Associate Director/Director, Clinical Affairs
Job Code: CSA0511A
Rye Brook, NY
Description:
Provide leadership and supervision to the Clinical Affairs group in
company’s NY office. Responsibilities include client interaction; defining
project requirements, deliverables, schedules and budgets; managing project
schedules and budgets; promoting SOP and policy compliance; monitor resource
needs; staff management, promoting the use of tools and metrics.
Essential Duties and Responsibilities include the following. Other
duties may be assigned. Develop and manage the project management department
including, but not limited to the following areas. :
- Manage:
- Consistency of project management and clinical monitoring regarding
project requirements, deliverables, schedules and budgets.
- Communication with clients and Client Project Managers to promote
project schedule adherence, ensure that projects are adequately staffed
with personnel and resources, and meet high quality standards.
- Development and maintenance of operations and procedure manuals,
work guidelines, department metrics and project tools.
- Coordinate training and education programs to ensure staff is
trained as needed, including but not limited to relevant therapeutic
areas, ICH guidelines, and regulatory requirements
- Assist with managing and monitoring the departmental budget. Monitor
department billable percentages.
- Work closely with clinical project managers to promote operational
efficiency, teamwork, and high morale.
- Interact with clients in a customer service role and to ensure solid
team relations.
Collaborate with staff inter and intra-departmentally on the proposal
development process.
- Assist in Operations meetings and directives to improve department
and corporate policies and procedures.
- Supervise projects involving monitoring, database management, data
management/entry, programming, statistics, report writing, and agency
presentations.
- Make presentations and represent company at professional meetings
and to prospective and existing clients.
- Manage personnel activities, and provide guidance for professional
development of staff (coordinate resource distribution across projects,
interviews, makes hiring recommendations, leads disciplinary actions,
delivers performance reviews.)
- Additional Duties and Responsibilities:
- Act as back-up for project managers.
- Qualification Requirements:
- To perform this job successfully, an individual must be able to
perform each essential duty satisfactorily.
- The requirements listed below are representative of the knowledge,
skill, and/or ability required. Reasonable accommodations may be made to
individuals with disabilities to perform the essential functions.
Education and/or Experience:
- BS/BA.
- 5 years industry experience including and at least 5 years clinical
trial experience
- Minimum 5 years project and /or team management experience.
Other Skills and Abilities:
- Must have strong leadership and management skills.
- Must have the ability to handle multiple projects simultaneously and
manage multi-functional teams
- Must have creative problem solving skills; excellent verbal /
written communication skills.
- Must have strong computer skills. Must have strong time management
and organizational skills.
- Must have excellent knowledge of at least two departmental processes
and functions within the Pharmaceutical Industry and drug development
process.
- Preferred Qualifications Advanced degree
- 5+ years project management experience within a CRO
- 5+-years management experience.
Physical Demands:
The physical demands described here are representative of those that must
be met by an employee to successfully perform the essential functions of
this job. Reasonable accommodations may be made to enable individuals with
disabilities to perform the essential functions.
Some stress may occur. Some travel may be required. No special physical
demands required.
Work Environment: The work environment characteristics described here are
representative of those an employee encounters while performing the
essential functions of this job. Reasonable accommodations may be made to
enable individuals with disabilities to perform the essential functions.
This is an in-house position. General office environment.
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