Global Post-Approval Studies, Manager at ZEISS Meditec Production in Dublin, California

Job Description:

GLOBAL POST-APPROVAL STUDIES, MANAGER

DUBLIN, CA

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.

Under the supervision of the Director, Global Post-Approval Studies, the Manager, Global Post-Approval Studies (GPAS) will assist the Sr. Manager(s), Global Post-Approval Studies in the operational execution of either Zeiss Sponsored phase IV (Post-Approval Studies), or physician-led studies (Investigator Initiated Trials). Other activities, special projects and assignments may be assigned as required. As a result, the percentage of time spent across key duties outlined below for which the employee is responsible for or assisting with will vary. This role involves appreciating the ingenuity in helping establish processes that will hold together the foundation for optimal scientific post-approval research, maintain team alignment to deliver the best to our customers and strengthen the current presence of ZEISS GPAS.

WE ARE LOOKING FOR PEOPLE WHO ARE KEEN TO TRY SOMETHING NEW:

* Study planning, protocol development, case report form development, region-specific documents, IRB submissions, investigator agreements, study contracts, informed consent development and logistics including contract agreements and study support materials. Assists in study close out activities.
* For Investigator Initiated Trials (IIT's): Assists Sr. Managers with IIT Portal submissions and processing and technical/operational issues
* Tracks study progress and reporting, investigator payments and study documents; ensures all applicable study start up documents are received and fully executed. Assists in study close out activities.
* Assists in the development of post-approval processes and procedures; modifying/creating document templates under supervision of Head of GPAS and team input
* Takes initiative to improve existing processes and facilitate team discussion for future improvement; routine tasks as assigned
* Maintains clinical knowledge of ZEISS Ophthalmology product lines; interaction with local ophthalmologists for firsthand experience of ZEISS products of interest, if needed by team

Additional Responsibilities:
* Handle and prioritize multiple tasks simultaneously,
* Work effectively in a team/matrix environment,
* Handle conflict management and resolution
* Understand clinical study budgets, quarterly budgets and development
* Full competency in Microsoft Office Programs
* Conduct their work activities in compliance with all relevant laws, regulations, and regulatory guidelines as well as Zeiss policies and procedures
* Keep alignment between processes for CZMI and CZM AG
* Work with professionalism and integrity in a fast-paced environment where we depend on the engagement of various stakeholders to be able to make valuable contributions to the field of ophthalmology

YOU ARE:

* Medical/scientific background and education highly desirable (OD or similar)
* 3+ years experience in OPT industries, such as cataract, refractive, glaucoma and retina spaces
* Experience as a clinical research associate desired
* Understand technical, scientific, and medical information related directly to ophthalmic surgical products and their usage. This includes refractive and diagnostic equipment
* Highly motivated and results-oriented with strong business understanding to align with overall organizational goals
* Ability to manage multiple projects at once
* Excellent written and verbal skills
* Embracing of core ZEISS mission and those of Medical Affairs & Professional Education 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.

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We are an EEO/AA/Veterans/Disabled employer.