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 - Mandarin proficiency preferred, based in Australia.
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
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. Experience in Phase 1, FIH health-volunteer clinical trials.
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Mandarin language proficient required to support Mandarin-speaking clients.
Other Required:
- Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
- Excellent communication and interpersonal skills to effectively interface with others in a team setting
- Excellent organizational skills, attention to detail, and a customer service demeanor
- Ability to travel domestically and internationally including overnight stays
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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 myHR@precisionmedicinegrp.com.
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