Local Trial Manager-00000TB4
Description
Janssen Global Clinical Operations, Pharmaceutical companies of Johnson & Johnson Family of Companies, is looking for a Local Trial Manager.
1. Study Planning activities:
Site identification
- Assess potential investigators and decide on the suitability of the site
- If required, conduct one or more 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
2. Study start-up activities:
Site start-up
- Develop/adapt recruitment and retention strategy for the site
- Ensure that the current versions of the trial documents that are listed on the Site Initiation Report and 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 applicable, coordinate 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 fulfil 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
- Plan and conduct investigator and site-staff training
- Conduct site initiation visits
- If applicable, execute the user acceptance testing plan
- Create site specific and monitoring tools
3. Study execution activities:
Site management
- 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
- Follow up with the trial site regarding case report forms and data correction forms
- Conduct monitoring visits according to the checklist of activities listed on the Monitoring Visit Report
- 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 is used: Ensure that the IVRS at the site has been activated and tested and that unblinding capabilities are operational for those authorized to unblind subjects
- Ensure TCF is maintained as required and maintain IF
- Ensure subject commitment per site is met
4. Study close out activities:
Site close-out
- 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
5. 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
Requirements:
- Strong analytical skills;
- Strong communication skills;
- Medical education;
- Good English both written and spoken.
Primary Location:Europe/Middle East/Africa-Ukraine-Kyyivs'ka-Kiev
Organization: J&J LLC Russia (8431)
Job Function: Clinical Research MD
Description
Janssen Global Clinical Operations, Pharmaceutical companies of Johnson & Johnson Family of Companies, is looking for a Local Trial Manager.
1. Study Planning activities:
Site identification
- Assess potential investigators and decide on the suitability of the site
- If required, conduct one or more 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
2. Study start-up activities:
Site start-up
- Develop/adapt recruitment and retention strategy for the site
- Ensure that the current versions of the trial documents that are listed on the Site Initiation Report and 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 applicable, coordinate 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 fulfil 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
- Plan and conduct investigator and site-staff training
- Conduct site initiation visits
- If applicable, execute the user acceptance testing plan
- Create site specific and monitoring tools
3. Study execution activities:
Site management
- 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
- Follow up with the trial site regarding case report forms and data correction forms
- Conduct monitoring visits according to the checklist of activities listed on the Monitoring Visit Report
- 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 is used: Ensure that the IVRS at the site has been activated and tested and that unblinding capabilities are operational for those authorized to unblind subjects
- Ensure TCF is maintained as required and maintain IF
- Ensure subject commitment per site is met
4. Study close out activities:
Site close-out
- 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
5. 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
Requirements:
- Strong analytical skills;
- Strong communication skills;
- Medical education;
- Good English both written and spoken.
Primary Location:Europe/Middle East/Africa-Ukraine-Kyyivs'ka-Kiev
Organization: J&J LLC Russia (8431)
Job Function: Clinical Research MD