Regulatory Lead with Clinical Trial Experience

hace 3 semanas

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 site activation, in all phases of clinical trials related to investigational drugs, biologicals and medical devices as required.

**JOB RESPONSIBILITIES**:

- Provides oversight of all project SSU activities which encompasses all activities for life cycle maintenance amendment deliverables.
- Collaborates with all major functional area leads including (SSU Country Managers, Project Management, Clinical, Data Management and Medical Writing).
- Ensures all project deliverables meet the internal customers’ expectations and the contracted deliverables and any key performance indicators, providing accurate projections, quality of output, reports and updates, and ongoing risk assessments, as per manager’s instruction.
- Develops and maintains relationships with customers in alignment with their assigned projects. Ensures that individual project targets and client needs are met, services are provided with the highest quality standards, and policies and procedures are followed.
- Assumes accountability on SSU deliverables including, but not limited to:

- Life cycle maintenance amendment activities;
- Communication and coordination with country start
- up specialists for all RA, IEC/IRB submission deliverables;
- Overall SSU timelines for life cycle maintenance amendment activities;
- Communication and coordination with Site Contract Negotiator(s) for amendments to contracts and/or budget independent to the submission deliverables.
- Maintains plans in accordance with Standard Operating Procedures and/or sponsor-scoped processes. Complies all controlled document requirements and other requirements to ensure quality deliverables.
- Manages life cycle maintenance activities’ timelines and reports weekly progress including plans to address any potential timing risks/gaps and prepares and presents regulatory strategy and status at client meetings and communicates outcomes to project team.
- Ensures adequate monthly reporting through Executive Summaries or equivalent tools.
- Reviews the project budget for out of scope activities for life cycle maintenance activities in collaboration with Project Lead (PL) to ensure project profitability.
- In collaboration with the PL, reconciles revenue units completed and projects future units on a monthly basis.
- Uses corporate tools for planning and management of scope, timeline, and resources and ensures minimum hours are used for tasks. If out-of-scope work is requested, calculates the units required and notifies the PM.
- Performs a Regulatory Impact Assessment on core amendment submission documents and communicates any risk mitigation to Sponsor/Project teams and oversees review for Regulatory Impact Assessment for 2nd level to identify gaps, highlights any risk management to Sponsor/Project teams.
- Liaises with the appropriate stakeholders to request resources for project activities. Ensures systems are accurately populated and highlights to the country managers if allocation is insufficient.
- Accountable for the timely follow-up for Ethics Committee/Regulatory Authority enquiries or objections in collaboration with the country start up
- specialists. Meets or expedites the planned submission/approval timelines; if forecasted timelines are not reached or if any potential issue is identified, pro-actively solves or escalates the problem quickly.
- Oversees the timely provision for filing of submission documents to the study’s Trial Master File in collaboration with the country start-up specialist.
- Ensures timely and accurate filing of documents owned by their role.
- Identifies best practices and participates in process improvement initiatives in conjunction with the global SSU leadership plan and project deliverables.
- Provides life cycle maintenance specific training and mentoring to junior teams and/or new starters.
- Reviews study transitions with a focus on quality and efficiency with the support of their line manager or designee.

**Qualifications**

**QUALIFICATION & REQUIREMENTS (please indicate if ‘preferred’)**
- Bachelor’s Degree.
- Minimum 3 years CRO industry experience and/or a minimum 3 years’ experience working in SSU.
- Detailed understanding of clinical trial process across Phases II-IV and ICH GCP.
- Ability to understand clinical protocols and associated study specifications.
- Detailed understanding of clinical trial start-up processes.
- Ability to interact effectively and appropriately with Sponsors and study teams.
- Strong organizational skills with ability to handle multiple tasks effectively.
- Strong written and verbal communication and interpersonal skills.
- Ability to manage

  • 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,...

  • Clinical Trial Specialist

    hace 3 días

    Colombia Barrington James A tiempo completo

    Company OverviewBarrington James is a leading recruitment agency specializing in clinical operations consultants. Our client, a Spanish-based CRO company, requires a skilled Clinical Research Associate to oversee clinical trials in Colombia.Job DescriptionThe ideal candidate will be responsible for ensuring clinical trials comply with protocols, regulatory...

  • Sr Site Contracts Specialist with Experience in

    hace 2 semanas

    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 Trial Coordinator

    hace 4 días

    Colombia MSD A tiempo completo

    Clinical Trial Coordinator. Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as...

  • 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...

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

    hace 1 semana

    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 Cra I with Oncology Experience

    hace 7 meses

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **Senior Clinical Research Associate I with oncology experience - Home Based Colombia** 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...

  • Contract Clinical Research Associate

    hace 2 semanas

    Colombia Barrington James A tiempo completo

    Get AI-powered advice on this job and more exclusive features. Recruitment Consultant - Specializing Clinical Operations Consultants - North & South America My Client is a Spanish based CRO company who are looking for a 20 hours a month contractor starting with a 12 month contract with highly likely of extension. CRA - 7+ years Colombia Regulatory...

  • Sr Clinical Data Scientist

    hace 5 horas

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** 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 customers achieve their...

  • 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...

  • Clinical Project Specialist

    hace 2 semanas

    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...

  • Clinical Project Specialist

    hace 4 días

    Colombia, Huila Syneos Health Clinical A tiempo completo

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

  • Site Activation Partner Iii with Global Experience

    hace 3 semanas

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **Site Activation Partner (Sr CMA) with global experience -Home Based assigned to client - Chile/Colombia/Guatemala or Peru**: 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...

  • Clinical Project Specialist Ideal Opportunity for

    hace 1 día

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** 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 customers achieve their...

  • Clinical Project Specialist

    hace 1 día

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **Clinical Project Specialist - Fluent English - Home Based LATAM (Argentina, Brazil, Colombia, Mexico or Peru)** **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 you’ll have...

  • Site Contracts Specialist with Experience with

    hace 7 meses

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **Site Contracts Specialist 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...

  • Sr Cos- Bogota

    hace 1 día

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** - Description - External **Senior Clinical Operations 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...

  • Sr Project Specialist

    hace 6 días

    Colombia, Huila Syneos Health Clinical A tiempo completo

    **Description** **Senior 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...

  • Clinical Project Manager All Levels in Latam

    hace 2 semanas

    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...