Clinical Trial Manager Ii

hace 1 día

Colombia Huila Syneos Health Clinical A tiempo completo

**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 the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason - we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.

**Why Syneos Health**
- #SyneosHealthLife means we’re committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
- We believe our success is a direct result of the people who are driving it - you We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

**Job responsibilities**
- Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
- Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities.
- May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).
- Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CeMs) is aware of the contractual obligations and parameters.
- Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables.
- Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope.
- Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
- Participates and presents in key meetings such as Kick Off Meeting.
- Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. This may include accompanying CRA team members to sites for observation or conflict resolution.
- Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines. Reviews and provides feedback on other functional plans (eg. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities.
- Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed. Ensures access and audit trail reviews are conducted as required.
- Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study.
- Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality.
- Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools.
- Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan.
- Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan. Is accountab

  • Clinical Trial Manager with Global Experience

    hace 7 meses

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager any therapeutic area-Home based LATAM** 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 I

    hace 1 día

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **Clinical Trial Manager** 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 of. As a part of the Syneos Health team,...

  • Regulatory Lead with Clinical Trial Experience

    hace 1 semana

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **JOB TITLE: Regulatory Lead (RL)** **SELECT ONE: Clinical Solutions** **JOB CODE**:SH1739** **REPORTS TO: Manager, Site Start-Up & Regulatory; or designee** **JOB SUMMARY**: Performs assigned activities within the SSU Project Delivery Life Cycle Maintenance Team that support SSU activities as needed, for studies which have completed...

  • Clinical Trial Manager

    hace 3 meses

    Colombia, Huila ICON A tiempo completo

    As a Clinical Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. You will be partnering with a pharmaceutical company committed to discovering and developing treatments that improve and save people´s lives. Working in this program you will feel challenged and...

  • Senior Clinical Trial Manager, Oncology, Colombia

    hace 7 meses

    Colombia Novasyte A tiempo completo

    Required: 3+ years of Clinical Trial Management experience (CRO experience preferred). Experience managing clinical trials in LATAM and North America required Oncology experience related to managing studies Fluent in English, both writing and verbally Preferred: Experience managing global studies Experience managing studies in other therapeutic areas...

  • Ssu & Regulatory Specialist Ii/ Colombia Client

    hace 7 meses

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **Site Start-Up & Regulatory Specialist 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...

  • Ssu & Regulatory Specialist - Level I & Ii (Cro

    hace 44 minutos

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **JOB SUMMARY**: Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials. Responsible for the delivery, with oversight from the SSU Country Manager in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, and of...

  • Sr Clinical Project Manager in Latam

    hace 1 día

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **Senior Project Manager** 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 of. As a part of the Syneos Health team,...

  • Cra Ii or Sr Cra Bogota- Colombia

    hace 7 meses

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **Clinical Research Associate II or SR CRA - Colombia Client Based** **Bogota** 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...

  • Sr Site Contracts Specialist with Experience in

    hace 6 días

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **JOB TITLE: Senior Site Contracts Specialist** **SELECT ONE: Clinical Solutions** **JOB CODE**:SH2317** **JOB FAMILY: Clinical Operations** *** **BUSINESS UNIT** **(COMMERCIAL ONLY)**: **REPORTS TO**:Manager, SSU & Regulatory; or designee** **JOB SUMMARY**: **JOB RESPONSIBILITIES**: - May lead multi-country projects including...

  • Clinical Project Manager All Levels in Latam

    hace 5 días

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **Clinical Project Manager all levels in LATAM (Home Based)** 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 Project Specialist

    hace 6 días

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **Clinical Project Specialist - Fluent English - Home Based LATAM (Argentina, Brazil, Colombia, Mexico, Peru or Chile)** **Great opportunity for Clinical Trial Assistant** Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means...

  • Sr Cra

    hace 1 semana

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **enior Clinical Research Associate 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...

  • Clinical Project Specialist

    hace 6 días

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **Project Specialist** 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...

  • Sr Project Manager

    hace 3 días

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **Senior Project Manager** 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...

  • Regulatory Consultant with Clinical Trial Experience

    hace 7 meses

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **JOB TITLE: Regulatory Consultant** **JOB CODE: SH1837** **BUSINESS TITLE: Regulatory Consultant** **BUSINESS UNIT: Global Regulatory Affairs Solutions (GRAS)** **REPORTS TO: Director/Associate Director/Manager, GRAS or designee** **JOB SUMMARY** Provide regulatory and technical support for assigned product development projects,...

  • Cda Ii

    hace 7 días

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **Clinical Data Associate 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...

  • Cda Ii

    hace 1 día

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **Clinical Data Associate 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 the world and build the career you’ve dreamed of. As a part of the Syneos Health...

  • Cra All Levels Bogota- Colombia

    hace 7 meses

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **Clinical Research Associate II or SR CRA - Colombia Client Based** 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. Come discover what our...

  • Statistical Programmer Ii

    hace 7 meses

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **Statistical Programmer 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...