Local Trial Manager-1460651W
Description
1. Perform country and site feasibility and prepare country feasibility report. Define any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct appropriate follow-up of pre-trial visit report information. Recommend suitable sites for selection.
2. Lead and coordinate all local trial team activities in compliance with Company Standard Operating Procedures and applicable regulations. Conduct local trial team meetings. Lead local project planning activities to meet recruitment targets and to deliver high quality data on time and within budget. Including but not limited to: development of trial specific procedures and tools, recruitment planning, risk management, budget forecasts, resource forecasts. Maintain trial management systems up to date (e.g. CTMS, eTMF). Monitor trial progress and initiate corrective and preventative actions when the trial deviates from plan.
3. May be assigned to oversee outsourced studies.
4. Organize and ensure local HA approval and any import/export permits.
5. Review and approve regulatory document packages prior to site initiation in accordance with standard operating procedures.
6. Prepare country specific informed consent form templates. Review and approve site specific informed consent forms in accordance with standard operating procedures.
7. May lead negotiation of trial site contracts and budgets. Obtain and maintain relevant insurance.
8. Forecast and manage local trial budget to ensure accurate finance reporting and trial delivered on budget. Meet all finance reporting deliverables and timelines.
9. May schedule and conduct a local investigator meeting.
10. May be assigned trial sites to manage. Perform site management duties described in the Site Manager job description.
11. May identify and assess local vendors, support managers to develop and negotiate vendor contracts. Oversee provision of agreed deliverables by selected vendors in accordance with the contract, protocol and applicable SOPs.
12. Review and approve trial visit reports and oversee the prompt and appropriate communication and follow-up of findings and issues. Support the site manager with the follow-up of issues pertaining to safety, product complaints and clinical supply management. Ensure that trial management systems are appropriately maintained e.g. CTMS, eTMF.
13. Comply with relevant training requirements. Act as local expert in assigned protocols. Develops strong therapeutic knowledge to support roles and responsibilities. May represent Global Clinical Operations on cross functional teams.
14. Act as primary local country contact for a trial. Establish and maintain excellent working relationships with external stakeholders, in particular investigators, trial coordinators and other site staff; and internal stakeholders, including Medical Affairs and Marketing for Medical Affairs Trials.
15. May be required to source drug supplies from the Clinical Supplies Unit or from commercial supplies, as appropriate.
16. Lead assigned process improvement initiatives.
17. Train and mentor company staff as required.
Qualifications
Tertiary qualification; life science, medical, paramedical, pharmaceutical related degree
At least 3-4 yrs pharma company or CRO clinical research experiences;
Solid site management experience, preference will be given to those with project management experiences
Demonstrated strong understanding of company’s systems and processes
Demonstrated proficiency in the monitoring and management of clinical trials (preferably with LTM experience)
Preferably Hands-on experiences of related Therapeutic areas
At least 2-3 years in SM position in the industry
Both R&D and MAF trial experiences is preferred
Proven track records of good performance
Team orientated personality with high degree of flexibility
Strong English skills, both oral and written
Primary Location:Asia Pacific-China-Beijing-Beijing
Organization: Xian-Janssen Pharmaceutical Ltd. (7043)
Job Function: Clinical Trial Administration
Description
1. Perform country and site feasibility and prepare country feasibility report. Define any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct appropriate follow-up of pre-trial visit report information. Recommend suitable sites for selection.
2. Lead and coordinate all local trial team activities in compliance with Company Standard Operating Procedures and applicable regulations. Conduct local trial team meetings. Lead local project planning activities to meet recruitment targets and to deliver high quality data on time and within budget. Including but not limited to: development of trial specific procedures and tools, recruitment planning, risk management, budget forecasts, resource forecasts. Maintain trial management systems up to date (e.g. CTMS, eTMF). Monitor trial progress and initiate corrective and preventative actions when the trial deviates from plan.
3. May be assigned to oversee outsourced studies.
4. Organize and ensure local HA approval and any import/export permits.
5. Review and approve regulatory document packages prior to site initiation in accordance with standard operating procedures.
6. Prepare country specific informed consent form templates. Review and approve site specific informed consent forms in accordance with standard operating procedures.
7. May lead negotiation of trial site contracts and budgets. Obtain and maintain relevant insurance.
8. Forecast and manage local trial budget to ensure accurate finance reporting and trial delivered on budget. Meet all finance reporting deliverables and timelines.
9. May schedule and conduct a local investigator meeting.
10. May be assigned trial sites to manage. Perform site management duties described in the Site Manager job description.
11. May identify and assess local vendors, support managers to develop and negotiate vendor contracts. Oversee provision of agreed deliverables by selected vendors in accordance with the contract, protocol and applicable SOPs.
12. Review and approve trial visit reports and oversee the prompt and appropriate communication and follow-up of findings and issues. Support the site manager with the follow-up of issues pertaining to safety, product complaints and clinical supply management. Ensure that trial management systems are appropriately maintained e.g. CTMS, eTMF.
13. Comply with relevant training requirements. Act as local expert in assigned protocols. Develops strong therapeutic knowledge to support roles and responsibilities. May represent Global Clinical Operations on cross functional teams.
14. Act as primary local country contact for a trial. Establish and maintain excellent working relationships with external stakeholders, in particular investigators, trial coordinators and other site staff; and internal stakeholders, including Medical Affairs and Marketing for Medical Affairs Trials.
15. May be required to source drug supplies from the Clinical Supplies Unit or from commercial supplies, as appropriate.
16. Lead assigned process improvement initiatives.
17. Train and mentor company staff as required.
Qualifications
Tertiary qualification; life science, medical, paramedical, pharmaceutical related degree
At least 3-4 yrs pharma company or CRO clinical research experiences;
Solid site management experience, preference will be given to those with project management experiences
Demonstrated strong understanding of company’s systems and processes
Demonstrated proficiency in the monitoring and management of clinical trials (preferably with LTM experience)
Preferably Hands-on experiences of related Therapeutic areas
At least 2-3 years in SM position in the industry
Both R&D and MAF trial experiences is preferred
Proven track records of good performance
Team orientated personality with high degree of flexibility
Strong English skills, both oral and written
Primary Location:Asia Pacific-China-Beijing-Beijing
Organization: Xian-Janssen Pharmaceutical Ltd. (7043)
Job Function: Clinical Trial Administration