Jobs
>
Chennai

    Senior Associate, Central Monitor, Risk Based Monitoring, CDS - Chennai, India - Pfizer

    Pfizer
    Pfizer Chennai, India

    Found in: Talent IN C2 - 4 days ago

    Default job background
    Full time
    Description
  • ROLE SUMMARY The Senior Associate, Central Monitor is responsible for ensuring the completeness, quality and integrity of the subject data in the clinical trial database under Risk Based Monitoring (RBM) mode. The areas of activity include but are not limited to: developing Risk-Based Monitoring system for applicable studies, ensuring key risk indicators (KRIs) properly defined and set up in the system to support the study, processing and reviewing study data in the system for the signal and action management, follow up for the issue resolution. The Senior Associate, Central Monitor ensures risk based monitoring activities comply with regulations, applicable Standard Operating Procedures (SOPs) and Processes at all times and is familiar with supported systems (RBM system, etc.) and able to troubleshoot and provide rapid response for all database issues. The Senior Associate, Central Monitor ensures quality oversight/control steps implemented in the central monitor activities. The Senior Associate, Central Monitor works with the global study team to meet the study objectives. ROLE RESPONSIBILITIES General:
  • Implement global strategies, initiatives, processes, and standards to ensure consistent, efficient, and quality processes to meet quality, timelines and deliverables.
  • Provide technical expertise to set up and test study level Risk-based Monitoring system
  • Review study level system outputs to process for the signal and action management
  • Plan and execute communication plans & methods to ensure customer satisfaction and enable improvements to be implemented during the course of a study.
  • Able to resolve conflicts, influence and communicate with key stakeholders and customers.
  • Implement quality oversight/control steps implemented in the central monitor activities.
  • System setup Functions:
  • Review protocols to ensure the set-up, review and reporting requirements can be met and are standardized.
  • Provide technical oversight, guidance and coordination for all the central monitor activities.
  • Set up and test RBM system at study level to ensure system quality.
  • Define key risk indicators (KRIs) in study system, and ensure consistency between the standard level and the study level.
  • Set up dictionary for data quality assessment DQA in study system
  • Ensure RBM system align with the protocol and adhere to ICH GCP, SOPs, corporate standards and regulatory requirements.
  • Data review Functions:
  • Work with Study Team to define the issue resolution for the reviewing findings as signal and action.
  • Develop, implement and maintain Quality Control related documentations for RBM related activities to ensure data completeness and accuracy.
  • Perform central monitoring activities including review system outputs, propose suggestion for signal and action management, and follow up with study team for the action resolution.
  • Work with Clinical Data Scientist to ensure all signal and actions are properly mitigated and RBM systems properly released.
  • Ensure lessons learnt during the course of the study are documented and shared with other central monitors/ study teams to facilitate cross-study learning.

    • BASIC QUALIFICATIONS:

  • Bachelor's degree or above of equivalent experience in a scientific or business related discipline required.
  • 3 - 5 years working experience in the clinical development fields.
  • Working knowledge of clinical development process, understanding concepts of Phase I-IV and principles of study design
  • Previous experience within a data management role, understanding key processes and principles associated with role including CRF design, database set-up, edit check specification, DMPs and data cleaning activities
  • Knowledge of clinical trial database and its applications
  • Knowledge of Windows Environment and its applications (Word, Excel, PowerPoint, Project, etc.)
  • Experience in Oracle, PL/SQL, SAS, Java, relational database design and database programming skills.

    • Technical Skill Requirements:

  • Technical expertise and business experience in supporting clinical trials database development, data management, site monitoring, etc.
  • Thorough understanding of the processes associated with clinical study management, data management, and regulatory operations.
  • Project management skills and technical capabilities as well as effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organization.
  • Works independently, receives instruction primarily on unusual situations
  • Ability to organize tasks, time and priorities; ability to multi-task
  • Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally
  • Strong understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption.

    • Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

    Medical#LI-PFE
  • CaratLane - A Tanishq Partnership

    Senior Devops Engineer

    Found in: Talent IN 2A C2 - 3 days ago

    CaratLane - A Tanishq Partnership Chennai, India

    CaratLane, India's first omnichannel jewellery brand was founded in 2008, by Mithun Sacheti, with a simple but courageous objective – to make beautiful jewellery accessible, affordable and forever wearable. With a strategic investment from Tiitan Company Limited and an eventual 1 ...

  • Mindsprint

    Senior Lead Performance Testing Engineer

    Found in: Talent IN 2A C2 - 4 days ago

    Mindsprint Chennai, India

    Job Description: · Develop comprehensive test strategies, plans, and execution for various products. · Conduct performance tests, including Spike, Endurance, and Load tests based on specified requirements. · Analyze test results, identify bottlenecks, and provide actionable solut ...

  • Eviden

    Service Virtualization

    Found in: Talent IN 2A C2 - 4 days ago

    Eviden Chennai, India

    Position: Service Virtualization · Job Description · 3+ years of hands-on experience in designing and developing virtual services and should be proficient with Broadcom DevTest or READYAPI SV or WireMock service virtualization tools. · Strong conceptual knowledge on service virtu ...

  • Mindsprint

    DevOps Architect

    Found in: Talent IN 2A C2 - 4 days ago

    Mindsprint Chennai, India

    Responsibilities: · Design and implement robust, scalable, and secure DevOps pipelines for continuous integration, delivery, and deployment. · Collaborate with development, operations, and security teams to define DevOps strategies and best practices. · Architect and automate inf ...

  • IDFC FIRST Bank

    DevOps Engineering Manager

    Found in: Talent IN 2A C2 - 8 hours ago

    IDFC FIRST Bank Chennai, India

    Job Purpose: · We are seeking an experienced and dynamic DevOps Engineering Manager with a strong background in AWS cloud services. The ideal candidate will be a hands-on leader, proficient in automated provisioning, cloud management, and possess expertise in Financial Operations ...

  • Swift Strategic Staff Solutions INC

    GCP DevOps Consultant

    Found in: Talent IN 2A C2 - 4 days ago

    Swift Strategic Staff Solutions INC Chennai, India

    Notice Period : Immediate / 30 Days · Skills : GCP, Devops, Dockers, CI/CD Pipelines, python, Java, Javascript, node JS, AWS. · Job Description : · - Past Equifax Account experience preferred. · - Provisioning cloud infrastructure (AWS, GCP) using infrastructure as code (Terrafor ...

  • TaskUs

    Senior Cloud Application Support and Security Specialist

    Found in: Talent IN 2A C2 - 3 days ago

    TaskUs Chennai, India

    What does a Senior Cloud Application Support and Security Specialist really do at TaskUs? At TaskUs, you will play a crucial role in ensuring the smooth functioning, security, and reliability of our organization's applications within the Agile Development Team. Think of yourself ...

  • LTIMindtree

    DevOps Architect

    Found in: Talent IN 2A C2 - 4 days ago

    LTIMindtree Chennai, India

    Hiring for Devops Architect (Multi Cloud) · Location: Chennai/Bangalore/Hyderabad/pune/Mumbai · Experience: 16 to 18 Years · Keywords for : GIT, Jenkins, DevSecOps, SAST, Terraform, Ansible, Docker, Kubernetes · DevSecOps Architect: · Requirements – · Mandatory: · • Overall 16 to ...

  • Cognizant

    Cloud Architect

    Found in: Talent IN 2A C2 - 5 days ago

    Cognizant Chennai, India

    Experience in provisioning, operating, and maintaining systems running on AWS environments leveraging services such as Elastic Beanstalk, ECS, EC2, Load Balancers, Auto-scaling, RDS, S3, CloudFormation, ElastiCache, CloudWatch, IAM etc. · Experience using Docker containers (Need ...

  • CGI

    Kubernetes Admin

    Found in: Talent IN 2A C2 - 4 days ago

    CGI Chennai, India

    Responsibilities: · • Responsible for setting up the support process for customer onboarding · • Manage all the Project customers platform incidents and issues · • Drive priority incidents by engaging business, development and infrastructure teams · • Promote and develop the cult ...

  • Horizon56

    DevOps Specialist

    Found in: Talent IN 2A C2 - 4 days ago

    Horizon56 Chennai, India

    Are you an expert in managing Azure infrastructure and application deployment in scale ? Are you service-minded, not afraid to take responsibility and can work independently? Then this position is for you. · Salary Range - Between 20 Lakhs to 40 Lakhs INR per annum depending on q ...

  • Swift Strategic Staff Solutions INC

    Azure APIM Engineer

    Found in: Talent IN 2A C2 - 4 days ago

    Swift Strategic Staff Solutions INC Bangalore/Chennai/Hyderabad, India permanent

    We are seeking a talented and experienced Azure Integration Specialist to join our team and play a key role in building, deploying, and managing robust API integration solutions using Azure technologies. · Key Skills: · Mandatory: · - Standard Logic Apps (not Consumption Logic Ap ...

  • Tech Mahindra

    APIGEE Support Engineer

    Found in: Appcast Linkedin IN C2 - 4 days ago

    Tech Mahindra Chennai, India

    We are looking for APIGEE Support Engineer with 8-10yrs of experience for Hyderabad and Chennai location who can join us immediately. · Experience installing, configuring, deploying, and maintaining API Management platforms like APIGEE · in developing APIs in APIGEE, troubleshoot ...

  • HTC Global Services

    Developer

    Found in: Talent IN 2A C2 - 2 days ago

    HTC Global Services Chennai, India

    Job Description · The Software Engineer – Operations Engineering is a critical member of the Technical Operations Team who works in a software development studio dedicated to reliability engineering. The studio is responsible for creating and improving projects that automate rout ...

  • Mirchandanis Career Placements India Pvt. Ltd.

    Lead Java Developer

    Found in: Talent IN 2A C2 - 1 day ago

    Mirchandanis Career Placements India Pvt. Ltd. Chennai, India

    The Software Engineering role specializes in planning, detailing technical requirements, designing, developing, and testing all software systems and applications for the firm. · Works closely with architects, product managers, project management, and end-users in the development ...

  • TransPerfect

    AWS Cloud Engineer

    Found in: Talent IN 2A C2 - 1 day ago

    TransPerfect Chennai, India

    JOB SUMMARY · • Working hours: India / UK shifts (10 AM to 7:30 PM IST / 1 PM to 10:30 PM IST) · • Location: Chennai, India · • Years of Experience: 7-10 years, of which minimum 5-6 years of hands-on experience with AWS. · RESPONSIBILITIES: · • Implementing cloud infrastructure t ...

  • L&T Technology Services

    DevOps Architect

    Found in: Talent IN 2A C2 - 1 day ago

    L&T Technology Services Chennai, India

    About us: · L&T Technology Services Limited (LTTS) is a global leader in Engineering and R&D (ER&D) services. With 816 patents filed for 57 of the Global Top 100 ER&D spenders, LTTS lives and breathes engineering and technology. Our innovations speak for themselves – World's 1st ...

  • REVEILLE TECHNOLOGIES PRIVATE LIMITED

    Senior Cloud Engineer

    Found in: Talent IN 2A C2 - 1 day ago

    REVEILLE TECHNOLOGIES PRIVATE LIMITED Chennai, India

    The Role : · The role of a Senior Cloud Engineer (AWS) requires a strong understanding of AWS services, infrastructure design principles, automation, security practices, and excellent problem-solving skills to deliver reliable and scalable cloud solutions. · Skills Requirements : ...

  • Blackstraw

    Senior DevOps

    Found in: Talent IN 2A C2 - 4 days ago

    Blackstraw Chennai, India

    Sr DevOps Engineer · Company Name: · Job Location: Chennai- Work from Office · Job Type: Full-time · Experience: 5 to 9 Years · Job Summary: We are looking for DevOps Engineers to help us build functional systems that improve customer experience. DevOps Engineer responsibili ...

  • Mastek

    Java kafka Developer

    Found in: Talent IN 2A C2 - 4 days ago

    Mastek Chennai, India

    We are seeking a talented and experienced Kafka, Spring, and Java Developer to join our team. As a Kafka, Spring, and Java developer, you will be responsible for developing, maintaining, and optimizing real-time data processing and streaming applications. You will work on buildin ...