The Quality Compliance Study Lead has the overall responsibility for onboarding new customers and ensuring QP Services activities are successfully delivered in clinical trials of new drug products. The Study Lead is the primary point of contact for stakeholders within Almac and clients.
Responsibilities
- Act as a principle contact for the customer requiring QP Services, keeping up to date with Clinical Trial legislation and providing expert advice in a consultancy capacity.
- Lead the QP Services activities at all stages, coordinating tasks and ensuring completion in line with the timelines agreed.
- Liaise internally within the QP and other internal departments globally to ensure the timely delivery of QP Services activities.
- Advise on QP related activities and responsibilities during the generation/revision of Technical Agreements.
- Escalate issues when appropriate.
- Record, collate and report customer specific KPIs, agreeing and implementing performance improvement plans where necessary.
- Follow through on all customer queries in a timely manner.
- Host /attend internal/external teleconferences/meetings, initiating QP related discussions for new or ongoing business, taking minutes, as required.
- Represent the QP Services Department during customer audits and sales visits, promoting Clinical Services expertise in Qualified Person related activities, in the generation of new or on-going business.
Criteria
- Bachelor’s Degree
- Experience with project management or facing clients in the pharmaceutical industry
- Excellent communication and stakeholder interaction skills
- Flexible
- Chinese or Japanese language skill are advantageous for interacting with Chinese or Japanese clients
Please note that the official title in the job offer may differ from advertised.
