Clinical Trial Manager to Sr. Clinical Trial Manager

Department: Global Clinical Development - Clinical Operations

Location: onsite in Guangzhou, or remote in Beijing with at least 50% travels to Guangzhou site for meetings

Employment type: Full-time

 

Position Summary

The CTM or Sr. CTM will be responsible for the management of 1 or more clinical trials including management of both the cross-functional internal team as well as vendors to ensure Angitia’s clinical trials are executed efficiently, on time, within budget and in compliance with SOPs, applicable regulations, and ICH/GCP guidelines.

This position will report to the China Director of Clinical Operations.

Responsibilities

• Lead the cross-functional Study Management Team (SMT) to ensure objectives of the Clinical Development Plan (CDP) are met and that deliverables are completed on-time and within budget.
• Oversee the identification, selection, on-boarding, and management of study vendors including CROs, central /specialty labs, and imaging vendors, etc.
• Main point of contact for Full-service CRO including all sub-contracted activities.
• Provide study-specific training and direction/oversight to vendor personnel to ensure study delivery per the scope of work and key performance indicators.
• Oversee and partner with external and internal stakeholders to ensure clinical trial data, from a variety of sources is appropriately captured, monitored, source-verified, edit-checked, reconciled and otherwise ‘quality assured’.
• Contribute to clinical operations deliverables by providing updates (g. DSUR/Annual Report, IBs, protocols, ICFs, CRFs, and CSRs).
• Review and approve study management plans (g. vendor oversight, TMF oversight, risk management, quality management, and monitoring), and ensure team adheres to plans and conducts studies in accordance with ICH GCP and applicable regulations.
• Timely review of invoices and payments, monthly accruals and forecast budget variances.
• Review and approve monitoring reports per monitoring plan and escalate as needed.
• Track key study activities using tracking tools.
• Identify issues and risks and propose potential resolutions.
• May require up to 50% travel.c

Qualifications

Minimum Requirements – Education and Experience:

Clinical Trail Manager:

• Bachelor’s degree or above in life sciences, nursing, or a related healthcare field is required or preferred.
• At least 3-4 years of CRA experience plus 2-4 years of study management experience is required.

Sr. Clinical Trail Manager:

• A Bachelor’s degree or above in life sciences, nursing, or a related healthcare field is required or preferred.
• At least 3-4 years of CRA experience, plus 4-5 years of study management experience is required.

 

Other qualifications:

• Strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management, and monitoring.
• Strong experience in management of CROs and other vendors.
• Proven project management skills, leadership ability and critical thinking skills.
• Knowledge of NMPA Regulations, ICH Guidelines, and GCP governing the conduct of clinical studies.
• Experience leading global clinical research activities, both early and late development experience preferred.
• Exceptional project management, cross-functional team leadership and organizational skills.
• Excellent interpersonal, written and verbal communication skills.
• Excellent computer skills in the following programs: MS Word, PowerPoint, Excel and Project Management.
• Effective team player and ability to influence and collaborate with cross functional clinical study teams.
• Strong leadership skills, self-motivated, adaptable to a dynamic environment.
• Effective written and interpersonal communication skills, specifically in English
• Ability to make decisions, set priorities, and share resources to benefit the whole organization.
• Strong analytical skills with a data driven approach to planning, implementing, and problem solving.
• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization.

Note: the final job title will be commensurate with the candidate’s seniority, skills and level of experience.