Jobs
>
Bengaluru

    Executive / Assistant Manager - Clinical Operations (Clinical Research Associate) - Bengaluru, India - Viatris

    Viatris
    Viatris Bengaluru, India

    1 week ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Position Title : Executive / Assistant Manager - Clinical Operations (Clinical Research Associate)

    Location : Bangalore

    At VIATRISTM, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

    Viatris empowers people worldwide to live healthier at every stage of life.

    We do so via:

    • Access – Providing high quality trusted medicines regardless of geography or circumstance.
    • Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
    • Partnership – Leveraging our collective expertise to connect people to products and services.

    Every day, we rise to the challenge to make a difference and here's how this role will make an impact.

    Role Purpose

    The incumbent will work with Global Clinical Operations and Data Management teams to execute clinical research studies and provide data management deliverables at established and new Contract Research Organizations (CROs). This individual will ensure the proper monitoring, completeness, timeliness and quality of complex research studies and meet internal data reporting needs according to Good Clinical Practice (GCP), departmental Standard Operating Procedures (SOPs) and applicable regulations.

    Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal and state laws, health authority regulations/policies, and departmental processes.

    Key Responsibilities

    • Function as monitoring lead for assigned clinical Phase I-IV studies. Serve as liaison between the Mylan project team (Global Clinical Operations, Data Management, Clinical Science, Quality Assurance, etc.), Clinical Research Organizations (CROs), and clinical investigators regarding study activities to include the scope of the clinical study; data review, project time lines, and requests for documentation.
    • Perform comprehensive data management tasks and monitoring functions. Assist in the preparation of project plans and provide project reports to management as needed. Conducts data review, writing reports and resolving data clarifications.
    • Function as clinical data reviewer for multiple Phase I-IV focused CROs with responsibility to oversee assigned projects assigned to that CRO. Ensure the CRO is compliant with assigned study protocols, overall clinical objectives, GCP, SOPs and applicable federal, state and local requirements. Maintain all required regulatory study documents, monitoring records and correspondence confidentially and in accordance with Mylan document control procedures for assigned studies.
    • Review clinical and drug product documents for accuracy, completeness and timeliness internally and at the research sites. This includes review of completed source documents (including eDiary, DCFs, NTFs, etc.), Regulatory Documents, Drug Release/Accountability paperwork, Source Document templates, Case Report Form (CRF) templates, Informed Consent Forms, Adverse Events, Dosing Logs, Protocol Deviations, completed CRFs and Clinical Reports.
    • Conduct clinical monitoring of studies remotely and on-site as required according to Mylan SOPs and Clinical Monitoring Plan (CMP). This includes visit preparation, monitoring process, completion of the monitoring report, visit follow-up activities and travel to and from the clinical locations.
    • Interview clinical site research personnel in follow-up of monitoring visits and data issues. Communicate any substantial findings to his/her supervisor and clinical investigator during or immediately following a monitoring visit. Monitor and/or follow-up on the implementation of corrective action plans following clinical site inspections or audits, as required.
    • Develop and review SOPs where required. Responsible for identifying improved operational methods for functional area.
    • Oversee and assist in training of new Clinical Data Reviewer where required.
    • Perform other duties as assigned.

    Qualifications & Experience

    KNOWLEDGE

    Must possess knowledge of project management and data management skills and monitoring of clinical studies. Knowledge of and understanding of Good Clinical Practice and other associated regulations, guidelines and industry standards for clinical trials is required. Knowledge of medical terminology is desired.

    SKILLS AND ABILITIES

    Must possess excellent oral and written communication skills. Good organizational skills, attention to detail, ability to work as part of a team and the ability to manage multiple tasks is required. Must possess planning skills for a range of 6 months to 2 years in advance of study deadlines. Should be proficient in PC applications (Excel, Microsoft Word, etc.). Should have the ability to read and interpret documents. Ability to write routine reports and correspondence. The successful candidate must maintain a high level of professionalism and personal integrity

    SUPERVISION

    Position functions primarily autonomously and acts as a mentor to other Clinical Data Reviewers.

    EDUCATION/EXPERIENCE

    Minimum of a Bachelor's degree (or equivalent) and 2-4 years of experience in the field as monitor. Prefer 4-6 years of experience in the field. However, a combination of experience and/or education will be taken into consideration.

    LICENSES/CERTIFICATIONS

    Certification (i.e., ACRP) as Clinical Research Associate preferred, but not required.

    LANGUAGE SKILLS

    Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with groups of people such as other departments and communicate known concepts. Ability to present to a group or department.

  • Lilly

    Intern - Clinical Operations Analytics

    3 days ago

    Lilly Bengaluru, India

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, imp ...

  • Oivi

    Clinical Operations Lead

    3 days ago

    Oivi Bengaluru, India

    Do you want to help preventblindness on a global massivescale · Oivi is a fastpaced medtechstartup with offices in Oslo Norway and Bangalore India. We havestrong investors an experienced research & development teamand a product in commercial pilots. · Now thecompany is scaling it ...

  • Novotech Asia

    Clinical Data Programmer Sas

    2 days ago

    Novotech Asia Bengaluru, India

    **Brief Position Description**: · The Clinical Data Programmer SAS is responsible for data analysis and business intelligence activities related to study related clinical and operational data for the purpose of facilitating clinical data inspection and quality control, as well as ...

  • Novotech Asia

    Clinical Systems Liaison

    4 days ago

    Novotech Asia Bengaluru, India

    **Brief Position Description**: · The Clinical Systems Liaison is responsible for Collation, tracking and data entry of clinical trials systems data to support our growing clinical teams throughout the Asia Pacific region. To provide support across operations and systems and liai ...

  • GSK

    Centralized Monitoring

    1 day ago

    GSK Bengaluru, Karnataka, India

    **Site Name**: Bengaluru Luxor North Tower · **Posted Date**: May · Would you like to be part of GSK's emerging clinical leadership, with an opportunity to accelerate quality efforts across clinical operations on national and global scale? If so, this could be an excellent oppor ...

  • Apotex Research Private Limited

    Clinicalinvestigator,clinop-arpl-bc Ar

    3 days ago

    Apotex Research Private Limited Bengaluru, India

    **About Apotex Inc.** · **Job Summary**: · Handle and administer the BE studies or clinical trial in Bioequivalence center, India also managing the screening and in study assessment and medical care of clinical volunteers. · **Responsibilities**: · - Conducts duties following est ...

  • Novo Nordisk

    Associate Safety Operations Adviser

    6 days ago

    Novo Nordisk Bengaluru, India

    **Associate Safety Operations Advisor.** · **Department - GS GBS SOA, EA & SS and QPPV support.** · **Location - Bengaluru, India.** · **About the Department** · Global Safety, Bangalore has global responsibility for surveillance of Safety and Quality of Novo Nordisk clinical dev ...

  • Novotech Asia

    Clinical Data Programmer Iii Sas

    7 hours ago

    Novotech Asia Bengaluru, India

    **About the role**: · The Clinical Data Programmer SAS III (must be SAS Certified) is responsible for data analysis and business intelligence activities related to study related clinical and operational data for the purpose of facilitating clinical data inspection and quality con ...

  • Chaitanya HR Consultancy

    Female Branch Manger

    2 days ago

    Chaitanya HR Consultancy Bengaluru, India

    ***: · - Liaising with healthcare professionals and patients about treatment plans. · - Overseeing clinic operations and staff duties. · - Keeping medical professionals informed about healthcare administered at the clinic. · - Managing the clinic's budget, billing system, and inv ...

  • Novasyte

    Centralized Monitoring Dir

    1 week ago

    Novasyte Bengaluru, India

    Job Family Description: · A technical leadership role that drives adoptions and customization of operational tech tools and support to move to a more digital way of working aligned with the DCOM strategy. Able to lead/oversight to the overall clinical tech set-up and more readily ...

  • Labcorp

    Centralized Trip Report Reviewer-i

    1 day ago

    Labcorp Bengaluru, India

    Management of projects under direction of a Project Manager / Director as assigned. · - Ensure site monitoring responsibility for clinical studies are conducted according to Standard Operating Procedures, ICH Guidelines and GCP. Work Closely with project teams in implementation o ...

  • IQVIA

    Centralized Monitoring Dir

    1 week ago

    IQVIA Bengaluru, India

    Job Family Description: · A technical leadership role that drives adoptions and customization of operational tech tools and support to move to a more digital way of working aligned with the DCOM strategy. Able to lead/oversight to the overall clinical tech set-up and more readily ...

  • Novo Nordisk

    Associate Safety Operations Advisor

    1 day ago

    Novo Nordisk Bengaluru, Karnataka, India

    Associate Safety Operations Advisor · **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department**: Global Safety.- · **About the Department** · - Global Safety, Bangalore has global responsibility for surveillance of Safety and Quality o ...

  • Novo Nordisk

    Associate Safety Operations Adviser

    6 days ago

    Novo Nordisk Bengaluru, Karnataka, India

    Associate Safety Operations Adviser · **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department**: Global Safety.- · **About the Department** · - Global Safety, Bangalore has global responsibility for surveillance of Safety and Quality o ...

  • AstraZeneca

    Spirometry and Cardiac Safety Functional Process

    4 days ago

    AstraZeneca Bengaluru, India

    Global Clinical Solutions (GCS) drives the delivery of Technology and associated processes for the BioPharmaceuticals R&D organisation, owning and providing industry leading technology and services on behalf of Clinical Operations and its internal and external Partnerships. · The ...

  • Cytecare Hospital

    Registrar - Surgery

    1 week ago

    Cytecare Hospital Bengaluru, India

    **Roles and Responsibilities**: · - Adheres to the departmental policies and procedures, objectives, quality assurance programs, safety, environmental and infection control standards. Handles both outpatient and inpatient treatment. · - History taking and examination of patient i ...

  • Novo Nordisk

    Associate Safety Operations Advisor

    7 hours ago

    Novo Nordisk Bengaluru, Karnataka, India

    Associate safety operations advisor · **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department**: Global Safety.- · **About the Department** · - Global Safety, Bangalore has global responsibility for surveillance of Safety and Quality o ...

  • Novasyte

    42199 - Assoc Centralized Monitor

    7 hours ago

    Novasyte Bengaluru, India

    Job Overview · Provide project related assistance to assigned project teams. Ensure all work is conducted in accordance with standard operating procedures, policies, good clinical practices and applicable regulatory requirements. Meeting quality and timeline metrics. · Essential ...

  • Rich Slimming & Cosmetic Clinic

    Counselor

    6 days ago

    Rich Slimming & Cosmetic Clinic Bengaluru, India

    Looking for a passionate **Skin & Hair Cosmetic Clinic Counselor **who is willing to make a significant impact, drive sales and revenue for the clinic · **Roles and Responsibilities** · - _To ensure that the clinic meets/exceed the Sales Targets provided to it._ · - _To be respon ...

  • Novotech Asia

    Clinical Data Associate Ii

    1 week ago

    Novotech Asia Bengaluru, India

    **Organization Description** · Novotech is a leading Asia-Pacific biotech specialist CRO and consists of two operating brands, Novotech and PPC. Novotech is a clinical CRO with labs, phase I facilities, and drug development consulting services. · It has accumulated experience in ...