Johnson & Johnson Careers

[PROJECT GIFTS]Local Trial Manager

Beijing, China; Beijing, China
Clinical Trial Coordination


Job Description

Requisition ID: 1805674282W

• Perform country and site feasibility and prepare country feasibility report. Define any local criteria for site
selection. Ensure consistent conduct of pre-trial assessment visits and instruct appropriate follow-up of pre-trial
visit report information. Recommend suitable sites for selection.
• Lead and coordinate all local trial team activities in compliance with Company Standard Operating Procedures
and applicable regulations. Conduct local trial team meetings. Lead local project planning activities to meet
recruitment targets and to deliver high quality data on time and within budget. Including but not limited to:
development of trial specific procedures and tools, recruitment planning, risk management, budget forecasts,
resource forecasts. Maintain trial management systems up to date (e.g. CTMS, eTMF). Monitor trial progress
and initiate corrective and preventative actions when the trial deviates from plan.
• May be assigned to oversee outsourced studies.
• Organize and ensure local HA approval and any import/export permits.
• Review and approve regulatory document packages prior to site initiation in accordance with standard
operating procedures.
• Prepare country specific informed consent form templates. Review and approve site specific informed consent
forms in accordance with standard operating procedures.
• May lead negotiation of trial site contracts and budgets. Obtain and maintain relevant insurance.
• Forecast and manage local trial budget to ensure accurate finance reporting and trial delivered on budget.
Meet all finance reporting deliverables and timelines.
• May schedule and conduct a local investigator meeting.
• May be assigned trial sites to manage. Perform site management duties described in the Site Manager job
description.
• May identify and assess local vendors, support managers to develop and negotiate vendor contracts. Oversee
provision of agreed deliverables by selected vendors in accordance with the contract, protocol and applicable
SOPs.
• Review and approve trial visit reports and oversee the prompt and appropriate communication and follow-up of
findings and issues. Support the site manager with the follow-up of issues pertaining to safety, product
complaints and clinical supply management. Ensure that trial management systems are appropriately
maintained e.g. CTMS, eTMF.
• Comply with relevant training requirements. Act as local expert in assigned protocols. Develops strong
therapeutic knowledge to support roles and responsibilities. May represent Global Clinical Operations on cross
functional teams.
• Act as primary local country contact for a trial. Establish and maintain excellent working relationships with
external stakeholders, in particular investigators, trial coordinators and other site staff; and internal
stakeholders, including Medical Affairs and Marketing for Medical Affairs Trials.
• May be required to source drug supplies from the Clinical Supplies Unit or from commercial supplies, as
appropriate.
• Lead assigned process improvement initiatives.
• Train and mentor company staff as required.
Qualifications
• Tertiary qualification; life science, medical, paramedical, pharmaceutical related degree
• At least 3‐4 yrs pharma company or CRO clinical research experiences;
• Solid site management experience, preference will be given to those with project management experiences
• Demonstrated strong understanding of company's systems and processes
• Demonstrated proficiency in the monitoring and management of clinical trials (preferably with LTM experience)
• Preferably Hands‐on experiences of related Therapeutic areas
• At least 2‐3 years in SM position in the industry
• Both R&D and MAF trial experiences is preferred
• Proven track records of good performance
• Team orientated personality with high degree of flexibility
• Strong English skills, both oral and written
Primary Location
China-Beijing-Beijing
Other Locations
Asia Pacific-China-Beijing-Beijing
Organization
J&J (China) Investments Ltd (7046)
Job Function
Clinical Trial Coordination
Requisition ID
1805674282W