SUMMARYI am currently helping for a medium sized global CRO looking for expanding their business in Asia Pacific and are now looking for a Senior Clinical Data Manager in ChinaThe Senior Clinical Data Manager will be responsible for overseeing and managing all aspects of the clinical trial data management process for assigned studies, from study start‑up through post–database lockRESPONSIBILITIES• Primary Data Management (DM) contact (Lead DM role) for assigned clinical project(s) / program(s), ensuring that there is back-up, continuity, responsiveness, and that tasks are performed in a timely manner. May support another Lead DM as a back-up and/or team member. May include DM oversight of sponsor programs. • Oversee project data entry process including development of data entry guidelines, training, data entry quality and resourcing • May perform quality control of data entry • Provide input, assesses and manage timelines. Ensure that clinical data management deadlines are met with quality. Assess resource needs for assigned projects, as needed. • Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders • May assist in building clinical databases • Conduct database build UAT and maintain quality controlled database build documentation. Oversee overall quality of the clinical database. • May specify requirements for all edit check types e.g. electronic, manual data review, edit checks, etc. Oversee development of the edit check specifications and manual data review specifications • Responsible for creating, revising, appropriate versioning and maintaining data management documentation. Oversee completeness of data management documentation for the Trial Master File. • Train clinical research personnel on the study specific CRF, EDC, and other project related items as needed. • Review and query clinical trial data according to the Data Management Plan • Perform line listing data review based on the guidance provided by the sponsor and/or Lead DM • Run patient and study level status and metric reporting • Perform medical coding of medical terms relative to each other in order to ensure medical logic and consistency • Coordinate SAE/AE reconciliation • Liaises with third-party vendors such as external data and EDC vendors in a project-manager capacity in support of timelines and data-related deliverables • May assist with SAS programming and quality control of SAS programs used in the Data Management department • Identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders • May assist in reviewing and providing feedback on protocols, Statistical Analysis Plans (SAP) and Clinical Study Reports (CSRs), if required by the project • Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities • May attend strategy meetings, bid defense prep meetings, bid defenses, capability presentations, potential client engagement meetings • May review Request for Proposals (RFP), proposals, provide project estimates • Provide leadership for cross-functional and organization-wide initiatives, where applicable • Trains and ensures that all data management project team members have been sufficiently trained • Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues • May present software demonstrations/trainings, department/company training sessions, present at project meetings • May require some travel • Perform other duties as assignedDURATIONPermanent, full-timeLOCATIONShanghai/BeijingABOUT PLANET PHARMAPlanet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.www.planet-pharma.comABOUT PLANET PHARMAPlanet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.www.planet-pharma.comTO APPLYPlease click ‘apply’ or contact Steven Fan (Recruiter, APAC) at Planet Pharma for more information:T: : +61 370427282Linkedin: https://www.linkedin.com/in/steven-fan-38a394128/

QUALIFICATIONS• 8+ years’ experience• Able to handle a variety of clinical research tasks• Excellent organizational and communication skills• Professional use of the English language; both written and oral• Experience in utilizing various clinical database management systems• Broad knowledge of drug, device and/or biologic development and effective data management practices• Strong representational skills, ability to communicate effectively orally and in writing