Job Overview: + Lead core project team(s) and facilitate team's ability to lead extended/complete project team. + Responsible for provision of client deliverables on-time, within budget and scope and with required quality for assigned projects or program. + Develops strategies to control and improve financial margin and minimize write-offs across projects and/or programs while maintaining quality. + Proactively identify out of scope activities, execute necessary change orders and support neg...

Job Overview: Biostatistics lead for large global or other major projects. Provide statistical input into other disciplines’ activities and participate in interdepartmental processes. Provision of technical solutions and advice to Covance staff and to clients on statistical methodology and principles. Supervision of less-experienced biostatisticians within project activities. Ensure mechanisms in place to maintain flow of appropriate information between disciplines on project team. Training and ...

Job Overview: The Associate Director's function is to oversee and direct multiple project concurrently [and/or programs, or mega studies as assigned] globally. Responsibilities typically include developing study strategy and costing in cooperation with other departments and the PMO. Additionally Project Directors develop and manage project teams, guide team communications, risk, scope, schedule, cost, quality and stakeholder management to effectively ensure plans are proactively and effectiv...

Job Overview: Are you an exceptional Clinical Research Associate (CRA) based in Taiwan that has independent trial site monitoring experience and would like to experience working as a CRA at a pharmaceutical company while remaining a permanent employee of Covance? Our Flexible Solutions Clinical Research Associates are based at our pharmaceutical client sites and manage all aspects of study site monitoring according to Client SOP, GCP, and ICH guidelines, including pre-study qualification and ini...

Job Overview: Act as the lead contact with investigative sites during assigned site start-up activities Oversee timely collection of the required investigator and regulatory documents for a study as specified by regulatory authorities and sponsor. Ensure the ongoing accuracy and quality of site/study documents. Ensure high quality documents are filed in (e)TMF and systems are updated on an ongoing basis ensuring Covance is audit ready at any time. When applicable, work with staff in Business Dev...

Job Overview: We are hiring Core Team CRA in Covance Taiwan Major responsibilities: Responsible for all aspects of study site visits and site management and monitoring activities ex. f/u SAE, clinical supply, etc Prepare accurate and timely trip report review progress of projects and initiate appropriate actions to achieve targets feasibility work, site selection, EC submission, RA submission, translation of study documents, negotiate study budget, contract Education/Qualifications: University d...

上海市 Job Overview: Organizes and conducts routine and non-routine processing in compliance with applicable methods, protocols, SOPs, and regulatory agency guidelines. Documents work and maintains study documentation and laboratory records. Sets up, operates and performs routine and non-routine maintenance on general equipment. Provides input and participates in project meetings, plans, monitors and guides project work. Performs QC review of data. Informs Study Director, Principal Investigator and...

Job Overview: Clinical Research Associate performs site management, site administration and site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files. Responsibilities and duties include, but are not limited to the following: Take charge of all aspects of Site Management as prescribed in the ...

Job Overview: Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to: entry of safety data onto adverse event database(s) and tracking systems review of adverse events for completeness, accuracy and appropriateness for expedited reporting write patient narratives code adverse events accurately using MedDRA determine expectedness/listedness against appropriate label identifies clin...

Job Overview: Assist in the development and implementation of solutions to global technical service issues and concerns regarding Medidata RAVE and Oracle InForm Complete assigned work utilizing Medidata RAVE or Oracle InForm or other proprietary software according to Covance SOPs, Work Instructions ,and project specific guidelines in accordance with Good Clinical Practices With assistance, meet with data manager on assigned projects to discuss contractual obligations and timelines Participate i...

上海市 Job Overview: Company Focus Contributes to and may lead the development of Company policies involving medical, safety and therapeutics Participates and leads in process improvement activities across Company Performs other duties as assigned Client Relationship & Business Development Activities Partnering with GCO to develop new and enhance existing client relationships where possible Provides leadership and presents medical/scientific capabilities to clients as a participant of a proposa...

大连市 Job Overview: Assist in the development and implementation of solutions to global technical service issues and concerns regarding EDC tools like Medidata RAVE, Oracle InForm and SAS programming. Read, understand and program EDC objects/SAS programming as per the specification documents which meets client requirements and projects. Perform any post production changes to the EDC data base or enhancements to the SAS programs like SAS edit checks, listings, etc. Work on EDC edit checks, DB desig...

上海市 Job Overview: Performs protocol, data, report, and in-lab phase inspections for specific study types to verify conformance to applicable SOP and regulatory requirements . Evaluates responses to inspection reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution. Ensures that systems used in QA are properly maintained (e.g., QA audit records, training records). Performs SOP reviews as appropriate Notifies management of service failures. Manages a...

Job Overview: Leads the conduct, reporting and follow up of regional and local QA audits, ensuring compliance to applicable SOPs, Master Audit Plan, and within specified timeframes and quality standards Conducts complex, directed, and/or time sensitive QA audits Participates in global QA audits Provides suitable recommendations for audit observations; ensures auditees deliver appropriate CAPAs and follows them up through closure. Escalates, as appropriate, where resolution of audit findings is i...

Job Overview: Analyzes biological or chemical samples and/or develops/validates methodologies for various compounds and components in compliance with standard operating procedures (SOPs) and regulatory agency guidelines. Duties and Responsibilities: Organizes and conducts routine analyses in compliance with applicable methods, protocols, SOPs, and regulatory agency guidelines. Maintains study documentation and laboratory records. Sets up, operates and performs routine and non-routine maintenance...

Job Overview: Analyzes biological or chemical samples and/or develops/validates methodologies for various compounds and components in compliance with appropriate standard operating procedures (SOPs) and regulatory agency guidelines. Duties and Responsibilities : Organizes, conducts and evaluates analytical results and testing. Maintains study documentation and laboratory records. Independently sets-up, maintains, operates and performs routine and non-routine maintenance on general equipment, inc...

Job Overview: Lead core project team during study start up phase and facilitate team’s ability to lead extended/complete project team. Depending on size and scope of project, this job duty may be performed in collaboration with a Senior Project Manager and/or Project Director. Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services. Resolve conflicts as needed. Monitor project schedule and scope to ensure both remain on track....

上海市 Job Overview: Commercial Acumen Has a deep understanding of the industry, market and our clients and presents Covance’s capabilities to clients. Leads growth within the assigned clients Owns assigned client relationships, expectations and satisfaction; serves as the subject matter expert within Covance on the client, guiding teams in building long-term strategic relationships with assigned clients Work closely with business development and other Covance business units to drive high quality e...

上海市 Job Overview: Essential Functions Perform assigned clinical laboratory testing accurately and in a timely manner. o Resolve pendings. Retrieve and check specimens against pending list. Document specimen discrepancies. Notify laboratory management when specimen discrepancies are not resolved. o Prepare workstation and instrumentation for the assigned testing. o Properly handle specimens and independently resolve technical specimen issues in preparation for analysis and specimen storage. Conta...

上海市 Job Overview: The Associate Director of Global Regulatory Affairs - China will work closely with sponsor companies in developing regulatory strategies that will support drug development initiatives in China. This responsibility will include leading client interactions with the NMPA. This position will also work as an internal consultant/advisor across various Covance business units to facilitate dialogues with our clients to develop relevant regulatory strategy and tactic plans to meet their...