Clinical Trial Manager (Shanghai/Beijing)
Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong focus on Oncology and Rare Disease.
We are hiring for a Clinical Trial Manager (based in Shanghai/Beijing)
Position Summary:
Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work and ensures that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and all applicable regulatory requirements.
Essential functions of the job include but are not limited to:
Primary clinical point of contact with the client
Collaborate with PM on monthly invoicing and variance management of clinical budget
Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials)
Identify and develop training needs for CRAs and third-party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study Kick-off meetings
Generate potential site list from key stakeholders and drive site feasibility process
Identify potential risks to the enrollment targets based on feasibility analysis and site’s contracted commitment
Develop and finalize the country recruitment/retention strategy
Develop timely and effective communication and good working relationships with investigators and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out procedures
Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs
Address all CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriate
Support in planning and conducting investigator meetings
Review and/or approve of IP release packages
Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable
Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
Generate and utilize metric reporting (e.g. CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to PM and CRAs as appropriate
Responsible for eTMF implementation and management
Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) and is accountable for implementation and timely closure
Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits
Work closely with PM for project-specific resourcing issues
Escalate pertinent CRA performance and site compliance issues when necessary
Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines
Manage processes for investigational product (IP) including drug accountability and reconciliation
When a cross-functional PM is not assigned to a given program, the CTM will assume project management responsibility as needed
Supports business development and marketing activities as appropriate
May negotiate site budget and investigator contract with support from the legal department and/or site contracts group
May review site visit reports and ensures monitoring (i.e. scheduling and scope) is executed per monitoring plan
May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with PM
May perform clinical data review of patient profiles, data listings and summary tables, including query generation
May have line management responsibilities
May manages workload of supervised staff with continued assessment and adjustment as needed
Perform other duties as assigned by management
Qualifications:
Minimum Required :
Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred
Minimum of 5-8 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience. Oncology (Phase I) trial experience in Taiwan and China preferred
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.