Johnson & Johnson BSc Life Sciences Job Opening, Apply Online
Johnson & Johnson BSc Life Sciences Job Opening, Apply Online. Johnson & Johnson Clinical Trial Administration For BSc Life Sciences. Apply for Sr. Site Manager job at Johnson & Johnson. Interested and eligible applicants can check out all of the details on the same below
Possible Interview Questions are posted below
Sr. Site Manager – Mumbai/Bangalore/Hyderabad-2306130659W
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
Description
Global Clinical Operations (GCO)
Position Title*: Sr. Site Manager (*Title may vary based on Region or Country requirements)
Position Summary:
A Site Manager serves as the primary contact point between the Sponsor and the Investigational Site. A 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:
- Acts as primary local company contact for assigned sites for specific trials.
- May participate in site feasibility and/or pre-trial site assessment visits
- Attends/participates in investigator meetings as needed.
- 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.
- 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.
- Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.
- Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.
- Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
- Arranges for the appropriate destruction of clinical supplies.
- Ensures site staff complete data entry and resolve queries within expected timelines.
- Ensures accuracy, validity and completeness of data collected at trial sites
- 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.
- Maintains complete, accurate and timely data and essential documents in relevant systems utilized for trial management.
- 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.
- Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
- Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team.
- Attends regularly scheduled team meetings and trainings.
- Complies with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.
- 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).
- Prepares trial sites for close out, conduct final close out visit.
- Tracks costs at site level and ensure payments are made, if applicable.
- Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
- May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.
- Acts as a point of contact in site management practices.
- May be assigned as a coach and mentor to a less experienced site manager.
- May contribute to process improvement and training.
- Leads and/or participates in special initiatives as assigned.
- May assume additional responsibilities or special initiatives such as “Champion” or Subject Matter Expert”.
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).
- A minimum of a BA or BS degree in Life Sciences, Nursing or a related scientific field (or equivalent experience) is required.
- A minimum of 2-6 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.
- Specific therapeutic area experience may be required depending on the position.
- Strong working knowledge of GCP, company SOPs, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
- Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
- Proficient in speaking and writing the country language and English. Good written and oral communication.
Possible Interview Questions:
- Can you describe your experience in clinical trial monitoring? How many years have you been involved in this role, and what specific responsibilities have you handled? Answer: I have been working as a clinical trial monitor for X years. In this role, I have been responsible for ensuring inspection readiness, compliance with protocols and regulations, site initiation, monitoring activities, and close-out procedures.
- How familiar are you with Good Clinical Practice (GCP) guidelines, company Standard Operating Procedures (SOPs), and local laws and regulations related to clinical trials? Answer: I have a strong working knowledge of GCP guidelines, company SOPs, and local laws and regulations. I have been consistently adhering to these guidelines in my previous roles to ensure compliance and the highest ethical standards in clinical trial operations.
- Can you provide an example of a challenging situation you faced during a clinical trial and how you resolved it? Answer: During a previous clinical trial, we faced recruitment challenges due to a specific demographic requirement. To overcome this, I collaborated closely with the study team and developed a targeted recruitment strategy, which involved expanding our network of investigators and utilizing innovative outreach methods. This approach resulted in successful subject recruitment and retention, meeting the trial’s objectives.
- How do you ensure the accuracy and completeness of data collected at trial sites? Can you provide an example of how you have addressed data quality issues in the past? Answer: To ensure data accuracy and completeness, I have implemented thorough data entry and query resolution processes. I regularly communicate with site staff to address any queries promptly, and I perform regular data quality checks to identify and resolve discrepancies. In a previous trial, I noticed discrepancies in data collection, and I conducted additional training sessions for site staff to improve their understanding of data collection protocols, resulting in improved data quality.
- How do you maintain effective communication and collaboration with investigators, trial coordinators, and other site staff? Can you provide an example of a successful collaboration you have had in the past? Answer: I prioritize building strong working relationships with site personnel through regular communication and mutual respect. In a previous trial, I collaborated closely with the investigators and trial coordinators to ensure seamless coordination of trial activities. We established open lines of communication, organized regular meetings, and addressed any concerns promptly. This collaboration resulted in efficient trial conduct, meeting timelines, and maintaining a positive working environment.
Note: The answers provided are sample responses and can be tailored based on the individual’s specific experiences and qualifications.
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