PPD is proud to employ over 20,000 employees worldwide, across 47 countries and 89 offices. In just over 30 years, PPD has grown to become a leading U.S. based CRO and recently has won accolades for industry leading CRA team, employee training & development, excellence in service and numerous awards for Best CRO. Our sustained year on year growth means that we are always looking for exceptional clinical talent to join our company.
Since opening in 2007, PPD’s offices in China now include 20 different departments. The combined Beijing and Shanghai offices are now seven times the size they were two years ago and are continuing to grow. In 2018 alone, the Clinical Management team is expected to triple in size. PPD China is able to offer our staff opportunities to collaborate on projects not only in Asia Pacific, but in regions around the world. You’ll have the opportunity to work on multinational trials—with top-tier sponsors, and on an industry-leading platform.
- Manages all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects.
- Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
- Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.
- Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitors or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
- May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
- May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensures that essential document quality meets the expectation of Regulatory Compliance Review. Reviews and follows up on all questions raised by the ethics committees.
May provide input into preparation of forecast estimates for clinical
activities. Responsible for clinical resource management, assignment, delegation of clinical
responsibilities and identification of additional resource requirements.
- Bachelor's degree or licensed certified health care training or equivalent combination of education and experience
- Previous oversight management activities in excess of 6 months e.g. as STM/ PM or one year of proven delegated management activities
- Clinical research experience in all phases of study life cycle, including start up, interim and close out
- Willingness to cross-region and in region travel according to the project needs
- Be competent in use of written and oral English language
Knowledge, Skills and Abilities:
- Superior organizational skills
- Strategic thinking skills
- Demonstrated performance management abilities
- Extensive monitoring experience
- Excellent judgment and decision making skills
- Excellent interpersonal skills and problem solving ability
- Highly effective verbal and written communication and presentation skills
- Ability to motivate and integrate teams and teach/mentor team members
- Expert knowledge of relevant regulations e.g. ICH/GCP, FDA guidelines, etc.
Our offer: As a compensation, you will be provided with a competitive remuneration, corporate trainings and the opportunity to become a part of a fast growing, multinational company. At PPD, we encourage our employees to demonstrate creativity, innovation and fresh insights as well as a solution-focused approach. We also value teamwork, camaraderie and enthusiasm. This is a full-time, permanent position.
Office based in Beijing, Shanghai, Guangzhou, Shenyang
Home based other locations in China