At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
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**Job Function: **
R&D Operations
**Job Sub Function: **
Clinical Trial Project Management
Job Category:
Professional
All Job Posting Locations:
Johannesburg, Gauteng, South Africa
Job Description:
**About Innovative Medicine **
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for a **Lead Local Trial Manager (Lead LTM) **who will be responsible for the local management and oversight of clinical trials (or Medical Affairs data generation activity). The head office location is in **Johannesburg, Gauteng, South Africa **, and this position is hybrid. We are hiring for several therapeutic areas; preferably the candidate will have experience in either Haematology, Oncology, Neuroscience, or Immunology.
Purpose:
The Lead LTM 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 Lead LTM is responsible for proactively 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 Lead LTM proactively leads or contributes to process improvement; training and mentoring of other LTM s and Site Managers (SM).
You will be responsible for:
- Collaborating with Clinical Research Manager (CRM) for country protocol and site feasibility assessments, in conjunction with the local study team. Implements any local criteria for site selection. Ensuring consistent conduct of pre-trial assessment visits and instruct teams on appropriate follow-up of pre-trial visit report and country feasibility report. Recommending suitable sites for selection to participate in trial.
- Collaborating with the Global and Local Project Teams to deliver for South Africa.
- Contributing input to the study management documents at a country level or initiating development of these documents for a single country trial, as per SOPs
- Leading and coordinating local trial team activities in compliance with SOPs, other procedural documents and applicable regulations. Leading local project planning activities to meet recruitment targets and delivering 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.
- Maintaining and updating trial management systems. Using study tools and management reports available to analyse trial progress
- Monitoring country progress and initiating corrective and preventive actions (CAPA) when the trial deviates from plans and communicating study progress and issues to study management teams.
- Conducting local trial team meetings and providing or facilitating SM training when needed (i.e. implementation of study amendment-and changes in study related processes).
- Reviewing and approving Monitoring Visit Reports submitted by SM; identifying issues and/or trends across a trial project and escalating deviation issues to the CTM/GTL and FM as needed.
Qualifications/Requirements:
- A minimum of a BA or BS degree in Life Sciences, Nursing or related scientific field (or equivalent experience) is required!
- Minimum of 7 years of ZA clinical trial experience is preferred, including site monitoring experience and local submission experience
- Should have solid understanding of the drug development process including GCP and local regulatory requirements.
- Strong leadership and communication skills.
- Project management experience strongly preferred.
- Therapeutic area experience in Haematology, Oncology, Neurology or Immunology preferred.
- Proficient in speaking and writing the English language.
- Excellent written and oral communication skills Strong experience in mentoring/coaching and providing training to other LTMs, SMs and CTAs.
- Demonstrated ability to lead initiative/small teams.
- Ability to work on multiple trials in parallel in different disease areas, if required.
- Ability to commute to J&J Johannesburg, Gauteng, South Africa 3x weekly
Leadership Behaviors Required:
- LIVE OUR CREDO: Puts the needs of Our Credo stakeholders first, pursues the highest standards of quality, safety, compliance & ethics and ensures everyday actions contribute to Our Purpose.
- CONNECT: Builds internal and external relationships based on respect, collaborates openly across boundaries and acts as a team player.
- SHAPE: Inspires and contributes ideas that challenge thinking, demonstrates resilience and agility to drive and adapt to change.
- GROW: Develops self and others to reach their goals, engages in open & honest conversations and drives performance by managing energy and taking ownership for outcomes.
**Required Skills: **
Clinical Site Monitoring, Clinical Trial Management, Submission Management
Preferred Skills:
Business Behavior, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Give Feedback, Laboratory Operations, Medical Knowledge, Mentorship, Problem Solving, Process Oriented, Professional Ethics, Project Integration Management, Project Management, Research and Development, Research Ethics