岗位职责:

1. Provide consistent and effective site contract and budget strategy, oversight, and support to clinical trials by taking on the following responsibilities:

Offer up-front and ongoing strategic planning specific to the program and needs of individual studies as related to site contracts and budgets

Develop and continually enhance a robust budget development strategy, and ensure consistency across the portfolio

Oversee CROs (and or functionally outsourced vendors) for the development and approval of global investigative site budgets (via appropriate tools e.g. GrantPlan)

Develop directly or provide expert input to the development of site budgets as required for the studies

Monitor and audit Investigator payments made by CROs to ensure timeliness, accuracy, and compliance with terms of Clinical Trial Agreement and tax requirements

Monitor KPIs, including cycle times and SIV targets, to ensure adherence to established study timelines

Attend Study Team meetings on an “agenda-driven” basis, i.e. when strategic decisions that impact site contracts are being discussed

Manage issues and risks by acting as a single point of contact within GCO for site contracting challenges and evaluating investigative site budget escalations and FMV deviations

Collaborate with relevant stakeholders (e.g. Regional Site Engagement Management RSEMs) to establish country level contracts strategy, monitor trends, and refine existing guidance, tools, and templates

Serving as a point of contact to address site contract related tax-related matters in collaboration with relevant DS stakeholders (e.g. corporate tax team)

Collaborate with the appropriate stakeholders within and outside of GCOP, including but not limited to GCOP Leadership, GCOP Study Management, CROs, Procurement, Legal, Corporate Compliance, Clinical Development, Global Project Management, and Functional Quality groups, to ensure study specific processes and expectations are mutually well understood


2. Process Documentation and Improvement:

Support build of Standard Operating Procedures and Work Instructions and ensure they are current and documented per Quality Documentation requirements and DSI process management standards

Ensure appropriate performance and quality targets are established (via metrics and KPIs) and oversight is maintained to understand target realization

Lead and/or support identification and implementation of improvements to the site contract and budget processes. Support activities include but are not limited to conduct of gap & impact assessment and developing project scope and project plans

Work cross-functionally with stakeholders to identify when a process revision is required

岗位要求:

1. 4 years'site contract and budget management relevant experience is required in the multinational pharmaceutical industry.

2. Demonstrated success in working cross-functionally in a global matrix organization; minimum 2 years’ experience in managing or supporting global cross-functional processes.

3. Have previous experience with Site Contracts and budget management.

4. Have experience in Clinical Operations and have a thorough understanding of GCP, relevant ICH standards. Preference is given to understanding the site contract operations and relevant working experience in other APAC regions.

5. Excellent negotiation skills, conflict resolution, decision making skills, communication (oral and written) and presentation skills in both Chinese and English.

6. Strong organizational skills, including the ability to prioritize needs and handle a high volume of tasks within a given timeframe.

7. Proven networking skills and ability to share knowledge and experience amongst colleagues.

8. Good interpersonal skills and ability to work in an international team environment.

9. Integrity and high ethical standards.