A historic pharmaceutical company is seeking to recruit a Sales Account Manager to their office in Shanghai. The organisation creates informative and engaging online communities that share information in meaningful ways. This vacancy offers an exciting opportunity to work with a leading and innovative pharmaceutical organisation that develops high quality medicines that meet real needs.
- Provides the single point of requirements definition (collection, validation and delivery), strategy communication, and deliverable acceptance to the vendors executing delivery of clinical data management.
- Provides single point of accountability and deliverable ownership for all aspects of clinical data management.
- Acts as the primary contact to the study team and program team members for data science and data solution application.
- Acts as a primary contact within the Data Sciences & Solutions organization for all data issues related to assigned trials and molecules.
- Applies specialized therapeutic knowledge and data management discipline knowledge to ensure database deliverables are consistent, accurate, adherent to the data strategy, and deliver the clinical, statistical, regulatory, and business demands of the team.
- Develop, communicate, and drive implementation of China data strategy aligned with the glob al clinical plans for a data asset (molecule, therapeutic area, data domain, etc.) throughout its lifecycle, including early development, globalization and commercialization, scientific data disclosure plans, brand council, external dataset, etc.
- Focus on understanding and guiding organization to support China regulatory domains. Activities include lobbying efforts internally across functions and externally with regulatory authorities, confirming all regulatory data submission needs from DSS are met, and accelerating the submission timing in key markets
- Develop and ensure that deep knowledge of internal, external and regulatory requirements/ expectations in China relevant to the data domain are understood, well communicated, and applied to data deliverables and global data strategy, and influence external organizations to further company's interests in the industry.
- Proactively drive the use of data processes and tools to accelerate the development of a data asset. Bring greater value to the portfolio by anticipating issues and identifying opportunities for which data solutions can be applied.
- Define company business requirements for the study/program for vendors to deliver.
- Ensure that data management deliverables are delivered to scope, cost, and time objectives.
- Execute project monitoring and quality oversight of sourcing providers for end-to-end data management activities from study set up through trial execution through dataset delivery.
- Ensure vendor performance for the program-level flow of data, including across niche vendors and niche data sources.
- Drives data flow design through consultation, review, and approval of vendor work. Ensures the data flow design is aligned with the project hypothesis
- Approve key deliverables (i.e. Data Quality Delivery Plan, Data lock Plan, Project Plan, data base, and observed datasets)
Skills and Requirements:
- Bachelor's degree or equivalent experience
- Minimum of 3 years' experience in clinical data management and/or 5 years' experience in drug development in areas intersecting with clinical data management (e.g., clinical operations, statistics, information technology, health outcomes, etc.).
- Articulate the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions.
- Decide the technology platform (system/database) for data acquisition and aggregation.
- Mandarin written and verbal communication capability.
- Clinical knowledge and an ability to liaise effectively with study team members (i.e. Data Sciences, Statistics, PK. Operations, Medical).
- Strong therapeutic/ scientific knowledge Project management experience.
- Vendor management experience.
- Virtual team environment experience.
- SCDM certification.
- Familiarity with clinical data tools and technologies.
- Technical know ledge to develop requirements and/or study/ project deliverables (i.e. SAS, Oracle).
- Experience in forms design and layout.
- Understanding and experience in using data standards.
- Knowledge of medical terminology Process management expertise.
- Domestic and International travel may be required.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Kirsty Zhuang at email@example.com or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.