Local Study Manager

阿斯利康; Hong Kong; On-site; HKD 900,000 - 1,300,000; Full time

Benefits offered by this job

Generous allowances

Regular medical checkups

Medical and dependents insurance

Social security benefits

Flexible benefits

Free lunch

Company pension

Bonuses

Meal subsidies

Training

Transport stipend

Job summary

AstraZeneca in Hong Kong seeks an experienced SDTL/LST Lead to plan and deliver all components of a clinical study on time, within budget and to high quality, from Study Specifications through CSR. The role includes leading Local Study Teams at country level, coordinating resources, budgets and timelines, and ensuring AZ procedures, ICH-GCP and local regulations are followed.

LSTLs may also perform site monitoring as needed within a flexible capacity model.

Qualifications

• Bachelor degree in life sciences or healthcare
• 6+ years in Clinical Operations or related fields
• Experience leading Local Study Teams (LSTs)
• Excellent English communication and IT system skills

Responsibilities

• Lead the delivery of all components of a clinical study from SS to CSR on time, within budget and to quality.
• Lead Local Study Team(s) at country level, ensuring resources, budgets and timelines comply with AZ procedures and ICH-GCP.
• Perform site monitoring as needed within a flexible capacity model and archive all study documentation.

Skills

Clinical operations

LST leadership

Project planning

ICH-GCP knowledge

English proficiency

Education

Bachelor's degree in life sciences or healthcare

Job description

1. Serve as SDTL , plan and Lead the Delivery of all components of a clinical study to time, cost, and quality from Study Specifications (SS) through study closeout activities and Clinical Study Report (CSR).

2. To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.

3. In addition to leading LST(s), LSTL is expected to perform site monitoring if needed. As part of theflexible capacitymodel it is expected that LSTL manages both roles.

LSTL is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.

Job Descriptions

1. Serve as SDTL , plan and Lead the Delivery of all components of a clinical study to time, cost, and quality from Study Specifications (SS) through study closeout activities and Clinical Study Report (CSR).

2. To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with AZ Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.

3. In addition to leading LST(s), LSTL is expected to perform site monitoring if needed. As part of theflexible capacitymodel it is expected that LSTL manages both roles.

LSTL is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.

Job Qualifications

• University degree and/or equivalent, biological science or healthcare-related field.
• Clinical background. With global study experience.
• Minimum 5 years experience in Clinical Operations or other related fields. Working as LSTL for at least 1 year.
• Excellent knowledge of spoken and written English. Good ability to learn and to adapt to work with IT systems.

【AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

阿斯利康是一家提供平等机会的企业，我们将考虑所有符合条件的求职者就业。不因残疾、性别或性取向、怀孕或产假状况、种族或民族或族裔出身、年龄、宗教或信仰、性别认同或变更、婚姻或伴侣关系、受保护的退伍军人身份（如果适用）及任何其他受法律保护的特征而产生歧视。】

Job Type

Recruitment Type：Experienced

Work Type：Full-Time

Job requirements

• Degree：Bachelor at least
• Work Experience：6Y+

Benefits

• 丰富补贴
• 定期体检
• 医疗保险及子女医疗保险
• 五险一金
• 弹性福利
• 免费午餐
• 企业年金
• 奖金
• 五险一金商业保险等福利
• 津贴
• 培训
• 通讯补贴