Johnson & Johnson BS Life Sciences CRA Job Opening, Apply Online

Johnson & Johnson BS Life Sciences CRA Job Opening, Apply Online

Johnson & Johnson BS Life Sciences CRA Job Opening, Apply Online. BS Life Sciences vacancies. Johnson & Johnson Hiring. Interested and eligible applicants can check out all of the details on the same below

Possible Interview Questions are posted below

Sr. Site Manager – CRA – Hyderabad/Bangalore/Chennai-2306113182W
Description

Position Summary:

A Sr. Site Manager serves as the primary contact point between the Sponsor and the Investigational Site. A Sr. Site Manager is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. Responsibilities may include assisting with site selection, pre-trial assessment, subject recruitment and retention planning, site initiation, on-site and remote monitoring and close-out activities. Site Manager will partner with the Local Trial Manager (LTM), Clinical Trial Assistant (CTA) and Clinical Trial Manager (CTM) to ensure overall site management while performing trial related activities for assigned protocols. A Site Manager II may contribute to process improvement, training and mentoring of other Site Managers.

Principal Responsibilities:

1. Acts as primary local company contact for assigned sites for specific trials.
2. May participate in site feasibility and/or pre-trial site assessment visits
3. Attends/participates in investigator meetings as needed.
4. Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of analytical risk based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
5. Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases. Responsible in close collaboration with LTM and central study team for the activities during site activation phase in order to speed up the process and activate the site in shortest possible timeframe.
6. Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.
7. Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.
8. Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
9. Arranges for the appropriate destruction of clinical supplies.
10. Ensures site staff complete data entry and resolve queries within expected timelines.
11. Ensures accuracy, validity and completeness of data collected at trial sites
12. Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs )/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
13. Maintains complete, accurate and timely data and essential documents in relevant systems utilized for trial management.
14. Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
15. Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
16. Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team.
17. Attends regularly scheduled team meetings and trainings.
18. Complies with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.
19. Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g. On Site Quality Monitoring Visit (OSQMV).
20. Prepares trial sites for close out, conduct final close out visit.
21. Tracks costs at site level and ensure payments are made, if applicable.
22. Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
23. May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.
24. Acts as a point of contact in site management practices.
25. May be assigned as a coach and mentor to a less experienced site manager.
26. May contribute to process improvement and training.
27. Leads and/or participates in special initiatives as assigned.
28. May assume additional responsibilities or special initiatives such as “Champion” or Subject Matter Expert”.

This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.

Principal Relationships:

• Primary Reporting Structure: Reports to a functional manager
• Primary interfaces: Functional Manager, CTA, LTM and CTM.
• Other Internal Interfaces: R&D Country Head, Therapeutic Area Manager/Physician, Quality & Compliance Manager/Specialist, Training Manager, Contracts & Grants, Local Drug Safety Officer (where required) and Site Manager team.
• External Interfaces: Investigators and their delegates at site (trial site personnel).

Qualifications

1. A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
2. A minimum of 4-6 years of clinical trial monitoring experience is preferred, however, other relevant experiences and skills may be considered by the hiring manager when considering the candidate’s eligibility.
3. Specific therapeutic area experience may be required depending on the position.
4. Strong working knowledge of GCP, company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
5. Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
6. Proficient in speaking and writing the country language and English. Good written and oral communication.

Primary Location: Asia Pacific-India-Andhra Pradesh-Hyderabad

Other Locations: Asia Pacific-India-Tamil Nadu-Chennai, Asia Pacific-India-Karnataka-Bangalore, Asia Pacific-India-Maharashtra-Greater Mumbai

Organization: Johnson & Johnson Private Limited (8080)

Job Function: Clinical Trial Administration

APPLY ONLINE

Possible Interview Questions:

1. Can you explain your experience and role as a Sr. Site Manager in ensuring inspection readiness and compliance with clinical trial protocols, SOPs, GCP, and applicable regulations? How have you handled challenges related to protocol adherence and regulatory compliance? Answer: In my role as a Sr. Site Manager, I have been responsible for ensuring inspection readiness and compliance with clinical trial protocols, SOPs, GCP, and regulations. This involves working closely with the investigational site, conducting site assessments, and monitoring trial activities. To address challenges, I have implemented robust processes for protocol adherence, including training site staff on the specific requirements, conducting regular site monitoring visits, and promptly addressing any non-compliance issues through corrective and preventive actions.
2. How do you ensure effective site management and coordination between different stakeholders, such as the Local Trial Manager, Clinical Trial Assistant, and Clinical Trial Manager? Can you provide an example of a situation where you successfully collaborated with these stakeholders to overcome a trial-related challenge? Answer: As a Sr. Site Manager, effective coordination with various stakeholders is crucial for successful trial management. I ensure regular communication and collaboration with the Local Trial Manager, Clinical Trial Assistant, and Clinical Trial Manager to align on trial objectives, address site-specific challenges, and ensure smooth execution. For example, I encountered a situation where subject recruitment was falling behind schedule. I worked closely with the Local Trial Manager and implemented a targeted recruitment strategy, which included revising recruitment materials, collaborating with investigators, and leveraging local networks. This collaborative approach resulted in an improved recruitment rate and timely completion of the trial.
3. How do you ensure accurate and timely data collection at trial sites? Can you describe your experience in resolving data queries and maintaining data integrity throughout the trial? Answer: Data collection and integrity are critical aspects of clinical trials. As a Sr. Site Manager, I ensure that site staff are trained on data collection procedures and maintain complete and accurate records. I actively monitor data entry and resolve queries promptly to ensure data validity and completeness. In my previous role, I implemented a robust system for query resolution, which involved close collaboration with site staff and the data management team. This approach ensured that data queries were resolved within expected timelines, contributing to high-quality trial data.
4. How do you ensure compliance with adverse event reporting timelines and accurate documentation of adverse events, serious adverse events, and product quality complaints? Can you describe your experience in managing adverse event reporting and documentation processes? Answer: Adverse event reporting and accurate documentation are crucial for patient safety and regulatory compliance. As a Sr. Site Manager, I have a strong understanding of reporting timelines and guidelines for adverse events, serious adverse events, and product quality complaints. I ensure that site staff are trained on these processes and oversee their adherence to reporting timelines. I also review adverse event documentation for consistency and accuracy, ensuring alignment with source documents. Additionally, I collaborate closely with the Local Trial Manager and other stakeholders to ensure appropriate reporting and documentation of adverse events throughout the trial.
5. Can you describe your experience in mentoring and coaching less experienced site managers? How have you contributed to process improvement and training initiatives in your previous roles? Answer: As a Sr. Site Manager, I have had the opportunity to mentor and coach less experienced site managers, facilitating their professional growth and development. I have provided guidance on trial management best practices, SOP adherence, and effective stakeholder communication. Additionally, I have actively contributed to process improvement initiatives by identifying areas for enhancement, proposing solutions, and implementing changes to streamline site management activities. Furthermore, I have participated in training programs to share my expertise and knowledge with other site managers, contributing to their overall competency and success.

Note: The answers provided here are just examples. It is recommended to personalize the answers based on the candidate’s own experiences and achievements.

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