(Sr.)Clinical Trial Operation Specialist at Abbott

Beijing, China

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, PharmaceuticalsIndustries

Requirements

Bachelor or above degree
Background in Clinical Laboratory immunology, clinical medicine or related specialty
Minimum 3 to 5 years Clinical trial experience, technical support or registration experience of IVD is preferred
Skills in English listening, speaking, and writing
Experience with statistical software is preferred
Expertise in communication, managing multiple priorities, and computer literacy
Knowledge and experience in international standards (ICH/GCP) and local regulations
Global study experience is preferred
Experience working or interning at an MNC is preferred
Receive clinical trial regulation and GCP training

Responsibilities

Support manager to coordinate new sites for clinical trials; evaluate new site capability and compliance
Manage the clinical trial site database; collect and analyze clinical trial procedures, IRB documents, IRB/EC frequency, contract information
Monitor online clinical trial activities
Coordinate and manage locked sites to ensure clinical trial operation follows unique protocol and standards
Draft clinical trial protocol to meet regulatory regulations and guidelines; adjust supplementary requirements from authorization agencies
Coach CT persons and actualize CT operations when necessary
Manage CT sample and adjustment
Make orders for clinical trial assays and coordinate with supply chain for on-time shipment
Handle original document and data management and archiving
Explain to evaluation experts if necessary
Deal with self-inspection, prepare for on-site inspections and related document preparation
Ensure all steps are on-time, including but not limited to IRB approval, contracts, filing, sample collection and testing, signatures and stamps
Ensure feasibility and quality of clinical trial protocol

Skills

Key technologies and capabilities for this role

Clinical TrialsGCPIRBProtocol DraftingSite ManagementRegulatory ComplianceSample ManagementData ManagementStatistical SoftwareEnglish CommunicationComputer Literacy

Questions & Answers

Common questions about this position

What is the location for this position?

The position is located in China > Beijing : Canway Building.

What is the base pay for this role?

The base pay for this position is listed as N/A, and in specific locations, the pay range may vary from the range posted.

What education and experience are required for this role?

A Bachelor’s degree or above is required, with a background in Clinical Laboratory immunology, clinical medicine or related specialty. Minimum 3 to 5 years of clinical trial experience, technical support or registration experience of IVD is preferred.

What key skills are needed for this Clinical Trial Operation Specialist position?

Skills required include English listening, speaking, and writing; experience with statistical software (preferred); expertise in communication, managing multiple priorities, and computer literacy; plus knowledge of international standards (ICH/GCP) and local regulations.

What makes a strong candidate for this role at Abbott?

Strong candidates have global study experience and prefer experience working or interning at a multinational company (MNC).

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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