Clinical Trial Manager Ii

hace 3 días


En remoto, España ICON A tiempo completo

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Trial Manager in FSE manages assigned clinical trials, leads the FSE trial teams in order to ensure high quality execution of the trials and deliverables within all countries in the FSE. TM enables the Adjacent

Affiliate teams to deliver clinical trials in the shortest possible time in accordance with the Client policies and procedures, SOP’s, local legislation and GCP requirements.
- Overall project management of assigned clinical trials in the FSE and adjacent affiliates
- Responsible for deliverables and high-quality execution of clinical trials in the FSE and adjacent

affiliates
- Leading the FSE trial teams
- Planning, executing, coordinating tasks and communicating between relevant roles, such as FSE CTA

and CRAs in adjacent affiliates and global trial management, to facilitate the progress of the trial
- Attending all trial related meetings / TCs and ensuring knowledge sharing across the FSE trial team
- Proactive risk identification and executing mitigation plans at the FSE level and adjacent affiliates
- Ensuring successful start-up of clinical activities in the FSE and adjacent affiliates (all trial related

documents review, CTA dossier oversight, ensure timely HA/EC submission/approval, ensure
- Responsible for trial budgets (ClinCost): preparation and tracking in the FSE and adjacent affiliates
- Execute and follow up on Recruitment and Retention plans at the FSE level and adjacent affiliates
- Perform Visit Report review (all type of visits)
- Conduct co-monitoring visits across the FSE
- CTMS set-up & update at country level (for adjacent affiliates)
- Oversight and compliance check of STMF (nD/Veeva) for assigned clinical trials in close collaboration
- Supervise clinical supplies’ processes in the FSE and adjacent affiliates, e.g. ordering, handling

ancillary, import-export process
- Report timely on quality issues
- Audit readiness, audit action plans and follow up for assigned clinical trials in FSE
- Inspection readiness and inspection action plan for assigned clinical trials in FSE

Knowledge
- Working knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP)and applicable international regulations and guidelines
- Clinical Development process and procedures
- Project planning experience including oversight of study deliverables, budgets, and timelines
- Experience anticipating and resolving problems
- Experience writing and presenting clearly on scientific and clinical issues
- Experience collaborating and leading cross-functional teams (team/matrix environment)
- Knowledge of project risk management assessment and mitigation approaches
- Proven experience of successful collaboration in multi-national environment
- Proven decision making and problem-solving capabilities

Key competencies
- Project Management
- Risk assessment
- Critical Thinking and Planning
- Matrix Team organization/leadership
- Metrics analysis
- Written and oral communication
- Delivery focus
- Relationship management
- Conflict resolution
- Adaptability and Flexibility
- Working in virtual teams
- Ability to work in changing environment to be agile and proactively finding efficient ways of doing things
- Excellent communication skills - ability to communicate and build relationships with various stakeholders
- Team oriented personality with high degree of flexibility and cross-cultural awareness Presentation and negotiation skills

Education requirements
- BA/BS/BSc or RN, with Master level of education preferred
- Fluency in English - written and spoken
- Minimum 5 years of experience in operational aspects of planning and conducting clinical trials
- Minimum 1 year (preferably 2 years) of experience in project management of clinical trials at regional level (e.g. multi country set-up)

**Benefits of Working in ICON**:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits



  • En remoto, España Parexel A tiempo completo

    Parexel are currently recruiting for an experienced Oncology Associate Clinical Trial Manager. In this position you will be the individual responsible for the coordination of clinical operations required to initiate, execute and complete clinical trials to drive on-time delivery of clinical trial milestones. May act in support or lead role **Some specifics...


  • En remoto, España ICON A tiempo completo

    ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development...

  • Clinical Trial Leader

    hace 7 meses


    En remoto, España Parexel A tiempo completo

    Spain, Remote **Job ID** R0000019423 **Category** Clinical Trials **ABOUT THIS ROLE**: **Role Purpose** The CTL provides leadership and direction to the trial team and is accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and KPI’s. They are responsible for steering and directing clinical...


  • En remoto, España Allucent A tiempo completo

    These customers have new therapeutic ideas, but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in...


  • En remoto, España Parexel A tiempo completo

    The **Initiation Clinical Research Associate II **(**iCRA II**) specialises in performing all study start up activities for a clinical trial. You will participate in Pre SIV activities and be assigned & accountable for managing and driving the strategy for the Pre SIV / start up tasks of the study. The iCRA II can also support protocol amendments if...

  • Clinical Trial Manager

    hace 2 días


    En remoto, España ICON A tiempo completo

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...

  • Clinical Lead Ii/iii

    hace 7 meses


    En remoto, España Premier Research A tiempo completo

    At **Premier Research,** we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for...


  • En remoto, España Parexel A tiempo completo

    Additional Job Description The **Initiation Clinical Research Associate II **(**iCRA II**) specialises in performing all study start up activities for a clinical trial. You will participate in Pre SIV activities and be assigned & accountable for managing and driving the strategy for the Pre SIV / start up tasks of the study. The iCRA II can also support...


  • En remoto, España Allucent A tiempo completo

    These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities. You’ll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you’ll help make a positive difference in...


  • En remoto, España Expert Clinical Trials A tiempo completo

    **Job summary**: As an experienced **Clinical Research Associate **you will be expected to actively participate in and manage the recruitment of potential investigators and perform CA and EC submissions. You will be responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, liaison with vendors and...

  • Cra Ii

    hace 7 meses


    En remoto, España ICON A tiempo completo

    ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. As a Clinical Research Associate you will be joining the world’s largest & most comprehensive...

  • Senior Project Manager

    hace 7 meses


    En remoto, España ICON A tiempo completo

    As a Clinical Project Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **We are looking for experienced Project Managers with substantial experience in multi-country/global PM experience.** **What you will be doing**: - The Study Manager has responsibility 1 or more...


  • En remoto, España OPIS s.r.l. A tiempo completo

    Founded in 1998 in Italy and now operating at an international level, OPIS is a full-service science driven biotech focused CRO providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects. OPIS added...

  • Project Manager Ii

    hace 6 meses


    En remoto, España Premier Research A tiempo completo

    Premier Research is looking for a** Project Manager II** to join our** Oncology **team. You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the...


  • En remoto, España Premier Research A tiempo completo

    At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all....


  • En remoto, España ICON A tiempo completo

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...


  • En remoto, España AL Solutions A tiempo completo

    Chloe O'Shea has partnered with a small and unique CRO based in US and now they are looking to expand into Europe! This is a fantastic opportunity for a confident Clinical Operations Manager who can work well independently. You will be the first Clinical Operations Manager in Europe leading the CRAs & CTAs independently, reporting directly to the Director of...


  • En remoto, España Premier Research A tiempo completo

    At Premier Research, we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for all....


  • En remoto, España ICON A tiempo completo

    As a Senior Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing**: - You will monitor multiple Phase I, II, III & IV clinical trial sites, across different therapeutic areas. Assist other CRAs with co-monitoring activities...


  • En remoto, España ICON A tiempo completo

    ICON has an exciting new opportunity for a Global Project Manager to join a growing and successful team. This is a home-based and permanent role. Key Responsibilities: Responsible for: - Lead the development of realistic study timelines, from design through final study reporting Maintaining accuracy of clinical study timeline information in data control...