Janssen Research & Development LLC., a member of Johnson
& Johnson's Family of Companies, is recruiting for a Functional Manager, Global
Clinical Operations - Oncology, to 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.
Thriving on a diverse company culture, celebrating the
uniqueness of our employees and committed to inclusion. Proud to be an equal
The Functional 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
Oncology Therapeutic Area within Trial Coordination Site Management,
Global Clinical Operations. This
individual will also be responsible for the recruitment, hiring, training and
development of direct reports; will 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.
Additional responsibilities within assigned Therapeutic
- Performance and development in accordance with
Performance Management guidelines, including coaching, mentoring and routine
- Evaluate and project resource needs on an on-going
- Ensure the implementation of clinical studies through
efficient allocation of LTMs, SMs and Administrative Associates.
- Ensure close working relationship between other Trial
Coordination and Site Management U.S. groups and internal/external business
- Participate in business-related task forces to improve
- Have knowledge of 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 their Therapeutic Area.
- Communicate with staff on program changes, policy
changes, and priority shifts on a regular basis.
- Be aware 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
- A minimum of a Bachelor's Degree or Advanced
Degree is required.
- A minimum of 6 or more years of Clinical
Research experience from the Pharmaceutical, Clinical Research Organization
(CRO) and/or Biotech industries is required.
- Experience in Oncology is required.
- Experience with the direct management of
employees is required.
- Experience working in a matrix environment is preferred.
- Experience managing and executing clinical
trials is required.
- Demonstrated experience coaching and mentoring
clinical operations team members is preferred.
- Knowledge of FDA regulations as it pertains to Good
Clinical Practices (GCPs) is 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.
- This position requires up to 25% annual travel
United States-New Jersey-RaritanOther Locations
North America-United States-Pennsylvania, North America-United StatesOrganization
Janssen Research & Development, LLC. (6084)Job Function
Clinical Trial Administration