HireDiversity

Beijing, CN

Senior Site Manager-000009B3

Description

Study Planning/set-up activities
- When required, assist LTM to conduct site feasibility
- conduct Pre-trial visits to assess the investigational staff and facilities
- Discuss the items listed on the PAR with the investigator and other appropriate staff
- Review the site commitment in detail with the investigator
- Develop/adapt recruitment and retention strategy for the site
- Ensure all required trial-related materials and supplies are provided to the investigational site
- Ensure that the investigators send the SUA gap pack to the IEC/IRB, when the sponsor is not responsible for sending safety information to the IEC/IRB
- Set up the IF and TCF
- If needed, development of site-specific ICF
- Ensure that the investigational staff are instructed on the requirements for proper informed consent
- When local Ethics Committees are used, ensure that the IEC/IRB is provided with current and complete copies of all documents that the IEC/IRB requests to fulfill its obligation and obtain a copy of the valid written IEC/IRB approval and all related required documents, including the composition of the IEC/IRB
- Obtain site related trial documents and review them for completeness and accuracy
- Negotiate investigator budgets at site level and track the status of site CTA
- Plan and conduct investigator and site-staff training
- Conduct site initiation visits
- If applicable, execute the user acceptance testing plan
- If applicable, create site specific and monitoring tools

Monitoring activities
- Notify the GTM and the Local CSC in writing, when a country and an investigational site is approved to receive clinical drug supplies
- At the investigational site, ensure clinical drug supplies are available, appropriately used, handled, stored (e g , temperature logs, security), and returned, accurately inventoried and documented. Inform the investigational staff of the distribution process
- Conduct monitoring visits according to the checklist of activities listed on the Monitoring Visit Report
- Report to LTM on study site status through monitoring report and meetings
- Document all study related communications
- Perform SDV to ensure accurate data is recorded based if required
- Follow up with the trial site(s) regarding completion of case report forms and data correction forms within required timeframe
- Ensure that all AEs/SAEs/PQCs are reported within reporting timelines and documented as appropriate. For AEs/SAEs ensure they are consistent with all data collected and with the information in the source documents
- Ensure that the investigators send the safety reports to the IEC/IRB, when the sponsor is not responsible for sending safety information to the IEC/IRB
- Arrange for the appropriate destruction of clinical drug supplies
- Ensure that the investigational staff stores the randomization codes in a limited access area that is accessible 24 hours a day and instruct them on the code-breaking procedure
- In studies where IVRS/EDC are used, ensure that the IVRS/EDC at the site work smoothly during the study.
- Track costs at site level and ensure payments are made with planned payment schedule
- Ensure TCF is maintained as required and maintain IF
- Ensure subject commitment per site is met
- Conduct site closure visit according to the checklist activities listed on the site closure report
- If applicable, remind the investigator to notify the IEC/IRB of the site closure
- Ensure the IF is complete and accurate
- Provide study report synopsis to investigators, IEC/IRBs
- Check the Site details on Appendix 1 documents and provide feedback to the LTM
- Follow up on and resolve any pending issues, including adverse events and IFDFs one year post-trial

General activities
- Represent the company and the organization adequately to the customers and other external parties
- Base all actions on Credo
- Protect the rights of others, protect privacy and company assets, particularly information as the key asset
- Conduct business in line with the HCC, company policies and procedures, including applicable SOPs, always having the ethical aspect in mind
- Maintain adequate communication with relevant parties within and outside the company
- Comply with ICH-GCP and all applicable local laws and regulations
- Actively follow trainings to ensure adequate qualification for performing job-related tasks
- Report (suspicion of) fraud or scientific/ethical misconduct as appropriate
- Regularly update information in applicable systems and templates
- Contribute to the development and improvement of departmental procedures and processes and templates in the scope of the company's effort towards continuous quality improvement
- Maintain quality standards and timelines that are consistent with business needs

Qualifications


A. Education /Training background:

Bachelor degree, background of medicine or pharmacy is preferred

B. Knowledge/Skills:

Well familiar with ICH GCP, GCP of China and applicable regulations

Well familiar with procedures of clinical R&D and regulation application

C. Job experience:

3 years clinical study experience.

Working experience in international pharmaceuticals or CRO

D. Competency:

Good communication, team working, problem identifying and solving abilities

E. Others:

Good english ablities of listening, speaking, reading and writing; same level of CET-6 or above

Primary Location:Asia Pacific-China-Beijing-Beijing
Other Locations:Asia Pacific-China-Shaanxi-Xi'an
Organization: Xian-Janssen Pharmaceutical Ltd. (7043)
Travel:Yes, 25% of the time
Job Function: Clinical Trial Administration