Job Title: Regulatory Start Up Manager
The primary objective of this role is to ensure the rights and well-being of trial participants are protected, and the reported trial data are accurate, complete, and verifiable from source documents.
This involves being the primary contact between investigational sites, sponsors, and other stakeholders. The key responsibility is to manage site relationships to ensure clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and standard operating procedures.
We offer flexible working arrangements and full flexibility in working hours to ensure staff achieve a work-life balance.
Minimum Qualifications & Experience:
* Graduate in a clinical or life sciences-related field.
* Relevant experience/qualifications in allied professions may also be considered.
Responsibilities:
1. Build relationships with principal investigators, study coordinators, pharmacists, and all relevant site trial personnel to ensure efficient management of clinical trials.
2. Foster internal and external customer relationships to ensure timely and productive project delivery as per study requirements and timelines.
3. Collaborate with in-house teams to prepare site essential documents and support ethics and regulatory submission and approval processes as needed.
4. Understand local and international regulatory requirements as relevant to specific clinical trials.
5. Ensure recruitment of participants as per site target.
6. Drive site recruitment and engagement initiatives and prepare site-specific recruitment plans.
7. Monitor investigational sites as per ICH GCP guidelines, including site selection, initiation, monitoring, and close-out visits.
Benefits:
* Hybrid working arrangements.
* Flexible working hours.
* Wellness programs.
* Ongoing development programs.
Others:
Novotech is committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect.
Our team members are passionate about what they do, but we understand work is only one of the things that is important to them.