Clinical Project Manager 384 views0 applications

Job Description

Job Purpose

      Responsible for operational aspects of assigned clinical trial(s) executed by GBS Clinical Trial Services on behalf of Novartis Organizations and under the lead of Trial Lead
      Work with the Clinical Trial Lead, Trial Coordinator and Team to ensure successful trial execution from protocol generation to clinical trial report/manuscript writing.
      Responsible for ongoing and effective collaboration with Sponsor, GBS Line Functions ( medical writ-ing, statistics, data management, monitoring, etc.) and third-party vendors.

Major Activities

      1. Member of the Clinical Trial Team, support the trial Lead to ensure trial deliverables are met according to timelines, budget, quality standards and operational procedures.
      2. Work with the Trial Lead on investigators meeting organization and all internal meetings re-lated to the clinical trial execution and operational excellence
      3. In collaboration with the GBS or Sponsor Medical representative, contribute to the trial data ongoing medical/scientific quality review,
      4. Project / trial allocation plans within given indications and implementation to ensure optimum patient accessibility, resource utilization / allocation and country. Work closely with the Regional Monitoring Managers on trial feasibility and subsequent patient enrolment. Develop contingency plans as appropriate.
      5. Ensure and sign off high quality Monitoring Plans and other study plans and reports.
      6. Work with GBS Line Functions and partners to identify potential operational issues and implement actions to resolve them. Work with GBS Clinical Data Sciences team to ensure timely availability of reports / activities needed to track trial performance. Escalate issues endangering data quality and deliverables to the next level if no solution can be achieved
      7. Work with Trial Lead and trial Coordinator for the development, management and tracking of trial budget (internal and external costs) working closely with the GBS Finance and Spon-sor representative. Accountable for accuracy of trial information in all trial databases and tracking systems. Support the Trial Lead in the preparation and presentation of the trial budget to Sponsor representatives.
      Ensure cost reconciliation after trial completion in appropriate payment systems,
      8. Work with Drug Supply Management to ensure appropriate planning and of trial medication as well as keep overview of drug availability.
      9. In collaboration with trial Lead, may contribute to the development of protocol as well as clinical sections of regulatory documents like Investigators Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions, review of clinical trial application packages (as needed).

 

Salary:INR As per company norms

Industry:Pharma / Biotech / Clinical Research

Functional Area:Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology

Role Category:R&D

Role:Clinical Research Manager

Desired Candidate Profile

Education-

UG:Any Graduate – Any Specialization, Graduation Not Required

PG:Any Postgraduate – Any Specialization, Post Graduation Not Required

Doctorate:Any Doctorate – Any Specialization, Doctorate Not Required

    Please refer to the Job description above

 

Leave your thought

Share this job
We are a Staffing and Software Development company and a community of passionate, purpose-led individuals. We think disruptively to deliver technology to address our clients' toughest challenges, all while seeking to revolutionize the IT industry and create positive social change. A&J Global Solutions share the same cultural characteristics and imperatives. We come to work as ourselves. We enjoy each other’s company. We value honesty and transparency. Appearances and backgrounds aren’t important to us; ideas and doing the right thing are.We abhor and reject discrimination and inequality and promote diversity in all its forms. We proudly, passionately and actively strive to make both A&J Global Solutions and our industry more reflective and inclusive of the society that we serve.We are focused on helping our industry improve,& believe in sharing what we learn.We do this by writing books,talking at conferences,& championing open source.Our Agile development tools help our clients continuously improve & deliver quality software.
Connect with us

This is a demo store for testing purposes — no orders shall be fulfilled.