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Main Accountabilities:
• Responsible for the business development activities to find business opportunities and cultivate client base,contribute to revenue increasing
• Generate,lead and close business for laboratory,clinical research and consulting & regulatory units
• Set up business development strategic plan,execute,follow-up and control accordingly
• Develop potential clients,effectively communicate features & benefits & capabilities of Amador Bioscience with clients,and maintain stable relationships with them
• Promote academic cooperation and exchanges with domestic and foreign pharmaceutical companies,responsible for preparation, organization and coordination for holding/participating in various external and internal meetings/ exhibitions
• Collect and disseminate accurate and complete information from clients to internal technical staff to understand the scope of work
• Work with operational staff to define project scope and combine with existing capabilities to generate the scope of work and provide timely price quotations/proposals
• Write and develop proposals and contract templates.
• Assists in reviewing, writing and negotiating contract terms and conditions
• Follows up on quotations for purposes of both gathering client feedback and expediting client decisions.
• Complete paper work (i.e., sales/call reports, quote requests, and expense reports) and updates Client Relationship Management (CRM) tool in a timely manner.
• Familiar with the domestic and international CRO research and development trends and global pharmaceutical market,and provide advice on the company's development direction and strategy development
Role Related Qualifications/ Skills:
• Bachelor’s degree or above, major in biology, medicine, pharmacy, etc. is preferred;
• 3-5 years of working experience in business development in biotech/biopharma industry, and a profound accumulation of clients in the pharmaceutical industry;
• Excellent at communication and negotiation, with good teamwork spirit;
• Familiar with domestic and foreign pharmaceutical companies, market status and development trends, strong market sensitivity, information capture capabilities and pioneering spirit;
• Good adaptability and can work under time constraints and task pressures;
• Honest and trustworthy, with a good sense of corporate image.
请将您的求职信和简历发送至 [email protected]
岗位职责:
岗位要求:
请将您的求职信和简历发送至 [email protected]
Amador Bioscience Inc. (“AmadorBio”) is a Contract Research Organization company providing high-quality integrated services in R&D consulting, bioanalysis, clinical trial management and regulatory submissions. AmadorBio strives for both high-quality results and a superior customer experience. Our clients include global pharmaceutical and leading biotech companies. AmadorBio operates in the San Francisco bay area and Shanghai-Hangzhou, biotech hubs in the US and China.
To meet the needs of business growth, we are looking for several Pharmacokinetic Associate Scientists or Scientist to join our passionate team. The primary function of a PK Associate Scientist / Scientist is to support clinical pharmacology consulting project leaders through all stages of new drug development cycle. He/she will be responsible for all aspects of PK-related support, including data evaluation, interpretation, reporting, and generation of manuscripts/abstracts for publication.
Education:
Experience:
Special Skills/Abilities:
请将您的求职信和简历发送至 [email protected]
岗位职责
任职要求
请将您的求职信和简历发送至 [email protected]
岗位职责
任职要求
请将您的求职信和简历发送至 [email protected]
ROLE AND RESPONSIBILITIES
• To establish pharmacokinetics consulting function in China; Lead or contribute to business development strategy, client interactions, talent recruitment and publication/promotion.
• Performing noncompartmental analysis for nonclinical and clinical studies; authoring and /or reviewing relevant documents including protocols, analysis plans, reports and regulatory documents; in collaboration with other functional groups contributing to regulatory submission packages.
• Providing strategic advice to clients and developing product development strategic plans.
• To ensure PK deliverables meet agreed timelines and budget, and all related operations and procedures in compliance with protocol, Amador’s SOPs, ICH-GxP and applicable local regulations.
• Contributing to functional excellence in science, including quantitative pharmacology, population modeling and simulation, and regulatory science.
• Providing input and direction on development of client network and promoting service excellence and expansion to clients.
• Leading, developing and implementing operational initiatives that enable Amador to compete more vigorously in a constantly changing and demanding marketplace.
QUALIFICATIONS AND EDUCATION REQUIREMENTS
Education:
• A master or doctorate degree in pharmaceutical sciences, medicine, engineering, chemistry or other relevant scientific fields.
Experience:
• PhD with 2+ years or MS with 6+ years of relevant experience in biopharmaceutical development or regulation
Special Skills/Abilities:
• Prior experience with PK data analysis and reporting is required.
• Strong analytical and technical writing skills are required for this position.
• Good communication, managerial and organization skills are essential.
• Demonstrated capability to lead teams is desired
请将您的求职信和简历发送至 [email protected]
岗位职责
任职要求
请将您的求职信和简历发送至 [email protected]
Main Accountabilities:
Role Related Qualifications/ Skills:
请将您的求职信和简历发送至 [email protected]
Main Accountabilities:
Role Related Qualifications/ Skills:
请将您的求职信和简历发送至 [email protected]
Main Accountabilities
Role related Qualifications/ Skills:
请将您的求职信和简历发送至 [email protected]
Main Accountabilities:
• To ensure all related clinical research operations and procedures are in compliance with protocol, Amador’s SOPs, ICH-GCP and applicable local regulations.
• To be able to contributre to the study site selection process by preparing feasibility questionary and perform the initial site contacts through phone calls and site interviews.
• To be responsible for clinical study sites selection and to ensure these sites can meet the Reistone’s requirements and qualified with FDA.
• To be responsible for clinical trail start-up at sites, include complete GCP submission, obtain the EC approval, contract negociation and sign-off.
• To be responsible for initiating, monitoring and closing the clinical study sites and submit the visit reports on time.
• To be responsible for submitting documents to site GCP office & EC correctly and on time.
• To ensure storage, distribution, return IMP/NIMP at the sites and report of deviations in compliance with protocol, Reistone’s SOPs, ICH-GCP and applicable local regulations.
• To be responsible for using CTMS or required system and trackers in clinical trial and ensure information entered into CTMS or required system and trackers is accurate and updated regularly
• To ensure AEs/SAEs are recorded correctly and reported approprately according to timeline stipulated in clinical study protocols and current regulation.
• To ensure the study sites update and maintain essential documents in Investigator Site Files correctly and on time.
• To be responsible for transfer Amadorstudy essential documents to TMF on time and consist with ISF.
• To build and keep good working relationship with clinical study sites.
• To be able to complete the above tasks independently with satisfaction, and coach the junior team members in their training and daily activities.
• To conduct co-monitoring visits and perform internal quality control to the assigned studies.
• To develop various study specific forms/templates and prepare/manage study status reports
• To contribute to the review of all SAEs, ensure medical monitor sign-off, site notification and compliance with all company precedures.
• To contribute to the database lock by participating in data listing review.
• To be able to develop and maintain basic working process of relevant studies and assist in the coordination of the assigned study/project and perform other team duties as required or delegated by the CPM.
Role Related Qualifications/ Skills:
• 3-4 years of CRA experience in a CRO or pharmaceutical & medical device compamy.
• Bachelor’s degree or above in Medical, Pharmacy or related areas.
• Comprehensive knowledge and understanding of ICH-GCP and applicable local regulations.
• Excellent in communication skills and is expected to establish good relationship with the Investigators and other related site staffs.
• Fine written, verbal skills, and presentation skills
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Role and Responsibilities
• This individual will be responsible for aligning/merging data sets, apply binding codes, and preparing merged data sets for pharmacokinetic/pharmacodynamic analysis and modeling.
• Generating tables and listings accounting for the disposition of patients and samples, descriptive statistics of pharmacokinetic variables, and results.
• Creating figures to include but not limited to: drug concentration over time, pharmacokinetic parameters over dose, concentration-effect relationship, and efficacy/safety analyses.
• Contributing to the clinical study reports and regulatory submissions
• Collaborating with project leaders and statisticians on study protocol design and lab data evaluation (eg ADA cutpoint)
Role Related Qualifications/ Skills:
Education:
• BS or MS degree in pharmaceutical sciences, biological sciences, Statistics, Mathematics, Chemistry or other relevant scientific fields.
Experience:
• Basic understanding of biostatistics
• Experienced in data analysis
• Able to take directives and work independently
• Excellent problem solving skills
• Excellent interpersonal skills
• Proficient in SAS programming.
• Basic to advanced understanding of "R"
• Proficient in Excel and Excel macro generation.
• Basic understanding of pharmacokinetic principals and some exposure to WinNonLin and/or NONMEM is a plus
• MS in Statistics, mathematics, engineering or relevant fields
请将您的求职信和简历发送至 [email protected]
Main Accountabilities:
• Responsible for ensuring the completeness quality and integrity of the subject data in the clinical trial database
• Responsible for data management activities within a clinical trial according to regulations applicable Standard Operating Procedures (SOPs) and Processes
• understanding key processes and principles associated with role including CRF design, database set-up, edit check specification, DMP and data cleaning activities.
• Review protocols to ensure the data collection, database and reporting requirements can be met and are standardized across the program
• Accountable for the implementation of data activities including Study Startup, Data Acquisition, Standards and Discrepancy Management for the responsible studies.
• Reconcile the patient database with the Serious Adverse Event database
• Document all efforts of data management and file all responsible documents
• Works independently receives instruction primarily on unusual situations
• Ability to organize multitasks prioritize and deliver on time
• Ability to communicate effectively and appropriately with internal external stakeholders
Role Related Qualifications/ Skills:
• Bachelor’s degree or equivalent in a natural/medical science data management or related discipline
• Demonstrated basic knowledge of data management processes and principles in area of responsibility
• Demonstrated basic knowledge of Windows Environment and its applications (Word Excel PowerPoint Project etc.)
• Good learning capability self-motivated on adopting learning into practice under supervision towards working independently on routine responsibilities
• 3-5years of data management experiences
• Demonstrated good English comprehension skills both reading and writing
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Main Responsibilities:
• Design, create and test clinical database to ensure data collection tools and databases align with the protocol and adhere to GCP, SOPs, corporate standards and regulatory
• Performs database set up according to annotation CRF (aCRF) and Database Structure Specification.
• Updates database following the database User Acceptance Test (UAT)
• Develops the System and SAS Edit Checks according to Data Validation Plan (DVP)
• Updates System EC following the EC UAT results
• Develops data management report in Clinical Database System.
• Develops SAS programs to produce data listings and reports for data reviews.
• Understands and complies with core data management operating procedures and working instructions.
• Develops and maintains good communication and working relationships with CDM team.
• Performs other activities as required
Role Related Qualifications/ Skills:
• Bachelor’s degree in computer science/statistics or related field
• Skills in database design, database structure and programming languages
• Hands on SAS skills in Base SAS, Report.
• 3-5 years of database development and programming. At least 2 to 4 years’ experience with Medidata RAVE database
• Proficient verbal and written communication skills, both in Chinese and in English
• Experiences in health care, pharmaceutical or CRO industry
• Leadership, verbal and written communication