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Precision for Medicine is a clinical research organization (CRO) that combines advanced technologies, scientific expertise, and operational scale to accelerate the development of life-changing therapies. The company specializes in oncology and rare disease clinical trials, integrating clinical trial execution with deep scientific knowledge, laboratory expertise, and advanced data sciences.
The Clinical Trial Manager will serve as the primary clinical lead responsible for planning, conducting, and overseeing the operational execution of clinical studies in accordance with protocol, SOPs, ICH-GCP guidelines, and all applicable regulatory requirements. This is a senior individual contributor role with significant responsibility for study success and client satisfaction.
Key responsibilities include:
- Serving as the primary clinical point of contact with clients
- Developing study-related clinical documents (clinical plans, ICF templates, study-specific forms, CRF guidelines, training materials)
- Identifying and developing training needs for Clinical Research Associates (CRAs) and third-party vendors; presenting at Investigator Meetings and Study Kick-off meetings
- Generating potential site lists and driving the site feasibility process
- Developing and finalizing country-specific recruitment and retention strategies
- Leading internal clinical team meetings and setting expectations for CRAs and Clinical Trial Assistants (CTAs)
- Addressing CRA and site questions; maintaining FAQ logs
- Overseeing submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments
- Developing clinical monitoring strategies to ensure study timelines and quality deliverables
- Generating and utilizing metric reporting (CTMS, DM Query Trends, monitoring reports) to track study progress
- Managing eTMF implementation and oversight
- Collaborating on Corrective and Preventative Action Plans (CAPA) development and implementation
- Supporting GCP audit preparation for sites and internal staff
- Escalating CRA performance and site compliance issues as needed
- Collaborating with data management on data quality and cleaning timelines
- Managing investigational product processes including drug accountability and reconciliation
- Assuming project management responsibility when a dedicated PM is not assigned
- Supporting business development and marketing activities
- Potentially negotiating site budgets and investigator contracts with legal support
- Potentially managing clinical vendors (labs, IP, patient diary, home health care) in conjunction with PM
- Potentially performing clinical data review and query generation
- May have line management responsibilities for supervised staff
The role requires strong communication and interpersonal skills, excellent organizational abilities, attention to detail, and a customer service orientation. Travel domestically and internationally, including overnight stays, is required.
**Requirements:**
- Bachelor's degree or equivalent combination of education and experience in a science or health-related field (Advanced degree preferred)
- Minimum 5–8 years of clinical research experience with significant clinical monitoring experience
- Experience in Phase 1 First-in-Human (FIH) and healthy volunteer clinical trials
- Mandarin language proficiency required to support Mandarin-speaking clients
- Proficiency with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
- Excellent communication and interpersonal skills
- Excellent organizational skills, attention to detail, and customer service demeanor
- Ability to travel domestically and internationally including overnight stays
