Johnson & Johnson Family of Companies Vacancies | Local Trial Manager Career Opportunity at Johnson & Johnson Family of Companies Careers Web-page. Johnson & Johnson Family of Companies Johannesburg, Gauteng Jobs . Find-out Johannesburg, Gauteng Government Jobs for freshers. Johannesburg Entry Level Jobs In Gauteng. Get latest job Opportunity in South African Government. South African Government Jobs in Johannesburg, Gauteng. Get All Hiring Updates From www.jnjconsumer.co.za
Notification Out From Johnson & Johnson Family of Companies Careers Portal, Candidates Those Are Searching For Career Opportunities In Johnson & Johnson Family of Companies, Can Apply For Jobs In Johnson & Johnson Family of Companies For The Position Of Local Trial Manager. Read Out Full Job Description About This Johnson & Johnson Family of Companies Recruitment Described Below. But Before You First Confirm That Your Profile Matches With Recruiters Defined Eligibility Criteria.
Johnson & Johnson Family of Companies Vacancies | Local Trial Manager Careers Opportunity In Johannesburg, Gauteng
Johnson & Johnson Family of Companies Opened Hiring On Their Official Careers Portal, Job Seekers Who Are Eligible And Interested To Work With Johnson & Johnson Family of Companies As A Local Trial Manager, Now They Can Apply For Johnson & Johnson Family of Companies Vacancies. This Is Great Career Opportunity For Those Candidates Who Are Looking For A Employment Opportunity On Johnson & Johnson Family of Companies Careers Portal. Candidates Need Experience From Relevant Field And Required Qualification. Selected Candidates Will Get A Pay Of Around R 14731.00 per month. Johnson & Johnson Family of Companies Vacancies In Johannesburg, Gauteng.
Briefed Details Of Johnson & Johnson Family of Companies Vacancies For Position Of Local Trial Manager
Recruiting Agency / Department :- Johnson & Johnson Family of Companies
Vacant Position :-Local Trial Manager
Jobs Type :- Johnson & Johnson Family of Companies Vacancies South Africa
Salary :- R 14731.00 per month
Apply Through:- www.jnjconsumer.co.za
Johnson & Johnson Family of Companies Vacancies In Gauteng, South Africa Full Job Description
LOCAL TRIAL MANAGER
The Local Trial Manager II (LTM II) is responsible for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries. The LTM II is the primary point of contact at a country level for assigned studies and has operational oversight of assigned protocol(s) from start-up through to database lock and closeout activities as described in GCO procedural documents. The LTM II is responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and regulatory requirements.
The LTM II actively contributes to process improvement; training and mentoring of Clinical Trial Assistants (CTA), Site Managers (SM) and LTM I roles. The LTM II may have some site management responsibilities.
The LTM II may also perform the role of Clinical Trial Manager (CTM)/Global Trial Lead (GTL) for single country as described in GCO procedural documents.
The responsibilities & the impact YOU will have:
The main duties and responsibilities of the position are:
- Collaborate with Functional Manager (FM)/Clinical Research Manager (CRM) for country protocol
feasibility (if applicable) and site feasibility assessment in conjunction with CTA (if applicable), SM and CTM/GTL. Implements any local criteria for site selection. Ensure consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommends suitable sites for selection to participate in trial.
- Collaborates with the Global Product Lead (GPL), CTM/GTL, local management/Country Head and other study team member to select final site list.
- Contributes input to the study management documents at a country level or initiates development of these documents for a single country trial, as per SOPs
- Leads and coordinates local trial team activities in compliance with SOPs, other procedural documents, and applicable regulations. Leads local project planning activities to meet recruitment targets and to deliver high quality data on time and within study budget. Including but not limited to: development of local trial specific procedures and tools, recruitment planning, contingency and risk management, and budget forecasting.
- 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.
- Maintains and updates trial management systems. Uses study tools and management reports available to analyse trial progress
- Monitors country progress and initiates corrective and preventive actions (CAPA) when the trial deviates from plans and communicates study progress and issues to study management teams.
- May submit requests for vendor services and may support vendor selection.
- In certain situations, may assist in negotiation of trial site contracts and budgets. Forecasts and manages country/local trial budget to ensure accurate finance reporting and trial delivered –within budget. Adheres to finance reporting deliverables and timelines.
- Attends/participates in Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting
- Conducts local trial team meetings and provides or facilitates SM training when needed (i.e. Implementation of study amendment-and changes in study related processes).
- Reviews and approves Monitoring Visit Reports submitted by SM; identifies issues and/or trends across a trial project and escalates deviation issues to the CTM/GTL and FM as needed
- Reviews and approves site and local vendor invoices as required. Manages local study supply, as required.
- Prepares country specific informed consent in accordance with procedural document/templates. Reviews and manages site specific informed consent forms in accordance with SOPs, other procedural documents and applicable regulations.
- Organizes and ensures IEC/HA approvals, if applicable, and ensure that the trial is in compliance with local regulatory requirements
- Works with SM to ensure CAPA is implemented for audits and inspection or any quality related visits
- Complies with relevant training requirements.
- Acts as subject matter expert for assigned protocols. Develops strong therapeutic knowledge to support roles and responsibilities. May represent GCO on cross functional teams.
- Acts as primary local/country contact for a trial. Establishes and maintains excellent working relationships with external stakeholders, in particular investigators, study trial coordinators and other site staff; and internal stakeholders, including Medical Affairs and Marketing for Medical Affairs trials.
- Actively contributes to process improvement, training and mentoring of CTAs, SM and other LTMs.
- Conducts accompanied site visits with SM as delegated by FM.
- May assumes additional responsibilities or special initiatives such as “Champion” or “Subject Matter Expert”.
- May represents functional area in process initiatives as required
- Primary Reporting Structure: Reports to a Functional Manager
- Primary interfaces: Functional Manager/CRM, CTAs, SMs, CTM/GTLs, Study Responsible Physicians (SRP), Quality & Compliance Managers/Specialists, Local Safety Officer
- Other Internal Interfaces: R&D Country Head, Regional Therapeutic Area Experts (RTAEs), Contracts & Grants, CTM/GTL, R&D study team (e.g., SRP), data management and Medical Affairs (when applicable)
- External Interfaces: Trial Site Personnel, external vendor representatives, Ethics Committee and others as required
We’d love to hear from YOU, if you have:
- A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required.
- Minimum two to four years of pharmaceutical and/or clinical trial experience is preferred (including site monitoring experience), 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. Should have solid understanding of the drug development process including GCP and local regulatory requirements.
- Willingness to travel with occasional overnight stay away from home.
- Solid leadership skills. Solid communication and computer skills required. Proficient in speaking and writing the country language and English language. Excellent written and oral communication skills
- Some experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs preferred. The ability to lead initiative/small teams.
- Flexible mindset and ability to work in a fast-changing environment. Ability to work on multiple trials in parallel.
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences
That is why we in South Africa are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!
When appointing potential candidates in South Africa, the Employment Equity and Broad-Based Black Economic Empowerment Legislation will be considered
Janssen Pharmaceutica (Pty.) Ltd. (8490)