitiesManage project realization and coordination, ensuring timely delivery,...