Novo Nordisk BSc Life Sciences RBQM Specialist Job Opening, Apply Online

Novo Nordisk BSc Life Sciences RBQM Specialist Job Opening, Apply Online

Advertisements

Location- Bangalore

Purpose of the job:

Advertisements

With the purpose of ensuring the right quality and efficiency, being the ambassador of Novo Nordisk RBQM processes and facilitating full adoption and execution across the trial portfolio and phases in all CDC countries via various interactions with different roles such as LoB manager, CDC Trial managers, CRA, CQTM and CDC management.

Key Accountabilities

Advertisements
  • Implementation & execution (50%)
  • Capability building / Training (30%)
  • Effectiveness check  (20%)

Main Accountabilities

  1. Implementation & execution (50%):
  • Identify gaps in RBQM implementation and/or execution in CDC and develop projects to address them.
  • Represent the CDC in regional and global RBQM networks and actively contribute to improving it.
  • Effectively communicate the expectations from the RBQM process within CDC.
  • Align the CDC RBQM activities/projects with Global ambitions.
  • Actively communicate the benefits of RBQM and set tangible targets for different teams together with the LoB managers and CDC Trial managers.
  1. Capability building/ Training (30%):
  • Provide input to related SOPs, training materials, tools and documents.
  • Identify the RBQM training gaps and drive CDC-level training along with regional and CDC CQTMs as required per role.
  • Develop a methodology to regularly check the new competencies (skills, ability & knowledge) required within the CDC to accelerate the implementation and execution of RBQM, and communicate those within regional & global networks.
  • Ensure the comfort of LoB managers in using RBQM tools, processes, documents and data to improve the right quality and efficiency.
  1. Effectiveness check (20%)
  • Develop CDC-level reports to measure implementation & execution rate, expected improved quality/ efficiencies with the help of RBQM.
  • Effectively and regularly communicate the trends and plans with all relevant stakeholders.

Challenges with regard to innovation and change

Advertisements
  • The position requires an understanding of ICH/GCP, local clinical trial regulatory requirements and Novo Nordisk SOPs.
  • The position holder needs to adapt to changes in the regulatory environment and internal Novo Nordisk procedures as well as help the team to adapt.
  • The position requires timely and active communication of issues, queries and progress.
  • The position requires knowledge of IT systems such as eTMF, and COSMOS used in the clinical area.
  • The position requires a good understanding of risk-based and innovative thinking.

Education requirements: Bachelor’s Degree or higher qualification in Pharmacy, Life Science or another related field.

Work experience

  • At least 3 years of clinical trial experience in Clinical Trials at a Sponsor or Clinical Research Organization.
  • Strong negotiation skills
  • Strong communication skills, verbal and written
  • Ability to be independent, multitask and result-oriented with a hands-on attitude in a fast-paced and energetic environment

APPLY ONLINE

Leave a Comment