Precision Medicine Group
Life Sciences
ClinicalTrialManager
Neural analysis suggests this role is
optimal for Manager candidates.
“Clinical Trial Manager at Precision Medicine Group. Skills: Clinical trial management, Protocol adherence, Regulatory compliance. Serve as clinical trial lead. Plan clinical studies”
Industry & Context.
Risk identification; Problem resolution
What They're Looking For.
Must Have
Bachelor's degree or equivalent, 5-8 years clinical research experience, Significant clinical monitoring experience
Nice to Have
Advanced degree preferred, Oncology (Phase I) trial experience in Taiwan and China preferred
What You'll Do.
Serve as clinical trial lead
Plan clinical studies
Conduct clinical studies
Oversee clinical studies
Ensure protocol adherence
Ensure regulatory adherence
Act as primary clinical point of contact
Collaborate on invoicing
Manage clinical budget variance
Develop study related documents
Identify training needs for CRAs
Identify training needs for vendors
Present at Investigator Meetings
Present at Study Kick-off meetings
Generate potential site list
Drive site feasibility process
Identify risks to enrollment targets
Develop country recruitment strategy
Develop country retention strategy
Develop communication with investigators
Develop relationships with investigators
Ensure effective site feasibility
Ensure effective site start up
Ensure effective enrollment
Ensure effective site maintenance
Ensure effective site close out
Lead internal clinical team meetings
Set expectations for clinical team
Address CRA questions
Address site questions
Support investigator meetings
Review IP release packages
Approve IP release packages
Oversee submissions to Competent Authorities
Oversee approvals to Competent Authorities
Oversee submissions to IRB/Ethics Committees
Oversee approvals to IRB/Ethics Committees
Develop clinical monitoring strategies
Assure study timelines are met
Assure quality deliverables
Generate metric reporting
Utilize metric reporting
Ensure study is conducted per plan
Communicate issues to PM
Communicate issues to CRAs
Assist sites with GCP audits
Assist internal staff with GCP audits
Assist CRAs with GCP audits
Address project-specific resourcing issues
Escalate CRA performance issues
Escalate site compliance issues
Ensure compliance with data cleaning timelines
Manage investigational product processes
Manage drug accountability
Manage drug reconciliation
Assume project management responsibility
Support business development activities
Support marketing activities
Negotiate site budget
Negotiate investigator contract
Review site visit reports
Ensure monitoring is executed per plan
Manage clinical vendors
Perform clinical data review
Manage workload of supervised staff
Perform other duties as assigned
How You'll Work.
Team & Collaboration
Internal clinical team; CRAs; CTAs; Data management; QA; Regulatory departments; Legal department; Site contracts group
Communication Scope
Presenting at meetings
Process & Methodology
Project management
Full Job Description
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
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