Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies is recruiting for a Manager, Global Clinical Operations. This position can be located in New Jersey, Pennsylvania or regionally based throughout the United States.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Manager, Global Clinical Operations (GCO) will be responsible for the direct functional management of a group of Local Trials Managers (LTMs), and Site Managers (SMs) in the Neuroscience and/or Immunology Therapeutic Areas within Global Clinical Operations (GCO).
Additional responsibilities within assigned Therapeutic Area(s) include:
- Recruitment, hiring, training and development of direct reports.
- Oversee project assignment, workload distribution and problem resolution with direct reports and, as needed, team management and other functions.
- Identify, train and provide oversight of consultants.
- Performance and development in accordance with Performance Management guidelines, including coaching, mentoring and routine feedback.
- Evaluate and project resource needs on an on-going basis. Ensure the implementation of clinical studies through efficient allocation of LTMs, SMs and Administrative Associates.
- Ensure close working relationship between other GCO US groups and internal/external business partners.
- Participate in business-related task forces to improve processes.
- Understanding GCO Standard Operating Procedures (SOPs) and fulfilling the responsibilities per those SOPs.
- Ensure adequate, timely and compliant monitoring and management of clinical studies conducted in assigned Therapeutic Areas.
- Ensure that team meets project deliverables according to timelines, within budget, and with quality.
- Ensure studies are in a constant state of inspection readiness.
- Communicate with staff on program changes, policy changes, and priority shifts on a regular basis.
- Awareness of issues affecting staff's workload and efficiency.
- Inform supervisor and fellow managers of potential problem situations and work closely on problem resolution.
- Ensure staff fulfills roles and responsibilities appropriately and in a timely manner.
- Review and approve expenses; assure expense reports are being submitted on a timely basis and are in compliance with the company's policies.
- Participate in Management Staff meetings. Conduct staff meetings.
- A minimum of a Bachelor's Degree is required.
- A minimum of 8 years of Clinical Research experience within the Pharmaceutical, Clinical Research Organization (CRO) and/or Biotech industries is required.
- Knowledge of Neuroscience and/or Immunology Therapeutic Areas preferred.
- Experience with the direct management of employees is preferred.
- Experience managing and executing clinical trials preferred.
- Demonstrated experience coaching and mentoring clinical operations team members is preferred.
- Knowledge of FDA regulations as it pertains to Good Clinical Practices (GCPs) preferred.
- Proficiency with Microsoft Office (Word, Excel, PowerPoint, Outlook) is required.
- Must have excellent oral and written communication skills, along with strong presentation skills, and the innate flexibility to work in a rapidly growing organization.
- The ability to collaborate with all levels of management in a matrix environment is required.
- This position will require up to 25 % domestic travel, primarily for meetings and accompanied site visits.
United States-New Jersey-RaritanOther Locations
North America-United States-Pennsylvania-Spring House, North America-United States-New Jersey-Titusville, North America-United StatesOrganization
Janssen Research & Development, LLC. (6084)Job Function
Clinical Trial Administration