上海招聘

Responsibilities

  

• Data Management Lead ? Responsible for the role which includes the management and maintenance of clinical data and interfacing with clinical teams. Provides leadership and content expertise for clinical data management activities from start-up through statistical analysis stage of clinical studies to effectively manage data capture, review, and database lock activities.
• ? Member of the protocol review team, CRF review team, medical safety monitoring plan reviewer, member of the clinical study report review team, and may perform peer review of clinical data management deliverables as a peer Data Management Lead.
• ? In addition, the incumbent is the key contact for statistical sciences and programming (SSP), global clinical trial management (GCTM), global site management operations (GSMO), global patient safety and epidemiology (GPSE), clinical development, and non-translational sciences (NTS).
• ? External Vendor Manager ? Responsible for the role which includes participating in the vendor selection process and managing vendors (eg. CROs, FSPs, technology providers, etc.) in accordance with applicable Allergan processes and procedures. Involvement in assessment/re-assessment of vendor capabilities, as necessary. In addition, the incumbent is the key contact for R&D sourcing and clinical vendor oversight (CVO).
• ? Process Owner/Subject Matter Expert ? Responsible for the role which includes the implementation of quality, efficient, and consistent approaches to carrying out clinical data management tasks. Drives and contributes to
  

  

continuous improvement. Delivering training to clinical data management and other functions/departments as necessary. Monitors compliance to controlled procedural documents (eg, SOPs) and proactively addresses gaps in processes or understanding of processes by clinical data management staff. Supports corrective and preventative (CAPA) action initiatives as needed.
• ? Is the key contact for process, training, and continuous improvement (PTCI) and global research and development quality (GRDQ).

Qualifications

• ? Bachelor’s Degree with demonstrated ability in clinical research, computer science, project management or related field.
• ? Strong knowledge of research and development, clinical trials execution, and understanding of regulatory requirements/guidelines (e.g. ICH, GCP, safety reporting).
• ? Strong knowledge and understanding of regulatory guidelines for the use of computerized systems in clinical trials.
• ? Strong knowledge of global standards related to clinical data management activities (data standards, database design, coding and coding dictionaries, etc.).
• ? Strong ability to work in a matrix environment and communicate effectively with different functional groups across the organization.
• ? Strong ability to foster open communication and practice active listening to encourage a collaborative team environment.
• ? Demonstrates a solution oriented approach to problem solving and a "can do" attitude.
? Ability to travel up to 15% of time.

 

 

RPS Inc. is a next generation global CRO, headquartered in the United States with the operations in 45 countries throughout Americas (US, Canada, Latin America), EMEA and Asia Pacific regions. RPS provides comprehensive global Phase 1-4 clinical development solutions to the pharmaceutical, biotechnology and medical device industries. By combining an experienced clinical research operations infrastructure with the industry’s largest resourcing engines, RPS is uniquely positioned to offer our Clients both integrated and full service global outsourcing solutions. These solutions are powered by highly experienced and seasoned study teams providing innovative, cost-effective and high quality services.


RPS Asia Pacific Headquarters is located in Beijing, China and we have operations in 11 Countries in Asia Pacific region. With the rapid organic expansion of RPS in China & Asia Pacific, we are continuously looking for the experienced industry talents to join us.


Our specialized staff of consultants is eager to discuss your career plans. Tell us about yourself experience, so the appropriate consultant can contact you. RPS is sensitive to your daily responsibilities. Tell us EXACTLY how to contact you and we will. For your convenience, you can also submit your resume. We look forward to discussing the opportunities and benefits of employment with RPS!


For more information, please visit our website www.rpsweb.com.