Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Support

Job Category:

Professional

All Job Posting Locations:

Shanghai, China

1 Provide administrative and logistical support to Clinical Trial Assistant (CTAs), SM and/or

LTM in tracking progress of the trial, management of study data, budget, organizing

meetings, mailing and correspondence, materials, drug distribution and other relevant tasks

as appropriate in adherence to relevant SOPs, policies, and local regulatory requirements.

2 Support the local study team in performing site feasibility and/or country feasibility.

Collaborates with the Global Project Team, e.g. Clinical Trial Manager (CTM)/Global Trial

Lead (GTL), local management/Country Head and other study team members, as required.

3 Maintain information in relevant systems, including electronic filing (electronic Trial Master

File: eTMF).

4 Ensure current versions of the required trial documents, trial-related materials and supplies

are provided to the investigational site within required timeframes, as applicable.

5 Support CTA, SM and/or LTM in collecting/preparing documents required for study start-up/

submission to Ethics Committee/IRB and/or Health Authorities.

6 Support CTA SM and/or LTM in collecting, processing, and archiving study related

documents as appropriate. Use appropriate systems to ensure file completeness at

designated study milestones.

7 May assist team in conducting local investigator meeting or with planning for the investigators

participating in an international meeting.

8 Maintain and update contact information in relevant systems to ensure appropriate safety

updates distribution.

9 Comply with all training requirements, company policies & procedures and all applicable laws

and regulations. Always act aligned with J&J Credo.

10 Ensure inspection readiness at all times.

11 May contribute to process improvement.

12 Support SM and within a reasonable timeframe be able to take on responsibility in executing

activities within site initiation and start-up, preparation and conduct of site monitoring

(including remote monitoring), site management (by study specific systems and other

reports/dashboards) and site/ study close-out according to Standard Operating Procedures,

Work Instructions (WIs) and policies.

This is not an exhaustive, comprehensive listing of job functions. May perform other duties as

assigned.

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Behavior, Business English, Clinical Data Management, Clinical Trials, Clinical Trials Operations, Execution Focus, Issue Escalation, Laboratory Operations, Process Improvements, Process Oriented, Project Support, Regulatory Environment, Research and Development, Research Ethics, Study Management, Time Management