See more Collapse

Clinical Evaluation Researcher

2 months ago

Ahmedabad, India Mantras2Success consultants Full time

Opening: 1 Nos.

Job ID: 63886

Employment Type: Full Time

Reference:
Work Experience: 2.0 Year(s) To 3.0 Year(s)

CTC Salary: 3.00 LPA TO 3.60 LPA

Function: Pharma / Biotech / Healthcare / Medical / R&D

Industry: Pharma/Biotech/Clinical Research

Qualification: B.Sc - General; B.Tech/B.E. - Bio-Chemistry/Bio-Technology

**Location**:

- Ahmedabad
**- Knowledge of Clinical Evaluation Reports (CER) as per EU MDR, MEDDEV 2.7/1 Rev 4.
- Perform the risk benefit analysis as per ISO 14971 to demonstrate the medical device benefits outweighed the residual risk.
- Writes and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, PMS and PMCF Plans/Reports, SSCPs, Regulatory Responses and other related documentation.
- Literature reviews, Appraisal of literature article for data suitability and data contribution, Writing literature summary.
- Knowledge of Clinical Evidence Summaries & Summarizing and analyzing data from clinical studies.
- Consulting, Editing statistical and clinical reports, review of medical journals and technical reports.
- Good knowledge on EU MDR, ISO 14155.
- Expertise in writing regulatory documents like Clinical evaluation reports(CER) pertaining to medical devices(end to end) as per MedDev 2.7.1 Rev 4.
- How to work on Gap analysis of CER's according to MEDDEV 2.7.1 Rev 4.
- Preparing literature search strategy,Screening and summarization by using PubMed,Google Scholar Writing Manuscripts(Research paper, Review articles,abstracts).
- Experience in Client Communication and Status Reporting.
- Assisting with other clinical, regulatory, quality and projects as assigned.
- Responsible for acquiring, interpreting, analyzing and drawing conclusions from clinical data from clinical trials, literature and experiences for a wide variety of medical devices specifically Ophthalmic Products.
- Strong knowledge and understanding of Good Clinical Practices and regulatory standards

**Qualification**:

- 2- 3 years in clinical, regulatory, quality work experience or 1-2 years in CER writing experience with solid knowledge of EU MDR Med Dev 2.7/1, rev 4.
- Bachelor Degree or Master’s Degree or PhD (preferred) in a scientific discipline.
- Able to read, analyze and implement regulations, standards and guidance
- Professional clinical research certification (e.g., Association of Clinical Research Professionals, Society of Clinical Research Associates)

**Key Skills**:

- Clinical Evaluation Reports
- Clinical Evidence

**Company Profile**:
One of the leading manufacturers of surgical appraratus especially in the Opthalmic field. One of the biggest IOL Manufacturer from INDIA.

We have other current jobs related to this field that you can find below

  • Clinical Research Coordinator

    2 months ago

    Ahmedabad, India Q Max Clinical Research Full time

    Support and coordinate day-to-day clinical trial activities - Work with research participants about the trial and participation rules - Oversee medication administration or device usage - Conduct data collection and record reported results, as well as volunteer information - Provide guidance on compliance with various guidelines and communicate any...

  • Clinical Research

    7 days ago

    Ahmedabad, India Orion Healthcare Solution Full time

    Hiring Clinical Research for our hospital based at Ahmedabad Requirement :2 Qualification : Diploma or degree in clinical research Anyone Interested can reach us at 7863825887/8758034095 **Benefits**: - Health insurance - Leave encashment - Provident Fund Schedule: - Day shift

  • Clinical Research Coordinator

    4 days ago

    Ahmedabad, Gujarat, India NovoBliss Research®️ Private Limited Full time

    Company DescriptionNovoBliss Research is a Contract Research Organization (CRO) located in Ahmedabad-Gandhinagar, India. Our spacious 10,000 sq. ft. facility is dedicated to advancing scientifically evidence-based products in cosmetics, OTC items, cosmeceuticals, and personal care. As a specialized CRO, we conduct trials in diverse industries, including...

  • Clinical Research Coordinator

    3 weeks ago

    ahmedabad, India NovoBliss Research®️ Private Limited Full time

    Company DescriptionNovoBliss Research® is a Contract Research Organization (CRO) located in Ahmedabad-Gandhinagar, India. Our spacious 10,000 sq. ft. facility is dedicated to advancing scientifically evidence-based products in cosmetics, OTC items, cosmeceuticals, and personal care. As a specialized CRO, we conduct trials in diverse industries, including...

  • Clinical Research Coordinator

    3 weeks ago

    Ahmedabad, India NovoBliss Research®️ Private Limited Full time

    Company Description NovoBliss Research® is a Contract Research Organization (CRO) located in Ahmedabad-Gandhinagar, India. Our spacious 10,000 sq. ft. facility is dedicated to advancing scientifically evidence-based products in cosmetics, OTC items, cosmeceuticals, and personal care. As a specialized CRO, we conduct trials in diverse industries,...

  • Clinical Research Coordinator

    3 weeks ago

    Ahmedabad, India NovoBliss Research®️ Private Limited Full time

    Company Description NovoBliss Research® is a Contract Research Organization (CRO) located in Ahmedabad-Gandhinagar, India. Our spacious 10,000 sq. ft. facility is dedicated to advancing scientifically evidence-based products in cosmetics, OTC items, cosmeceuticals, and personal care. As a specialized CRO, we conduct trials in diverse industries, including...

  • Clinical Research Coordinator

    3 weeks ago

    Ahmedabad, India NovoBliss Research®️ Private Limited Full time

    Company Description NovoBliss Research® is a Contract Research Organization (CRO) located in Ahmedabad-Gandhinagar, India. Our spacious 10,000 sq. ft. facility is dedicated to advancing scientifically evidence-based products in cosmetics, OTC items, cosmeceuticals, and personal care. As a specialized CRO, we conduct trials in diverse industries, including...

  • Clinical Research Coordinator

    3 weeks ago

    Ahmedabad, India NovoBliss Research®️ Private Limited Full time

    Company Description NovoBliss Research® is a Contract Research Organization (CRO) located in Ahmedabad-Gandhinagar, India. Our spacious 10,000 sq. ft. facility is dedicated to advancing scientifically evidence-based products in cosmetics, OTC items, cosmeceuticals, and personal care. As a specialized CRO, we conduct trials in diverse industries, including...

  • Clinical Research Coordinator

    3 weeks ago

    Ahmedabad, India NovoBliss Research®️ Private Limited Full time

    Company Description NovoBliss Research® is a Contract Research Organization (CRO) located in Ahmedabad-Gandhinagar, India. Our spacious 10,000 sq. ft. facility is dedicated to advancing scientifically evidence-based products in cosmetics, OTC items, cosmeceuticals, and personal care. As a specialized CRO, we conduct trials in diverse industries, including...

  • Clinical Research Coordinator

    2 weeks ago

    Ahmedabad, Gujarat, India Vertex Solutions Pvt Ltd Full time

    We are seeking a highly motivated and detail-oriented Clinical Research Coordinator to join our dynamic team. This entry-level position is ideal for recent graduates with a degree in B.Pharm or M.Pharm who are passionate about clinical research and looking to start their career in this exciting field. The Clinical Research Coordinator will play a crucial...

  • Clinical Research Associate

    1 month ago

    Ahmedabad, India Novo Nordisk AS Full time

    Department – Clinical Medical Regulatory (CMR) Do you want to be a part of a high performing team in Novo Nordisk that plays a critical role in driving the success of the business? Do you have what it takes: the right drive, a sharp mind, customer orientation, openness and focus on what matters and a genuine interest in working with people? If you...

  • Clinical Research Associate

    1 month ago

    ahmedabad, India Novo Nordisk AS Full time

    Department – Clinical Medical Regulatory (CMR) Do you want to be a part of a high performing team in Novo Nordisk that plays a critical role in driving the success of the business? Do you have what it takes: the right drive, a sharp mind, customer orientation, openness and focus on what matters and a genuine interest in working with people? If...

  • Clinical Research Associate

    1 month ago

    Ahmedabad, India Novo Nordisk Full time

    The position The Clinical Research Associate (CRA) is the primary point of contact between site staff and Novo Nordisk. In this role the CRA acts as ambassador for the company. As a CRA you will be responsible for: Taking leadership of site management for the selection (if applicable) and initiation of sites as well as conduction and closing activities...

  • Clinical Research Associate

    4 days ago

    Ahmedabad, Gujarat, India Novo Nordisk Full time

    The position The Clinical Research Associate (CRA) is the primary point of contact between site staff and Novo Nordisk. In this role the CRA acts as ambassador for the company.As a CRA you will be responsible for: Taking leadership of site management for the selection (if applicable) and initiation of sites as well as conduction and closing activities of...

  • Clinical Research Associate

    1 month ago

    ahmedabad, India Novo Nordisk Full time

    The position The Clinical Research Associate (CRA) is the primary point of contact between site staff and Novo Nordisk. In this role the CRA acts as ambassador for the company. As a CRA you will be responsible for: Taking leadership of site management for the selection (if applicable) and initiation of sites as well as conduction and closing...

  • Clinical Research Coordinator

    2 months ago

    Ahmedabad, Gujarat, India HCG Cancer Centre Full time

    Clinical Research Coordinator for clinical studies and trial of cancer patients **Job Types**: Full-time, Regular / Permanent **Salary**: ₹18,000.00 - ₹28,000.00 per month **Benefits**: - Health insurance - Leave encashment - Paid sick time - Provident Fund Schedule: - Day shift Supplemental pay types: - Yearly bonus **Education**: - Diploma...

  • Clinical Research Associate

    2 weeks ago

    Ahmedabad, India Cliantha Research Full time

    Job Description for Clinical Research Associate 1. Identify and qualify potential investigators to ensure that the sites have adequate time and can fulfill their obligation to the study. 2. To review research protocols and amendments, informed consent documents, case report form and/or other applicable business and project related documents to provide the...

  • Research Scientist Ii, Pre-clinical Toxicology

    6 days ago

    Ahmedabad, India BAXTER Full time

    **This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...

  • Clinical Research Associate

    1 month ago

    Ahmedabad, India Novo Nordisk Full time

    Department – Clinical Medical Regulatory (CMR) Do you want to be a part of a high performing team in Novo Nordisk that plays a critical role in driving the success of the business? Do you have what it takes: the right drive, a sharp mind, customer orientation, openness and focus on what matters and a genuine interest in working with people?  If you find...

  • Clinical Research Coordinator

    2 months ago

    Ahmedabad, India MediPharma Konnect Full time

    Overseeing the smooth running of clinical trials. - Collecting, coding, and analyzing data obtained from research. - Managing research budgets. - Informing participants about study objectives. - Administering questionnaires. - Monitoring research participants to ensure adherence to study rules. - Adhering to research regulatory standards. - Adhering to...