Summary of the Position:
The Clinical Project Manager (PM) serves an important role within the company and is a person who leads the delivery of our studies. The PM serves as the primary liaison between FHI Clinicalโs study teams and the customer and serves as that accountable point for delivery and quality of projects, whilst maintaining financial control. As a project leader you will manage cross functional teams across our global organization from study start-up through close-out activities. The PM is responsible for the management of complex, multi-center, multinational clinical studies, including FDA-regulated clinical trials, and ensures that all clinical study management and project deliverables are completed to the sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with Standard Operating Procedures (SOPs), policies and practices.
Essential Functions:
Serves as the primary project contact with the client.
Leads and manages cross-functional project teams, including monitoring team performance against contract and client expectations and according to key performance metrics. Provides leadership and vision to all project staff and external vendors contracted to complete projects.
Manages allocated studies according to timelines and quality standards.
Coordinates activities across all functional departments and vendors involved in the project; in some cases, the multi-functional project management lead will have to take direct responsibility for the clinical subspecialty functional area.
Develops and/or reviews study management plans.
Leads problem solving including management of risk and issue resolution.
Ensures compliance with study tools, training materials and standard processes, policies, and procedures.
Ensures strong client relationship management through clear communications, decisive escalation of issues and coordination with project team leaders and leadership appropriately.
Knowledge, Skills and Abilities:
Organized, proficient at multi-tasking with exceptional attention to detail.
Ability to lead, motivate and coordinate teams, effectively delegate tasks, and is comfortable collaborating and communicating with a variety of colleagues and clients.
Ability to effectively use automated systems and computerized applications such as Outlook, Excel, Word, Smartsheets, etc.
Possesses cross cultural awareness and can adapt appropriately. Knowledge of the key principles of cross functional project management (Time, Quality, Cost).
Ability to establish and maintain systems and processes necessary to control and report trial status and activities.
Full understanding of ICH GCP and applicable clinical trial related CFRs.
Ability to ensure that quality, regulatory-compliant clinical projects are conducted on time and within budget.
Position Requirements:
Education: Bachelor's degree in health/life sciences or related field.
Preferred Job-Related Experience: At least four (4) years of clinical research experience, preferably global project management experience within a CRO or pharmaceutical environment, and experience in clinical operations; or equivalent combination of education, training and experience.
Physical Expectations:
Able to work in non-traditional work environments.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Able to use and learn standard office equipment and technology with proficiency.
Ability to sit or stand for extended periods of time; ability to move 5-15 lbs.
Travel Requirements:
Expected travel time is 10-25% for this position. This can vary based on assigned project(s).
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned with or without notice.
FHI Clinical, Inc. provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.
This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.
FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.
Our values and commitments to safeguarding: FHI 360 is committed to preventing any type of abuse, exploitation and harassment in our work environments and programs, including sexual abuse, exploitation and harassment. FHI 360 takes steps to safeguard the welfare of everyone who engages with our organization and programs and requires that all personnel, including staff members and volunteers, share this commitment and sign our code of conduct. All offers of employment will be subject to appropriate screening checks, including reference, criminal record and terrorism finance checks. FHI 360 also participates in the Inter-Agency Misconduct Disclosure Scheme (MDS), facilitated by the Steering Committee for Humanitarian Response. In line with the MDS, we will request information from job applicantsโ previous employers about any substantiated findings of sexual abuse, exploitation and/or harassment during the applicantโs tenure with previous employers. By applying, job applicants confirm their understanding of these recruitment procedures and consent to these screening checks.
FHI 360 will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws.
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