Clinical Study Administrator Team Lead

The Clinical Study Administrator Team Lead (CSA Team Lead) is responsible for ensuring CSAs’ assist in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team (LST) to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives.

The CSA Team Lead is responsible for the additional assigned roles as a senior CSA, such as study drug management role and vendor management role. For additional roles, JD addendum can be utilized.

The CSA Team Lead is responsible for line managing dedicated group(s) of staff and responsible for planning and utilization of staff resources, assigned budget, objective setting and performance follow-up.  

It is also expected that the CSA Team Lead may contribute to regional/global work tasks as delegated.

Typical Accountabilities

• Leadership of dedicated group, building the team spirit, developing team style and behaviour.
• Ensures adequate resources for the CSA tasks assigned.
• Ensures that the workload of direct reports is adequate.
• Development and performance management of direct reports.
• Ensures that direct reports have development and training plans, according to IDP process.
• Coaches the direct reports on a regular basis, and plans/organises coaching with external providers if needed.
• Prepares salary and bonus proposals for direct reports based on their performance in close collaboration with responsible CH/DSMM and local HRBP.
• Contributes to efficient SMM organisation and its functioning at country level by working closely with responsible CQAD/CH/DSMM.
• Contributes to successful delivery of SMM study delivery country level targets to plan, with speed and quality.
• Contributes to the quality improvement of the study processes and other procedures.
• Ensures completeness and timeliness of the eTMF to maintain it “Inspection Ready”.
• Provides direction to CSAs in resolving any key issues identified.
• Supports SMM region in initiatives/activities as agreed with CH/DSMM.
• Ensures that CSA’s activities at country level comply with local policies and code of ethics.

Upon defined departmental needs, leads the practical setting of new vendor including 3PRM and contracting process liaising with purchase team, in line with international and local codes.

Skills

• Excellent interpersonal skills.
• Manage change with a positive approach for self, team and business. Sees change as an opportunity to improve performance and add value to business.
• Excellent organisational, analytical, influencing and negotiation skills ensuring successful conduct of responsibilities.
• Excellent presentation and communication skills, verbal and written.
• Excellent knowledge of spoken and written English.
• Good ability to learn and to adapt to work with IT systems.
• Ability for national and international travel.

Qualifications

• Education: Bachelors degree
• Language: English, Korean
• Work Experience: minimum 5 years

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.