Clinical Trial Manager Ii

hace 5 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 investigative sites, Clinical Research Associates (CRAs), and the project Sponsor. This position ensures the on time and high quality delivery of: project specific on-site and remote monitoring services; accountability for clinical monitoring team training compliance; tracking of critical project tasks; strategic and tactical study enrollment support including, project-specific enrollment planning; and project accountability for CRA utilization.

**Job Duties and Responsibilities**:

- Ensure project consistency within and across assigned projects by following Caidya and/or sponsor SOPs, guidelines, and plan documents.
- Create and manage the Clinical Monitoring Plan (CMP), including regular review (annual at minimum) and updates to the plan.
- Review and provide input to the Project Manager (PM) on the Project Management Plan (PMP).
- Timely CRA trip report review, management, resolution, and escalation. Includes tracking of trip report packet (confirmation letter, report, follow up letter) submissions.
- Timely review of protocol deviations, action items and frequently asked questions. Track and escalate items as appropriate.
- Oversee clinical portion of the Trial Master File (TMF) and conduct periodic review for completeness.
- Responsible for ongoing analysis of enrollment activities/trends and escalation/mitigation to PM/Sponsor as appropriate. Develops strategic and tactical plans for ensuring enrollment targets are met.
- Develop study newsletter.
- Responsible for project resource projections and ensure appropriate CRA staffing. Remove CRAs through planned attrition according to study timelines and budget projections.
- Responsible for assuring the quality of the clinical monitoring deliverables and for identifying and mitigating risks.
- Manage monitoring team site assignment and visit schedules to ensure CMP metrics are maintained.
- Oversee CRAs to complete remote site management activities.
- Conduct project co-monitoring visits and team training for assuring the quality of the clinical monitoring deliverables and for identifying and mitigating risks.
- Provide coaching/mentoring to the monitoring team.
- Develop project specific training materials for study team.
- Provide project-specific performance feedback to CRA team, PM, and Line Management.
- Conduct internal team calls and Sponsor calls (as needed).
- Serve as Sponsor contact for monitoring/site issues.
- Relate project status and issues to CRAs and PM weekly at minimum.
- Responsible for coordination and management of the clinical monitoring budget and scope of work for monitoring activities.
- Assist the PM with coordination and management of the project budget, grant administration and project invoicing.
- May review and approve weekly project labor and pass through expenses for CRAs.
- Track monitoring services billing units and report to Project Manager monthly.
- Make updates to study specific CTMS and/or project working files as appropriate.
- Participate in monthly project review meetings and provide budget projections for monitoring service units.
- Monitor and plan for resolution of data backlog by working with clinical management.
- Collaborate with Lead Data Manager to develop CRF Completion Guidelines and edit specifications.
- Deliver Clinical Monitoring portion of a bid defense presentation.
- Support in the development of working relationships with regulatory authority and IRB/IEC personnel within the constraints of any local guidelines and regulations.
- Attend project and department meetings.
- Complete weekly time and expense entry.
- Maintain good standing with internal training requirements.
- May assume CRA duties and responsibilities when needed.
- Conduct other activities as needed for a given project.

**Supervisory Responsibilities**:

- Provides project work direction to regional/office-based CRAs, Internal Clinical Research Associates (ICRAs), and CTAs.
- In some regions, may identify and hire CRAs/CTAs and/or provide direct line management.

**Job Requirements**:

- Education
- University degree desired, preferably with a healthcare or life science degree or equivalent experience
- Experience
- 4 + years of Clinical Research Associate (CRA) experience or equivalent preferred.
- 2-4 years of Clinical Trial Manager (CTM) experience or an equivalent combination of education and experience to successfully perform the key responsibilities of the role.
- Specific therapeutic experience may be required (e.g. infectious disease, oncology, etc.)
- In some regions, specific licensure may be required (e.g. Pharmacist, Registered Nurse, etc.)
- Skills/Competencies
- Stro

  • Clinical Trial Manager Ii

    hace 2 semanas

    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...

  • 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...

  • Clinical Trial Manager I-ii Madrid. Sponsor

    hace 2 semanas

    Madrid, España Syneos Health Clinical A tiempo completo

    **Clinical Trial Manager I-II Madrid. Sponsor dedicated.** **-** **(**22004074**)** **Description** **Clinical Trial Manager II** Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around...

  • 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 Homebased Spain

    hace 1 semana

    Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager II **SPAIN ** - Sponsor Dedicated** Come discover what our 25,000+ employees already know: **work here matters everywhere**. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed...

  • Clinical Trial Manager Ii. Madrid. Sponsor

    hace 7 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...

  • Sponsor Dedicated Clinical Trial Manager Ii

    hace 6 días

    Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Sponsor dedicated Clinical Trial Manager II / Sr CTM - Spain or UK Home-Based** **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...

  • 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,...

  • 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 2 semanas

    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 Manager Ii |

    hace 2 semanas

    Madrid, España Ares Consultores 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 Ii

    hace 2 meses

    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 Associate Ii

    hace 2 meses

    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...

  • Global Clinical Trial Manager Homebased Barcelona

    hace 7 días

    Madrid, España Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager II **BARCELONA ** - Sponsor Dedicated** Come discover what our 25,000+ employees already know: **work here matters everywhere**. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve...

  • Clinical Trial Associate Ii

    hace 7 días

    Madrid, España Ora A tiempo completo

    .Ubicación:Madrid, Madrid provinciaDescripción completa del empleo:POSITION TITLE: Clinical Trial Associate IIDEPARTMENT: Ora EuropeLOCATION: Remote, SpainOra Values the Daily Practice of ...Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific RigorAt Ora, we are building the future of ophthalmic clinical research. As the world's...

  • Clinical Trial Associate Ii Uqg168

    hace 7 días

    Madrid, España Ora A tiempo completo

    Ubicación: Madrid, Madrid provincia Descripción completa del empleo: 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...

  • Clinical Trial Associate Ii

    hace 7 días

    Madrid, España Ora A tiempo completo

    .Ubicación: Madrid, Madrid provincia Descripción completa del empleo: POSITION TITLE: Clinical Trial Associate IIDEPARTMENT: Ora EuropeLOCATION: 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...

  • Clinical Trial Associate Ii Uqg168

    hace 7 días

    Madrid, España Ora A tiempo completo

    Ubicación: Madrid, Madrid provinciaDescripción completa del empleo:POSITION TITLE: Clinical Trial Associate IIDEPARTMENT: Ora EuropeLOCATION: Remote, SpainOra Values the Daily Practice of ... Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific RigorAt Ora, we are building the future of ophthalmic clinical research.As the world's...

  • Clinical Trial Associate Ii Uqg168

    hace 7 días

    Madrid, España Ora A tiempo completo

    Ubicación: Madrid, Madrid provinciaDescripción completa del empleo:POSITION TITLE: Clinical Trial Associate IIDEPARTMENT: Ora EuropeLOCATION: Remote, SpainOra Values the Daily Practice of … Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific RigorAt Ora, we are building the future of ophthalmic clinical research.As the world's...