Header-Image

Asst Manager - Clinical Affairs

Bangalore

Step out of your comfort zone, excel and redefine the limits of what is possible. That’s just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people.

We are looking for people who are keen to try something new:

  • Overall responsibility for CA operations
  • Ensure continuous growth & Improvement of CA functions
  • Lead the planning process and quality management of clinical studies in CARIn
  • Manage clinical study sites (ICH/GCP compliance)Coordinate with statutory & regulatory authorities/internal interfaces and to comply with related issues
  • To manage day to day operations / functions of CA
  • To implement the guidelines / instructions for compliance with various regulatory authorities as applicable
  • Build and maintain excellent relationships with KOLs and ZEISS customers
  • Work as a part of CARIn team to achieve common goals
  • To ensure proper clinical development programs of Zeiss medical products
  • To ensure development of proficient knowledge on medical device regulations specifically on MDD/USFDA/EU (CE marking) /ISO
  • To support & work collaboratively with Product management / Quality / Regulatory / R&D departments
  • To ensure development of proficient knowledge on Zeiss ophthalmology products & applications on specific therapy areas in ophthalmology
  • To conceptualize & prepare clinical study outline / clinical study protocols
  • To Design & prepare case report forms / Informed consent forms
  • To Identify, network, negotiate & select clinical study sites
  • To ensure submission of study documents to EC in compliant with their SOPs
  • To establish & train clinical study site staff / team to perform specific studies
  • To periodically monitor & ensure clinical quality control of the data generated at clinical study site
  • To ensure management of DAEs in compliance with ICH-GCP/MDD
  • To ensure completion of all study activities / data collection and conduct study site closure in compliance with IEC/IRB guidelines
  • To prepare clinical study reports, support manuscript preparation & submission for publications

You are:

  • Preferable – Medical graduate (MBBS) with specialization in Ophthalmology or Optometrist
  • Minimum of 2-3 years experience in Clinical Research and managing clinical studies
In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together.

Join us today. Inspire people tomorrow.

Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.

Apply now! It takes less than 10 minutes.
QR-Code
Your contact
Girish Ravindran
girish.ravindran@zeiss.com
00
What we offer
Icon
Icon
Icon
Insights into our work
Share