Assoc. Clinical Supply Manager

1 week ago

Shanghai, China AbbVie Full time
Job Description

- Lead the establishment of clinical supplies processes and procedures in China, in partnership with support functions including Development, CDO, Global Trade Compliance (GTC), R&D QA, Regulatory & MA.

- Collaborate with Global CDSM team and other support functions to lead China Investigational Product (IP) Kick-Off meetings.

- Manage clinical site issues by working with cross-functional teams, including CDSM, CSM, and Regulatory.

- Assist in sourcing local products from China that meet global AbbVie Quality/Regulatory requirements, global clinical study expectations, and Chinese regulations for clinical trial use.

- Ensure adherence to local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards in conducting clinical trial supply. Stay updated on new and evolving local regulations, guidelines, and policies.

- Monitor regulatory reforms and industry trends in China and provide impact analysis of significant changes affecting clinical trial supply.

- Establish and maintain relationships with global and local cross-functional teams, clinical sites, and dispensing & destruction depots to ensure reliable delivery/destruction of the IP.


Qualifications

- Bachelor’s Degree in Life Science preferred (will consider Business Administration, Math, or Engineering with relevant work experience) with at least 4-6 years of experience in the Clinical Supply Chain Industry.

- High degree of flexibility and a strong aptitude for identifying innovative approaches in decision-making and problem-solving. Must proactively and effectively recognize, quantify, and mitigate potential risks.

- Proven leadership skills in managing complex projects.

- Ability to think in multiple dimensions and balance priorities to ensure timely and budget-friendly supply delivery of the highest quality, while adhering to regulatory requirements.

- Strong communication skills, fluent in spoken and written Chinese and English.

- Knowledge of GMP, GCP, GTC, etc. for clinical supply operations in China.

- Experience working with contract pharmaceutical organizations in China.



Additional Information

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

  • Assoc Project Mgr

    2 weeks ago

    Shanghai, Shanghai, China Thermo Fisher Scientific Full time

    Work ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve...

  • Assoc Project Mgr

    4 weeks ago

    Shanghai, Shanghai, China Thermo Fisher Scientific Full time

    Work ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionAt Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve...

  • Assoc Project Mgr

    2 weeks ago

    Shanghai, Shanghai, China Thermo Fisher Scientific Full time

    At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Manager, Clinical Research

    4 weeks ago

    Shanghai, Shanghai, China MSD Full time

    Job DescriptionMain ResponsibilityThe clinical research physician is expected to abstract high level relevant clinical and preclinical data and effectively use these data in supporting China registration. The clinical research physician is expected to address issues/questions raised.Whenever Clinical Research designs a clinical study, the clinical research...

  • Manager, Clinical Research

    2 weeks ago

    Shanghai, Shanghai, China MSD Full time

    Job DescriptionChina Development Center seeks individuals to provide leadership and experience in conducting clinical research in China. One of the most important mission of clinical research in China is to shorten gap of the drug lag in China so effective treatment options become available to Chinese patients. This individual will be the key driver of...

  • Manager, Clinical Research

    3 weeks ago

    Shanghai, Shanghai, China MSD Full time

    Job DescriptionChina Development Center seeks individuals to provide leadership and experience in conducting clinical research in China. One of the most important mission of clinical research in China is to shorten gap of the drug lag in China so effective treatment options become available to Chinese patients. This individual will be the key driver of...

  • Manager, Clinical Research

    4 weeks ago

    Shanghai, China MSD Full time

    Job DescriptionMain ResponsibilityThe clinical research physician is expected to abstract high level relevant clinical and preclinical data and effectively use these data in supporting China registration.  The clinical research physician is expected to address issues/questions raised.Whenever Clinical Research designs a clinical study, the clinical research...

  • Manager, Clinical Research

    3 weeks ago

    Shanghai, China MSD Full time

    Job DescriptionChina Development Center seeks individuals to provide leadership and experience in conducting clinical research in China. One of the most important mission of clinical research in China is to shorten gap of the drug lag in China so effective treatment options become available to Chinese patients. This individual will be the key driver of...

  • Clinical Trial Coordinator

    4 weeks ago

    Shanghai, China IQVIA Full time

    Responsibilities: • Trial and site administration: o Tracking (e.g. essential documents) and reporting (e.g. Safety Reports) o Ensure collation and distribution of study tools and documents o Update clinical trial databases (CTMS) and trackers o Clinical supply & non‐clinical supply management, in collaboration with other country roles o Manage Labeling...

  • Assoc Project Mgr

    4 weeks ago

    Shanghai, China Thermo Fisher Scientific Full time

    Work ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve...

  • Assoc Project Mgr

    4 weeks ago

    Shanghai, China Thermo Fisher Scientific Full time

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond...

  • Clinical Trial Coordinator

    2 weeks ago

    Shanghai, Shanghai, China IQVIA Full time

    Responsibilities:Trial and site administration:o Tracking (e.g. essential documents) and reporting (e.g. Safety Reports) o Ensure collation and distribution of study tools and documents o Update clinical trial databases (CTMS) and trackers o Clinical supply & non‐clinical supply management, in collaboration with other country roles o Manage Labeling...

  • Clinical Manager

    4 weeks ago

    Shanghai, China Abbott Full time

    1. Develop a thorough understanding of advanced heart failure and HM3 as a treatment option. 2. Become fully trained and certified to support HeartMate 3 cases, including assessing patient suitability and case planning. 3. Train and educate staff of clinical trial(s) and commercial indication inclusion criteria’s 4. Engage with relevant Chinese physician...

  • Clinical Manager

    4 weeks ago

    Shanghai, China Abbott Laboratories Full time

    Responsibilities:1.    Develop a thorough understanding of advanced heart failure and HM3 as a treatment option.2.    Become fully trained and certified to support HeartMate 3 cases, including assessing patient suitability and case planning.3.    Train and educate staff of clinical trial(s) and commercial indication inclusion...

  • Clinical Research Expert/Lead

    4 weeks ago

    Shanghai, China Roche Full time

    The Position Job Summary : 1. The person may actively participate on cross-functional project teams responsible for the clinical research activities to support Roche Diagnostic China registration of products developed by Roche Group globally, such as, clinical software, instrument platforms, assays, reagents, devices, instruments, systems and...

  • Associate Clinical Affairs Manager

    2 weeks ago

    Shanghai, Shanghai, China Philips Full time

    JOB DESCRIPTION Job Title Associate Clinical Affairs Manager Job Description In this role, you have the opportunity to · Provide Chinese clinical strategy for NPI; Lead the clinical plans development to be compliance with GCP, the regulation, Philips harmonized clinical SOPs; · Lead the clinical evaluation projects across the product lines, work...

  • Associate Clinical Affairs Manager

    1 week ago

    Shanghai, China Philips Full time

    Job TitleAssociate Clinical Affairs ManagerJob DescriptionIn this role, you have the opportunity to· Provide Chinese clinical strategy for NPI; Lead the clinical plans development to be compliance with GCP, the regulation, Philips harmonized clinical SOPs;· Lead the clinical evaluation projects across the product lines, work closely with Regulatory...

  • Associate Clinical Affairs Manager

    3 weeks ago

    Shanghai, China Philips Full time

    JOB DESCRIPTION Job Title Associate Clinical Affairs Manager Job Description In this role, you have the opportunity to · Provide Chinese clinical strategy for NPI; Lead the clinical plans development to be compliance with GCP, the regulation, Philips harmonized clinical SOPs; · Lead the clinical evaluation projects across the product lines,...

  • Associate Clinical Affairs Manager

    1 week ago

    Shanghai, Shanghai, China Philips Full time

    Job TitleAssociate Clinical Affairs ManagerJob DescriptionIn this role, you have the opportunity to· Provide Chinese clinical strategy for NPI; Lead the clinical plans development to be compliance with GCP, the regulation, Philips harmonized clinical SOPs;· Lead the clinical evaluation projects across the product lines, work closely with Regulatory team,...

  • Associate Director, Clinical Research

    4 weeks ago

    Shanghai, Shanghai, China MSD Full time

    Job DescriptionMain ResponsibilityThe clinical research physician is expected to abstract high level relevant clinical and preclinical data and effectively use these data in supporting China registration. The clinical research physician is expected to address issues/questions raised.Whenever Clinical Research designs a clinical study, the clinical research...