Summary of the Position:

The FHI Clinical Associate Clinical Project Manager (APM) – US is responsible for and provides project-related support to the Senior Clinical Project Manager/ Clinical Project Manager(s) and other project team members from project start-up through final deliverables. The APM will work in tandem with the project manager to perform project management duties to support the completion of projects. Project Management Associates participate during all phases of the project management process. The APM responsibilities may include scheduling and conducting project meetings, communicating assignments and expectations to project team members, drafting plans, and tracking completion of project deliverables to ensure quality and integrity of all project-related products.

Essential Functions:

• Assist with management of the day-to-day operations of multiple clinical trials, including trial start-up, conduct, and closeout activities.
• Understand a project’s scope and create documents for project requirements.
• Conduct project meetings, as assigned, to communicate individual roles, project expectations, and ensure that all project team members have the tools and training required to perform effectively
• Assist with development and implementation of study and clinical operational plans
• Work with Senior Project Manager and/or Project Manager to create and manage operations of the clinical study including project planning, timeline development, risk/issue management, budget management, and resource management.
• Work with Senior Project Manager and/or Project Manager to establish milestones and ensure that timelines, costs, and quality metrics are met.
• Perform ongoing vendor management, as needed, including issue escalation as needed and timely resolution, accuracy and timeliness of vendor and site payments.
• Recommends and implements innovative process ideas to improve processes and/or tools.

Knowledge, Skills, and Abilities:

• Can work under the direction of the Senior Project Manager and/or Project Manager and show initiative in problem solving and project planning, along with the ability to prioritize tasks and assignments
• Organized, proficient at multi-tasking with exceptional attention to detail
• Ability to lead, motivate and coordinate teams, 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.
• 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, or international equivalent, preferably in life sciences or related field
• Preferred Job-related Experience: Minimum of two (2) years of project management or related work experience. Experience in clinical research is preferred. Requires intermediate-level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with 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 and stand for extended periods of time; ability to lift or push 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 applicants’ previous employers about any substantiated findings of sexual abuse, exploitation and/or harassment during the applicant’s 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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FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.

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