Clinical Data Associate Ii

2 weeks ago

Bengaluru, India Novotech Asia Full time

**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 over 3,700 clinical projects, including Phase I to Phase IV clinical trials and bioequivalence studies. Novotech is positioned to serve biopharmaceutical clients conducting clinical trials in Asia and globally.
As of September 30, 2021, Novotech had over 2,000 FTEs across 11 geographies in Asia-Pacific, the United States and the UK.

**Employer Description**

Novotech has offices in 11 geographies across the region, and site partnerships with key medical institutions.
Novotech provides clinical development services across all clinical trial phases and therapeutic areas including feasibility assessments, ethics committee and regulatory submissions, data management, statistical analysis, medical monitoring, safety solutions, central lab services, report write-up to ICH requirements, project and vendor management. Novotech obtained the ISO 27001 certification which is the best-known standard in the ISO family providing requirements for an Information Security Management System. Together with the ISO 9001 Quality Management system, Novotech aims at the highest IT security and quality standards for patients and biotechnology companies.

**Brief Position Description**:
Supports the day-to-day operations of the data management projects, providing in-house data entry support to projects and administrative support to CDMs, according to GCDMP guidelines, local regulatory requirements and Novotech/Client SOPs.

Minimum Qualifications & Experience:
Graduate in a clinical or life sciences related field. Relevant experience/qualifications in allied professions may also be considered. At least one to two years' experience working in the research, pharmaceutical industry or a related field.

**Responsibilities**:
Member of the project team reporting to the Biometrics Project Manager on projects, the Clinical Data Associate II is responsible for providing accurate data acquisition, data validation and reconciliation to the clinical studies and shall ensure quality standards per SOPs and ICH-GCP.

1.Data entry of clinical trial data using Clinical Data Management software.

2.Assistance in review of data queries to be raised with sponsor companies/monitoring staff.

3.Tracking of CRF pages received and entered, tracking of data queries sent received and entered.

4.Assist CDM with database testing and edit checks testing as appropriate.

5.Assist CDM with data cleaning/validation and reconciliation of external data

6.Develop and maintain good communications and working relationships with lead CDMs.

7.Assist CDM to create reports, listings, and other output as required during the project.

8. May coordinate activities related to coding and electronic data transfers, and address resulting discrepancies.

9.Assist with the development and update of systems to track study progress as per the CDM requirements (i.e. Novotrak, CRF & query flow, safety reports, etc.). Provide updates on study progress to CDM as required.

10.Participation in project meetings as requested by CDM.

11.Assist with agenda/minute writing for data management teams.

12.Adherence to company Quality Policy and procedures as applicable to carrying out job responsibilities.

13.Provide general admin support to Data Management according to the needs of the Clinical Data Manager.

14.Active contribution to company process improvement initiatives as assigned.

15.Understand the responsibilities of Novotech as a service provider in the pharmaceutical industry and ensure all communications with external parties present a positive professional image of the company.

16.Participation in industry fora (conferences, professional associations, etc) as a means of professional development as well as promotion of Novotech' s image in industry.

17.Any other tasks associated with the day-to-day functioning of the DM Team as per the discretion and delegation of the Line Manager.

  • Clinical Data Associate Ii

    2 months ago

    Bengaluru, India Syneos Health Clinical Full time

    **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...

  • Clinical Data Manager

    2 weeks ago

    Bengaluru, India George Clinical Full time

    We are expanding! We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.Who are we?A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence20+ years of...

  • Clinical Data Manager

    1 week ago

    Bengaluru, India George Clinical Full time

    We are expanding! We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.Who are we?A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence20+ years of...

  • Clinical Data Manager

    1 month ago

    Bengaluru, India George Clinical Full time

    We are expanding! We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.Who are we?A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence20+ years of...

  • Clinical Data Manager

    2 weeks ago

    Bengaluru, India George Clinical Full time

    We are expanding! We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.Who are we?A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence20+ years of...

  • Clinical Data Manager

    2 weeks ago

    Bengaluru, India George Clinical Full time

    We are expanding! We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow. Who are we? A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence 20+ years of...

  • Clinical Data Manager

    1 month ago

    Bengaluru, India George Clinical Full time

    We are expanding! We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.Who are we?A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence20+ years of...

  • Clinical Data Associate Ii

    1 month ago

    Bengaluru, India Novotech Asia Full time

    Brief Position Description: Supports the day-to-day operations of the data management projects, providing in-house data entry support to projects and administrative support to CDMs, according to GCDMP guidelines, local regulatory requirements, and Novotech/Client SOPs. Minimum Qualifications & Experience: Graduate in a clinical or life sciences related...

  • Clinical Data Associate Ii

    20 hours ago

    Bengaluru, Karnataka, India Novotech Asia Full time

    Brief Position Description:Supports the day-to-day operations of the data management projects, providing in-house data entry support to projects and administrative support to CDMs, according to GCDMP guidelines, local regulatory requirements, and Novotech/Client SOPs.Minimum Qualifications & Experience:Graduate in a clinical or life sciences related field....

  • Clinical Research Associate

    4 weeks ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Title : Clinical Research Associate (CRA) Company : MS Clinical Research Pvt Ltd About Us : MS Clinical Research (MSCR) is a leading clinical research organization dedicated to advancing scientific discovery and improving healthcare outcomes. We are committed to conducting high-quality clinical trials and contributing to the development of innovative...

  • Clinical Data Manager

    21 hours ago

    Bengaluru, Karnataka, India George Clinical Full time

    We are expanding We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.Who are we?A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence20+ years of...

  • Clinical Data Manager

    24 hours ago

    Bengaluru, Karnataka, India George Clinical Full time

    We are expanding We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow. Who are we? A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence 20+ years of...

  • Clinical Data Manager

    16 hours ago

    Bengaluru, Karnataka, India George Clinical Full time

    We are expanding We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.Who are we?A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence20+ years of...

  • Clinical Data Programmer Ii

    2 months ago

    Bengaluru, India Novotech Asia Full time

    **Brief Position Description** The core responsibility for this position is as a member of the Data Management department at Novotech. The Clinical Data Programmer-II (CDP-II) will be responsible for programming activities on clinical trial projects and to ensure compliance with Good Clinical Data Management Practices (GCDMP). **Minimum Qualifications &...

  • Clinical Research Associate

    2 months ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Title: Clinical Research Associate (CRA)Company: MS Clinical Research Pvt LtdAbout Us:MS Clinical Research (MSCR) is a leading clinical research organization dedicated to advancing scientific discovery and improving healthcare outcomes. We are committed to conducting high-quality clinical trials and contributing to the development of innovative medical...

  • Clinical Research Associate

    2 months ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Title: Clinical Research Associate (CRA)Company: MS Clinical Research Pvt LtdAbout Us:MS Clinical Research (MSCR) is a leading clinical research organization dedicated to advancing scientific discovery and improving healthcare outcomes. We are committed to conducting high-quality clinical trials and contributing to the development of innovative medical...

  • Clinical Research Associate

    2 months ago

    Bengaluru, India MS CLINICAL RESEARCH Full time

    Job Title : Clinical Research Associate (CRA) Company : MS Clinical Research Pvt Ltd About Us : MS Clinical Research (MSCR) is a leading clinical research organization dedicated to advancing scientific discovery and improving healthcare outcomes. We are committed to conducting high-quality clinical trials and contributing to the development of innovative...

  • Clinical Data Associate Ii

    2 months ago

    Bengaluru, India Novotech Asia Full time

    **Brief Position Description**: Supports the day-to-day operations of the data management projects, providing in-house data entry support to projects and administrative support to CDMs, according to GCDMP guidelines, local regulatory requirements and Novotech/Client SOPs. **Minimum Qualifications & Experience**: Graduate in a clinical or life sciences...

  • 3 Days Left Clinical Data Manager

    21 hours ago

    Bengaluru, Karnataka, India George Clinical Full time

    We are expanding We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.Who are we? A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence 20+ years of...

  • Clinical Data Specialist

    23 hours ago

    Bengaluru, Karnataka, India George Clinical Full time

    We are expanding We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow. Who are we? A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence 20+ years of...