IRT Senior Manager
An established research-based biotechnology company is advertising a vacancy for an IRT Senior Manager, based in their office in Shanghai. The organisation focuses on molecularly targeted and immuno-oncology cancer therapeutics, and prides itself on its pipeline that consists of small molecules and monocloncal antibodies. This is an exciting opportunity to work with a leading company that creates solutions with a meaningful and lasting impact on cancer patients.
- Interacting with regional business force to drive compliance ownership and accountability.
- Deciphering IRT study specific requirements to ensure proper risk mitigation while developing test plans.
- Authoring test scripts to ensure documented evidence is generated to prove that the system performs as intended.
- Leading UAT by defining, developing, and implementing practices and procedures for complete end user test plans.
- Providing training and support to team members to ensure successful execution of test scripts.
- Participating in the tracking and management of open issues and raises ongoing issues.
- Responsible for overall success of user acceptance testing, including verifying results and releasing approvals.
- Ensuring all user acceptance tests are documented according to standards.
- Understanding industry issues faced in sponsor driven IRT UAT efforts and supporting several moderately complex business processes.
- Gathering information about current work processes and information flows and documenting existing business process to define new enhancements to gain better efficiency in the testing process.
- Developing a strong knowledge of testing processes, methodologies, and tools.
- Communicating effectively via email and conference calls as needed.
- Providing guidance to cross functional teams and management on IRT best practices and trends.
- Ensuring systems and documentation are compliant with all Regulatory requirements, including cGMP, 21 CFR Part 11, and Annex 13, as well as in accordance with company SOPs and processes.
- Additional responsibilities as required.
Skills and Requirements:
- Demonstrable experience and education in a relevant or comparable capacity.
- multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Ada Li at +44 203 078 9576 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.