Clinical Trial Associate Ii

hace 1 mes

Madrid, España Ora A tiempo completo

**POSITION TITLE**: Clinical Trial Associate II

**DEPARTMENT**:Ora Europe

**LOCATION**: Remote, Spain

**Ora Values the Daily Practice of **
- Prioritizing Kindness
- Operational Excellence
- Cultivating Joy
- Scientific Rigor_

At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects.** **Today, our team continues to expand across the globe, with over 600 employees across North America, Europe, Asia, and Latin America.

**The Role**:
Ora's Clinical Trial Associate II (CTA II) assists Project Managers in clinical study conduct for clinical ophthalmic projects in posterior, anterior, and med device. They support the oversight feasibility including but not limited to, working with sites to generate contracts and budgets, collecting regulatory documents, and scheduling follow up patient visits of all clinical sites and ensures compliance with (GCP) protocol along with overall clinical objectives. Ora's CTA II's participate in all phases of clinical studies including start up, study maintenance, and close-out activities in addition to performing additional day to day activities under the guidance of the Sr. CTA/Lead, Assistant Project Managers and Project Managers and liaise between field and office and are expected to work more autonomously and independently than the CTA I.

**What You'll Do**:

- Ensure study documentation, communication, training and data collection is aligned with study protocol adherence, and all applicable SOPs, regulations and guidelines.
- Lead the development of assigned study-related documents (e.g., informed consent, source documents, study logs, etc.).
- Participate in all phases of clinical trial site management from study start-up, through study conduct and completing closeout activities.
- Collect and review site regulatory documents for accuracy and completion (1572, Financial Disclosure documents, CLIA waivers, etc.).
- Prepare essential documents package to support investigational product release for study and site approval as well as applicable study and site continuity report submissions and close-out submissions.
- Create regulatory packages for IRB/IEC study and site submission, as well as applicable continuity report, and close-out submissions.
- May assemble and distribute regulatory binders to clinical sites and provide monitors with Investigator Site File tracker in support of monitoring visits.
- Support project management activities including providing meeting minutes/agendas and weekly newsletter to the clinical team, as well as maintaining the clinical study tracking systems.
- Assist project managers in preparing study reports and collecting site status updates and study metrics.
- QC Trial Master File (for clinical projects where individual is not setting up and maintaining the file).
- Participate in Study Operations planning, Risk Assessment discussions, and Pre-Study Meetings.
- Provide support to Clinical Operations for implementing process improvement actions, performing bi-annual reviews of applicable SOPs, and conducting departmental training sessions.
- Assist with Sponsor/IRB/IEC audit preparations and participate in response to audit findings.
- Travel Requirements less than 10%
- Adhere to all aspects of Ora's quality system.
- Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora's data integrity & business ethics and regulatory requirements. Clear and sustained demonstration of Ora's values
- prioritizing kindness, operational excellence, cultivating joy and scientific rigor - as well as their linked behaviors.
- Responsibilities may differ from the above based on the specific needs of the business.

**What We Look For**:

- _Experience needed for the Role: _
- Bachelor's degree and a minimum of 1-year experience in clinical trials associate. Years of experience may be considered in lieu of degree.
- _Additional Skills & Attributes:_
- Ophthalmic experience is strongly preferred.
- Ability to work both alone as well as in a semi-virtual, cross-functional team environment.
- Knowledge of GCP/ICH regulations.
- Experience maintaining electronic trial master files.
- Excellent verbal and written communication skills.
- Exceptional organizational and time management skills in order to manage multiple trials, critical tasks and departmental process improvement efforts.
- Ability to remotely problem-solve with members of site staff.
- _Competencies and Personal Traits:_
- **What We Do**:

- **Execution Excellence**:

  • Clinical Trial Manager Ii

    hace 5 horas

    Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager II, Real World & Late phase studies** 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...

  • Clinical Trial Manager Ii

    hace 4 meses

    Madrid, España Caidya A tiempo completo

    **Job Title: Clinical Trial Manager II (CTM II**)**Job Location**:Spain - Madrid (Home-based position, any mainland location in Spain considered)** **Job Overview**: The Clinical Trial Manager II is responsible for the day to day leadership and management of monitoring services for clinical projects, including direct communication and interaction with...

  • Global Clinical Trial Manager Ii

    hace 7 meses

    Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager II** 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...

  • Sponsor Dedicated Clinical Trial Manager Ii

    hace 7 meses

    Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Sponsor Dedicated Clinical Trial Manager II / Sr CTM - Home Based in SPAIN** Experience in the management of **global/multi-country** 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...

  • Clinical Trial Manager Ii. Madrid. Sponsor

    hace 6 meses

    Madrid, España Syneos - Clinical and Corporate - Prod 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...

  • Sponsor Dedicated Clinical Trial Manager Ii/ Sr

    hace 7 meses

    Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Sponsor dedicated Clinical Trial Manager II/ Sr CTM - Home Based in Spain** Experience in the management of **global/multi-country** studies and different types of vendors is required. Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product...

  • Clinical Trial Associate Ii

    hace 7 meses

    Madrid, España Allucent A tiempo completo

    Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory...

  • Sponsor Dedicated Clinical Trial Manager Ii/ Sr Ctm

    hace 7 meses

    Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Sponsor Dedicated Clinical Trial Manager II/ Sr CTM - Home Based in SPAIN** Experience in the management of global/multi-country 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 clinical,...

  • Clinical Trial Manager Ii. Madrid. Sponsor Dedicated

    hace 3 semanas

    Madrid, España Syneos - Clinical and Corporate - Prod 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...

  • Sponsor Dedicated Local Clinical Trial Manager Ii

    hace 2 meses

    Madrid, España Syneos - Clinical and Corporate - Prod A tiempo completo

    **Description** **Sponsor Dedicated Local Clinical Trial Manager II - Neurology // Home Based Spain** Neurology experience is required. 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...

  • Sponsor Dedicated Clinical Trial Manager Ii/ Sr Ctm

    hace 5 horas

    Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Sponsor Dedicated Clinical Trial Manager II/ Sr CTM - Home Based Spain** Experience in the management of global/multi-country studies is required Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly...

  • Clinical Trial Specialist

    hace 1 semana

    Madrid, Madrid, España Ora A tiempo completo

    OverviewOra is a leading full-service ophthalmic drug and device development firm, guiding clients across all phases of clinical research to efficiently bring new products and therapies to market.About the RoleThe Clinical Trial Associate II (CTA II) assists Project Managers in clinical study conduct for ophthalmic projects. Responsibilities include...

  • Clinical Trial Associate

    hace 1 mes

    Madrid, España buscojobs España A tiempo completo

    At TFS HealthScience, we are dedicated to advancing clinical research through innovative solutions and a commitment to quality. We provide tailored services across the clinical development lifecycle to deliver impactful results for our clients and the healthcare industry.Role Overview :We are looking for a Clinical Trial Associate to support TMF archiving...

  • Clinical Trial Associate

    hace 1 mes

    Madrid, España buscojobs España A tiempo completo

    At TFS HealthScience, we are dedicated to advancing clinical research through innovative solutions and a commitment to quality. We provide tailored services across the clinical development lifecycle to deliver impactful results for our clients and the healthcare industry. Role Overview : We are looking for a Clinical Trial Associate to support TMF archiving...

  • Clinical Trial Associate

    hace 2 semanas

    Madrid, España TFS HealthScience A tiempo completo

    At TFS HealthScience, we are dedicated to advancing clinical research through innovative solutions and a commitment to quality. We provide tailored services across the clinical development lifecycle to deliver impactful results for our clients and the healthcare industry.Role Overview:We are looking for a Clinical Trial Associate to support TMF archiving and...

  • Clinical Research Associate II

    hace 3 semanas

    Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completo

    Accelerate the Delivery of TherapiesSyneos Health, a leading biopharmaceutical solutions organization, is seeking a Clinical Research Associate II to join our team. $85,000 - $110,000 per year, depending on location and experience.Company OverviewWe translate clinical, medical affairs, and commercial insights into outcomes to address modern market realities....

  • Clinical Trial Manager Ii

    hace 1 mes

    Madrid, España Engineeringuk A tiempo completo

    .As a Local Trial Manager, you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.The LTM is the primary point of contact at a country level for assigned studies. The LTM is responsible for coordinating and leading the local trial team in order to deliver quality data and trial...

  • Clinical Trial Manager

    hace 2 días

    Madrid, España Worldwide Clinical Trials A tiempo completo

    **Requisition Number** **6115** **Employment Type***: **Regular** **Who we are** We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with...

  • Clinical Research Associate II

    hace 6 días

    Madrid, Madrid, España Syneos Health, Inc. A tiempo completo

    About the Role We are seeking a highly motivated and detail-oriented Clinical Research Associate II to join our team at Syneos Health, Inc. in Madrid, Spain. This is an excellent opportunity for a professional looking to advance their career in clinical research.Job Responsibilities As a Clinical Research Associate II, you will be responsible for performing...

  • Clinical Trial Coordinator

    hace 3 semanas

    Madrid, Madrid, España Iqvia A tiempo completo

    Career Opportunity at IqviaJob OverviewThe Study Administrator is responsible for coordinating and administering daily study activities to ensure timely and accurate delivery of the Trial Master File. Working closely with the Clinical Research Associates and Regulatory and Start-Up teams, this role ensures quality and consistency in study deliverables.Key...