Clinical Operations Manager

2 days ago

Bengaluru, Karnataka, India Parexel Full time ₹ 12,00,000 - ₹ 36,00,000 per year

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

The Clinical Operations Manager, TMF (Trial Master File) is responsible for participating in Parexel and department system/standards improvement activities, as well as back-end Operational Client support as required. The role will contribute to the understanding and anticipation of strategic, market and operational needs, and translating those needs into effective and improved processes and technical solutions.

Key Accountabilities:

Operational Excellence

  • Check quality of TMF team deliverables (e.g. TMF overview compliance with process and system steps, quality of queries) and propose appropriate remedial actions
  • Maintain a working knowledge of, and assure compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and Parexel SOPs
  • Participate in Parexel and department system/standards improvement activities
  • Liaise with functional senior management to provide and collect feedback on the process implementation  
  • Support the development of SOPs and tools with Process Owners as necessary  
  • Create and modify new/existing materials/job aides for TMF operations
  • Serve as internal Subject Matter Expert for Parexel project teams, providing guidance and support during project implementation 
  • Complete routine administrative tasks in a timely manner (e.g. timesheets, metrics, travel expense claims)

Business & Financial Management

  • Provide consultation, facilitate metrics collection and develop action plans in conjunction with Management/Project Leadership/Leads to keep projects on time and within budget
  • Support development of materials and plans for TMF business opportunities and maintain the relevant libraries

Personal Ownership

  • May be responsible for own assignments as SME. This includes taking the role of a senior level contributor on a project/account team and ensuring high quality and timely delivery of own deliverables.

Skills:

  • Demonstrated ability to successfully manage the tasks.
  • Excellent interpersonal, verbal and written communication skills (including experience in making presentations at conferences, meetings, training sessions).
  • Advanced client focused approach to work.
  • A flexible attitude with respect to work assignments and new learning.
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
  • Ability to work in a matrix environment and to value the importance of teamwork.
  • Excellent negotiation skills.
  • Advanced in networking
  • Excellent analytical and problem-solving skills.
  • Ability to provide guidance to other stakeholders as required.

Knowledge and Experience: 

  • Substantial trial master file coordination experience or equal experience in clinical

Education:

  • Educated to a degree level (biological science, pharmacy or other health related discipline preferred) or relevant clinical or business equivalent

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