Director, Project Management
Posted on: September 6, 2019
Overview Summary of Responsibilities
The Director, Project Management (PM), is responsible for the
strategic and tactical operations of the PM department and serves
as department head. The Director effectively manages all aspects of
project management, including hiring, training, coaching PM staff
as well as meeting all time frames and targets to both internal and
external (Sponsors ) satisfaction. The role directs the scope of
work, objectives, quality of deliverables, and other clinical
activities of all CRO projects, which may be multi-regional in
scope. He/She ensures appropriate communication channels are
maintained and reporting schedules are adhered to by Project
Managers. The Dir., PM ensures the development of project plans and
key performance indices for all phases of the project lifecycle.
Collaborates with Business Development to finalize project budgets
and scope of work and oversees management of project budget(s) to
meet departmental and corporate financial goals, proactively
Responsibilities Essential Functions
- Understand the Advanced Clinical overall financial plan and
contribution to support Advanced Clinical s overall financial
- Maximize productivity to exceed AC budget goals.
- Identify possible improvements to current processes, determine
new processes that are needed, and initiate a plan to improve or
develop said processes.
- Train, mentor, monitor, and supervise Project Managers and
other appropriate clinical personnel as necessary.
- Coordinate PM assignments across projects to ensure all targets
and deadlines are met
- Conduct annual and semi-annual evaluations for direct
- Write training and establish training programs for PMs on new
- Participate in recruitment and selection of PMs
- Standard Operating Procedures (SOPs)
- Be familiar with and follow department SOPs.
- Ensure staff is adequately trained on and following SOPs.
- Create and review SOPs to recognize and prevent potential
regulatory issues Business Development
- Assist with RFP/RFI completion
- Attend sales meetings as requested by Business Development
- As needed, participate in or take responsibility for clinical
tasks including: updating, compiling, and reporting various
clinical tracking information; managing clinical studies; and any
other tasks within the scope of project management.
- As appropriate, will participate in the study development and
start-up process including reviewing protocols, preparing Informed
Consent Forms, developing study documents, organizing and
presenting at investigator meetings, working with management on
program strategy, and/or developing project-specific PM
- Participate in clinical training programs and developmental
programs in the field of clinical research, as needed.
- Direct the allocation of resources to clinical projects by
assigning staff to clinical studies that are appropriate to their
experience and training.
- Ensure staff are meeting defined workload and quality metrics
through regular review and reporting of findings as outlined by
clinical operations management.
- May participate in project management quality or process
- Perform other duties as requested by management
- Work with Business Development in pursuit of their goals
- Participate with Marketing toward corporate objectives
Bachelor's degree in a health-care or scientific discipline with 10
yrs of industry experience working on clinical trials and 6 years
of experience in a senior leadership capacity; or equivalent
combination of education, training and experience.
The list below includes the general training subjects, and not
necessarily the exact name of the training course obtained:
- Applicable Standard Operating Procedures
- 21 CFR all applicable parts
- FDA Guidance Documents including ICH E6
- Drug Development and Approval Process
- Medical Device Development and Approval Process Certification:
None required, PM Certification or Healthcare licensures or
The ideal candidate should have:
- Exceptional leadership skills and proven industry vision.
- Efficient and effective time management skills with ability to
successfully manage competing priorities.
- The ability to establish and maintain effective working
relationships with executive management, coworkers, managers and
- Excellent organizational and problem solving skills.
- Advanced knowledge of, and ability to apply GCP/ICH and all
applicable regulations and guidelines.
- Superior written and verbal communication skills including
excellent command of English with computer skills including
proficiency in use of Microsoft Word, Excel and
PowerPoint.Associated topics: administrative, administrative
assistant, administrative coordinator, administrative officer,
administrative staff, document, front desk, operations director,
records management, support
Keywords: AdvancedRPO, Schenectady , Director, Project Management, Executive , Schenectady, New York
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