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Clinical Trail Coordinator-Beijing

Your role:

  • Support CTLs/ Trial Teams / COT for budget management, trial medication activities, special activities for vendor surveillance, budget forecast, surveillance of company compliance in trials/programs and building accruals as appropriate.
  • Knowledge and usage of databases and programs of the department.
  • Proficient in using financial tools / systems to create accurate financial documents.
  • Responsible for invoice processing and tracking in a timely manner.
  • Ensure that all financial documentation is audit readily for inspection at all time.
  • Review the Clinical Trial Management System (e.g. SWAN, Infosario) for any relevant details required. Ensure in conjunction with the CTL that all systems are updated on a regular basis.
  • Perform TMF vendor surveillance as appropriate. Communicate with CRO or other functions accordingly to ensure TMF inspection readiness at all time (under CTL responsibility).
  • Prepare and coordinate the process for the creation of legal documents for clinical trials/programs, e.g. Power of Attorney.
  • Ensure together with CTLs/ Trial Teams / COT that risk management for the corresponding trials / programs is established and updated on an ongoing basis together with the CRO.
  • Contribute to workshops / special initiatives as expert / professional for dedicated topics.
  • Prepare and hold presentations for training sessions, line managers meetings, department meetings, program or trial meetings as required.
  • Develop and maintain complex administrative systems / reports and formats.
  • Ensure all trackers are maintained in an up to date manner and available for the CTLs/ Trial Teams / COT to consult.
  • Support CTLs for Investigator Meetings, as applicable. Ensure that correct code of practice / compliance is adhered to by the CRO and relevant information is provided to assist this process.
  • Organize meetings that are not under the responsibility of the CRO, as required.
  • Assist in the development of and/or delivery of presentations, as requested.
  • In conjunction with the CRO, establish and maintain archiving according to ICH-GCP, company SOPs and WIs, as requested.
  • Assist the CTLs/ Trial Teams / COT in preparation of Audits or Inspections and participate in audit and inspection interviews, as required.
  • Assist in the set-up and follow-up of Corrective and Preventive Action Plans (CAPAs) associated with Audits, as requested.
  • Demonstrate ownership for all assigned tasks and demonstrate a willingness to build knowledge.
  • Take on additional tasks as assigned by management.

 

Who you are

EDUCATION/LANGUAGES

  • Secondary education with commercial or secretarial diploma(s) (or local equivalent) or higher degree.
  • Preferably science degree or biomedical degree.
  • Good oral and written communication in English.

PROFESSIONAL SKILLS & EXPERIENCE

  • Preferably 1-2 years working experience in a clinical research-related position.
  • Strong computer skills including knowledge of MS Office ™ (Excel™, Word™, PowerPoint™) and Lotus Notes™. Database skills is an advantage.
  • Ability to work with computer applications.
  • Good understanding of the policies and procedures of Clinical Operations and of ICH-GCP.
  • Good knowledge of medical terminology (and therapeutic areas).
  • Familiar with the responsibilities and needs of other functions in a clinical trial.
  • Experience working in a high-volume environment handling multiple tasks.
  • Strong administrative skills.
  • Preferable experience in risk management and audit / inspection readiness preparation.
  • Communication skills including working processes in English as the main business language, preferably experience in clinical trial management terminology.

PERSONAL SKILLS & COMPETENCIES

  • Good time and priority management skill, ability to work efficiently under pressure.
  • Reliable, conscientious and confidential.
  • Self-motivated, shows initiative, is proactive and able to work independently as well as in a team.
  • Good communication skills – both verbal and written.
  • Good interpersonal skills and ability to deal with people at all levels with sensitivity and tact.
  • Good organizational and problem-solving skills.
  • Willing to take on responsibility.
  • Ability to work in an international/ multicultural matrix environment.

 

HR95601

Function area: Global Research & Development

职位需求编号:  192216
位置:  北京 - 全部
职业阶段:  C - Professional (1-3 years)
工作时间模型:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


职位细分: Clinic, Medical, Inspector, Database, Healthcare, Quality, Research, Technology

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