Senior Clinical Research Manager

1 dzień temu

Warszawa, Mazovia, Polska Allucent Pełny etat
About the Role

We are seeking a highly experienced and skilled Clinical Trials Manager to join our team at Allucent. As a Clinical Trials Manager, you will be responsible for providing leadership and management to the Clinical Research Associates and other clinical functional groups, in their day-to-day clinical trial activities.

Key Responsibilities
  • Manage the study start-up process, including coordination with the Project Manager, Regulatory Lead, and Global Site Activation Manager.
  • Coordinate and oversee critical documentation collection, maintenance, and filing.
  • Prepare monitoring plans, provide input to TMF plans, and ensure all plans are implemented.
  • Contribute to the development of CRF guidelines and edit checks.
  • Customize site visit report checklists and templates according to study-specific requirements.
  • Develop or modify templates for monitoring activities according to study requirements.
  • Select investigators and sites, review and approve SEV reports.
  • Manage site initiation, review and approve SIV reports.
  • Review, manage, resolve, and escalate monitoring visit reports.
  • Manage successful trial close-out, identify critical activities for timely and efficient close-out.
  • Responsible for timelines, budget, and quality of Clinical Monitoring team deliverables, identification of risks and issues, and escalation to the Project Manager, Line Manager, and CRMs/COMs.
  • Coordinate and manage site visit schedules.
  • Manage CRA site assignments and schedules.
  • Develop patient recruitment and retention plans.
  • Provide information and input about planned activities to the Project Manager for regular Project Review Meetings and attend Project Review Meetings if needed.
  • Conduct project co-monitoring (if required) and team training.
  • Site contact for protocol clarifications and subject enrollment if CRA unavailable.
  • Monitor and manage trial materials supplies, ensuring Investigational Product and other study supplies are shipped to sites.
  • Review data listings and query reports to identify trends and ensure proactive re-training is conducted with CRAs and site staff.
  • Oversee the process of protocol deviation documentation, tracking, and escalation.
  • Participate in the development of study newsletters communication.
  • Relay project status and issues to the Project Manager.
  • Request through the Project Manager appropriate Clinical Operations staffing, workload, and resources and report study deliverables and resource needs.
  • Assist, where appropriate, the Project Manager in discussions with clients on study documentation issues or technical-related documentation concerns that may arise.
  • Review study systems (CTMS, CRF, IRS, central lab portal, etc.) updates on a regular basis, ensure systems reports are up to date, and reports generated are current and correct.
  • Coach/mentor CRA team.
  • Develop and deliver project-specific training and provide input to Project Specific Training Matrix.
  • Ensure project consistency within and across projects by following SOPs.
  • Assist and support in the preparation of study-specific training matrix and various training material (including SOPs training, as well as specific-therapeutic area-related). Assist and support web-based training material preparation. Assist when needed in the preparation of company and scientific/medical presentations to potential clients and at Investigators' meetings and other committees' meetings as requested.
  • Assist in revision of Site Budgets and manage Investigator and Site Payments.
  • Contribute to case management and timely closure.
  • Support the Project Manager in the management of study vendors as required.
  • Provide input into proposals when required.
  • Actively participate in preparation, attendance, and presentation of bid defense or any other study-related meetings.
Requirements

To be successful, you will possess:

  • A bachelor's degree in life sciences or nursing qualification preferred.
  • A minimum of 6 years of clinical research experience with at least 2 years of Clinical Trials Manager or Clinical Trials Monitor experience.
  • Ability to mentor and train other CRAs in a positive and effective manner.
  • In-depth knowledge of clinical trials and the critical elements for success in clinical trials.
  • Strong therapeutic background.
  • Possesses experience and knowledge in the CRO industry that will support management of clinical trials.
  • Demonstrates the ability to successfully manage people/project issues.
  • Mature management skills demonstrated by calm and thorough review of situations. Proactively identifies and addresses problems. Seeks to understand all contributing factors. Proposes, implements, and evaluates appropriate resolutions.
  • Demonstrates the ability to define and meet project requirements.
  • Demonstrates flexibility for improvement and creating solutions.
  • Proven organizational abilities, and excellent written and oral communication skills.
  • Excellent team player with team building skills.
  • Strong customer focus.

  • Senior Clinical Project Manager

    1 dzień temu

    Warszawa, Mazovia, Polska Innovaderm Research Pełny etat

    About the RoleWe are seeking an experienced Senior Project Manager to join our team at Innovaderm Research. As a Senior Project Manager, you will be responsible for leading clinical trials from start to finish, ensuring timely and within-budget delivery of projects.Key ResponsibilitiesLead clinical trials from start to finish, ensuring timely and...

  • Clinical Research Coordinator

    1 dzień temu

    Warszawa, Mazovia, Polska Innovaderm Research Pełny etat

    About the RoleWe are seeking a highly organized and detail-oriented Project Coordinator to join our team at Innovaderm Research. As a Project Coordinator, you will play a critical role in supporting the successful execution of clinical trials.Key ResponsibilitiesPrepare Investigator Sites for clinical trials by reviewing and approving essential...

  • Clinical Trial Manager EU

    1 dzień temu

    Warszawa, Mazovia, Polska Innovaderm Research Pełny etat

    Clinical Trial Manager EU Job DescriptionWe are seeking a highly skilled Clinical Trial Manager to join our team at Innovaderm Research in Poland, Spain, or Germany. As a Clinical Trial Manager, you will be responsible for the operational management and oversight of clinical investigative sites, as well as clinical monitoring deliverables of clinical...

  • Clinical Trials Project Manager

    1 dzień temu

    Warszawa, Mazovia, Polska Innovaderm Research Pełny etat

    About the RoleWe are seeking an experienced Project Manager to join our team at Innovaderm Research. As a Project Manager, you will be responsible for leading clinical trials from start to finish, ensuring timely and within-budget delivery of projects.Key ResponsibilitiesLead client interactions, providing efficient and timely updates on trial...

  • Clinical Data Manager

    1 dzień temu

    Warszawa, Mazovia, Polska Worldwide Clinical Trials Pełny etat

    Join Our Team at Worldwide Clinical TrialsWe are a leading global contract research organization (CRO) that works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications.Our dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare diseases enables us to...

  • Clinical Research Manager

    1 dzień temu

    Warszawa, Mazovia, Polska CDS Fortrea Inc. Pełny etat

    Transform Clinical Trials with CDS Fortrea Inc.As a leading global contract research organization (CRO), CDS Fortrea Inc. 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...

  • Senior Project Coordinator

    1 dzień temu

    Warszawa, Mazovia, Polska Innovaderm Research Pełny etat

    About the RoleWe are seeking a highly skilled and experienced Senior Project Coordinator to join our team at Innovaderm Research. As a Senior Project Coordinator, you will play a key role in the management of clinical trials and site activation activities.Key ResponsibilitiesPrepare Investigator Sites to conduct clinical trials through the review and...

  • Clinical Research Associate

    1 dzień temu

    Warszawa, Mazovia, Polska Novo Nordisk Pełny etat

    Job Title: Clinical Research AssociateAs a Clinical Research Associate at Novo Nordisk, you will play a crucial role in ensuring the accuracy and completeness of trial data, protecting the rights and well-being of human subjects, and ensuring the conduct of trials follows approved protocols, GCP, and local legislations.Main Responsibilities:Perform site...

  • Clinical Systems Specialist

    1 dzień temu

    Warszawa, Mazovia, Polska Innovaderm Research Pełny etat

    Job Title: Clinical System SpecialistWe are seeking a highly skilled Clinical System Specialist to join our team at Innovaderm Research. As a key member of our IT department, you will be responsible for providing technical support and training to our internal end users for the Clinical Trial Management System.Key Responsibilities:Manage and support the...

  • Senior Clinical Research Associate

    1 dzień temu

    Warszawa, Mazovia, Polska IQVIA Pełny etat

    Are you passionate about collaborating with leading pharma companies to make a difference in patients' lives worldwide?As a sponsor-dedicated Senior Clinical Research Associate at IQVIA, you'll enjoy the stability and resources of a global contract research organization while gaining direct experience with one of our clients. This role promises to offer...

  • Clinical Research Associate

    1 dzień temu

    Warszawa, Mazovia, Polska AbbVie Pełny etat

    Job Title: Clinical Research AssociateJob Summary:We are seeking a highly motivated and detail-oriented Clinical Research Associate to join our team at AbbVie. As a Clinical Research Associate, you will be responsible for monitoring clinical trials, ensuring compliance with regulations and guidelines, and providing support to investigators and study...

  • Clinical Research Associate II

    1 dzień temu

    Warszawa, Mazovia, Polska PSI CRO Pełny etat

    Job Title: Clinical Research Associate IIAt PSI CRO, we are seeking a highly skilled Clinical Research Associate II to join our team. As a Clinical Research Associate II, you will play a crucial role in improving patients' lives while enjoying a variety of monitoring tasks and working on clinical studies in different therapeutic indications.Key...

  • Clinical Research Associate

    1 dzień temu

    Warszawa, Mazovia, Polska IQVIA Pełny etat

    Job OverviewManage Clinical Studies from Initiation to CloseoutAs a Centralized Monitor, you will be responsible for ensuring the execution of assigned clinical studies is on time and in accordance with standard operating procedures (SOPs), policies, and practices. You will provide project-related support and assistance across multiple projects, sites, and...

  • Clinical Research Associate Assistant

    1 dzień temu

    Warszawa, Mazovia, Polska Thermo Fisher Scientific Pełny etat

    Job Title: Clinical Research Associate AssistantAt Thermo Fisher Scientific, we are committed to enabling our customers to make the world healthier, cleaner, and safer. As a Clinical Research Associate Assistant, you will play a critical role in supporting our clinical operations team in delivering high-quality clinical trials.Job Summary:The Clinical...

  • Clinical Data Manager Specialist

    9 godzin temu

    Warszawa, Mazovia, Polska Worldwide Clinical Trials Pełny etat

    About UsWorldwide Clinical Trials is a leading global contract research organization (CRO) that partners with biotechnology and pharmaceutical companies to develop customized solutions for advancing new medications.Our MissionWe apply our scientific heritage and dedicated therapeutic focus on cardiovascular, metabolic, neuroscience, oncology, and rare...

  • Clinical Medical Manager

    1 dzień temu

    Warszawa, Mazovia, Polska Novo Nordisk Pełny etat

    Job Title: Clinical Medical ManagerWe are seeking a highly skilled Clinical Medical Manager to join our team at Novo Nordisk. As a Clinical Medical Manager, you will play a critical role in facilitating the execution of clinical trials related to New Therapy Areas, including Cardiovascular, CKD, Liver Diseases, and Alzheimer's diseases.Key...

  • Associate Project Manager

    1 dzień temu

    Warszawa, Mazovia, Polska Innovaderm Research Pełny etat

    About the RoleWe are seeking an experienced Associate Project Manager to join our team at Innovaderm Research. As an Associate Project Manager, you will play a key role in the successful initiation, planning, execution, monitoring, controlling, and closure of assigned clinical research projects.Key ResponsibilitiesEnsure compliance with study budget, project...

  • Clinical Research Associate II

    1 dzień temu

    Warszawa, Mazovia, Polska PSI Pełny etat

    Job Title: Clinical Research Associate IIAbout the Role:We are seeking a highly motivated and experienced Clinical Research Associate II to join our team at PSI. As a CRA, you will play a critical role in the success of our clinical studies, working closely with our site management team to ensure the highest quality standards are met.Key...

  • Senior Statistical Programmer Lead

    1 dzień temu

    Warszawa, Mazovia, Polska Innovaderm Research Pełny etat

    Job Title: Senior Statistical ProgrammerWe are seeking a highly skilled Senior Statistical Programmer to join our team at Innovaderm Research. As a Senior Statistical Programmer, you will play a key role in leading single and/or multiple clinical trials, developing, maintaining, and validating annotated Case Report Forms (aCRFs), as well as specifications...

  • Senior Project Coordinator

    9 godzin temu

    Warszawa, Mazovia, Polska Innovaderm Research Pełny etat

    About the RoleWe are seeking a highly organized and detail-oriented Senior Project Coordinator to join our team at Innovaderm Research. As a key member of our Site Activation and Project Coordination department, you will play a critical role in ensuring the successful start-up and management of clinical trials.Key ResponsibilitiesPrepare Investigator Sites...