associate岗位职责

Position overview:
Working as an Clinical Research Associate is ultimately responsible fthe successful management of investigatsites throughout the
trial lifecycle. Key responsibilities include:
• Full ownership of investigatsites fassigned studies with responsibility fthe successful management of the site right through to close-out.
• Planning conducting various site visits (feasibility, site selection, interim close-out) in accordance with the clinical monitoring plan.
• Developing effective relationships with investigatsite staff to ensure that key clinical metrics are met.
• Preparing fattending investigatmeetings, coordinating the timely shipment the subsequent proper storage accountability of clinical supplies following-up of drug safety issues.
• Ensuring integrity of clinical data through an ability to sufficiently maintain site tracking records work diligently to relevant guidelines
You will receive the support you need to develop personally professionally work in an environment where you matter. Our team pushes forward together.
United in solving problems, developing close site relationships reaching the end goal. Operating as a key part of a global study team, the CRA plays a fundamental role in our clients’ drug development processes.
You are:
Dedicated, collaborative inspire others.
Here we want our employees to succeed ensure that they are set up fthis success through constant training, development support. To enable success in this position you will have:
• Priexperience of working in investigatsite management, including conducting monitoring visits, from either a pharmaceutical company a CRO environment.
• A working knowledge of ICH-GCP guidelines local international regulatory requirements is essential.
• You will be educated to degree level, have equivalent experience be a licensed healthcare professional.

此职位为海外人才储备岗位，可接受长期外派到马来西亚或越南工作，前期需在国内公司公司工作/培训半年及以上。
TASKS RESPONSIBILITIES:
1. Follow the clinical trial protocol, design CRF.
2. Develop Data Validation Specification based on protocol CRF.
3. Set up EDC system perform UAT.
4. Perform Data Entry.
5. Perform clinical data cleaning (Data Review, Query Management, ExternalDataReconciliation, etc.).
6. Perform Raw Data Transfer.
7. Responsible flocal lab normal range management.
8. Manage EDC system user accounts.
9. May use SAS programs to perform data Edit Check Listing on Raw data to find Raw dataissues.
10. Work independently, as while as being a team member working with other data managers,programmers statisticians.
11. Perform other duties as directed by management senipersonnel.
JOB REQUIREMENTS:
1. Candidates must be fluent in both Chinese English, with a bachelors degree higher in medicine, pharmacy, a related field.
2. Proficiency in R/Python/SAS is a plus.
3. Strong teamwork skills, ability to work under pressure, a high sense of responsibility are required.

此职位为海外人才储备岗位，可接受长期外派到马来西亚或越南工作，前期需在国内公司公司工作/培训半年及以上。
TASKS RESPONSIBILITIES:
1. Follow the clinical trial protocol, CRF, SDTM specification CDISC guideline to convertraw data to SDTM, validate SDTM datasets, maintain SAS programs, package deliverablesdocument all SDTM/Raw Data related issues.
2. Develop SDTM data spec, define, CRF annotation etc.
3. Use SAS program to perform data comparison fdifferent data transfer batches identifyrelevant changes if necessary.
4. Manual data check on SDTM datasets to make sure the raw datasets are converted successfully without any mistakes.
5. Use Pinnacle 21 other tools to correct deviations.
6. Develop Patient Profile perform rerun.
7. Work independently, as while as being a team member working with other statistical analysts statisticians.
8. Perform other duties as directed by management senipersonnel.
JOB REQUIREMENTS:
1. Candidates must be fluent in both Chinese English, with a bachelors degree higher in medicine, pharmacy, a related field.
2. Proficiency in R/Python/SAS is a plus.
3. Strong teamwork skills, ability to work under pressure, a high sense of responsibility are required.