Work Flexibility: Hybrid

Medical Writing

• Perform formal literature searches, and succinctly summarize scientific content for assigned projects.
• Participates in post-market surveillance activities by conducting routine systematic literature reviews (e.g. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical device groups or sub-groups.
• Authors integrated safety/performance data summaries and reports including China Clinical Evaluation Reports, etc per regulation requirements
• Authors the preparation of Pre-/Post-Market Clinical Study documents and other medical writing efforts including but not limited to Clinical Investigational Plan, Clinical Study Reports, etc.
• Authors evidence generation initiatives, incl. Journal Clubs, Scientific Communication newsletters, etc.
• Supports the response to Deficiency Letters from NMPA
• Challenges conclusions when necessary. Independently resolves document content issues and questions from external and internal reviewers and ensures timely approvals from all approvers.
• Delivers high-quality deliverables and require limited revision rounds including Pre-/Post-Market Clinical Study documents, and other medical writing efforts, etc.
• Provides in-depth readings into clinical evaluation regulations, technical guidance, and medical device regulations etc. as required.
• Works on other tasks and projects as assigned.

Clinical Operations

• Primary point of contact with site staff, and is responsible for managing the site throughout all phases of the clinical study, including selection and initiation of sites, as well as conducting and closing activities of the appointed studies.
• Administers protocol and related study training to assigned sites, evaluates the quality and integrity of study site practices related to proper conduct of the protocol and adherence to applicable regulations.
• Manages the progress of assigned studies by tracking regulatory submissions and approvals, study enrollment, data completion and submission, as well as resolution of data discrepancies.
• Creates and maintains appropriate documentation regarding site management, monitoring visit findings and action plans. May serve as subject matter expert in audits.
• Verify that the research site personnel, including the investigators, are conducting the study according to the clinical protocol, “Good Clinical Practices”, and regulatory requirements
• Ensure reporting of adverse events from research site staff to the sponsor and the IRB/IEC
• Verify that the data in the Case Report Forms (CRFs/eCRFs) are in agreement with the source documents (source data verification)
• Review accuracy and completeness of site records (site study file, query resolution, and other data collection tools)
• Verify Investigational Product accountability
• Complete reporting and ensure management and resolution of all these activities (e.g., visit reports, trial management tracking system, pre-confirmation letter, follow-up letter, etc)
• Conduct routine monitoring visits on behalf of the clinical trial sponsor.
• Prepare informed consent documents
• Completes clinical project deliverables per schedule
• Ensures audit-readiness for assigned study sites
• Communicates relevant information to the PM/LCRA in a timely manner
• Contacts sites on a consistent basis to assess study compliance
• Identify and address noncompliance issues at investigative sites, assist with CAPA, if necessary
• Tracks Screening & Enrollment and identify issues and propose solutions.
• Participates in the conduct and training at Investigator Meetings.
• Maintains expertise in regulations for China and different types of studies (pre-market, post-market, etc).
• Generates status reports, oversees process payments, maintain device and regulatory document tracking systems, patient and Case Report Form (CRF) files, required regulatory documents, and central files.
• Collects and tracks regulatory documents (e.g., confidentiality disclosures, IRB approvals, investigator agreements, contracts, study/project annual reports and financial disclosures) to/from study sites using company specific database
• Reviews and collects documents to compile Clinical Events Committee (CEC) packets for CEC adjudication meetings
• Recommends process improvements to increase team efficiencies and effectiveness.
• Supports eTMF maintenance to ensure timely document archival

• Works on other tasks and projects as assigned.

Travel Percentage: None