Study Start-up Manager for Biopharma Department

6 months ago

กรงเทพมหานคร, Thailand AstraZeneca Full time

**Study Start-Up Manager**
**Job Summary**:
The Study Start-Up Manager (SSU Manager) is responsible at country level for managing and conducting start-up activities in compliance with the company procedures, documents, local and international guidelines such as ICH - GCP and relevant regulations.
The SSU Manager will prepare, review, track and manage site regulatory documentation at country and site level, and will maintain, review and report on site performance metrics.
The SSU manager works in close collaboration with the CRAs and the Local Study Team/Local Study Associate Director to ensure that study start-up activities and milestones are achieved in a timely and efficient manner.

**Typical Accountabilities**:

- Contribute to ensure that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
- Actively participates in Local Study Team (LST) meetings.
- Update CTMS and other systems with data from study sites as per required timelines during the start-up period.
- Follow up on outstanding actions with study sites during start-up period to ensure resolution in a timely manner.
- Ensure timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, AZ SOPs and local requirements. Support QC checks performed by LSAD or delegate to ensure that all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with AZ SOPs.
- Provide regular information to Line Managers at country level on study and planned study milestones/key issues during the start-up period.
- Provide feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
- Support SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management.

Upon local decision, additional responsibilities may include*:

- Prepare, review and negotiate contracts with investigational sites being the primary point of contact for investigational sites to ensure the contracts are fully executed
- Support site selection process by identifying and assessing potential sites/investigators
- Assist in initial forecasting for budget, study materials and drug supplies. Plan applicable local drug activities (local purchase or reimbursement)

**Minimum Requirements and Preferred Background**:

- Minimum University degree, preferred in Pharmacy or healthcare-related field.
- Minimum 5 years’ experience in Clinical Operations
- Excellent knowledge of spoken and written Thai and English.
- Good ability to learn and to adapt to work with IT systems.
- Good project management, decision-making, coaching, interpersonal, negotiation skills.
- Excellent communication skills, verbal and written and presentation skills.

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