fhi360 Clinical Project Manager (Proposal Design) in Durham, North Carolina
FHI 360's internal CRO, Global Research Services (GRS) helps support and conduct clinical research in low-resource settings around the world. Our team includes clinical project managers, clinical research associates, research assistants, laboratory technologists, laboratory auditors, document specialists and instructional designers.
With culturally sensitive and multilingual employees in the United States, Africa, Asia, Latin America and Europe, GRS offers the following services to government and private sponsors:
Protection of participants’ safety and rights
Site identification, evaluation and development
Site monitoring, management and training
Laboratory capacity building, auditing, and training
The Clinical Project Manager (Proposal Design) must have experience in implementing complex clinical research. In this role, the PDL will be responsible for the design of GRS response to RFP's for overall coordination and management of clinical projects/studies from start up through close out activities. Proposals include directing the technical and operational aspects of the projects, ensuring the successful completion of clinical projects/studies; working with major functional area leads to identify and evaluate fundamental issues on the project, making good business decisions and ensuring solutions are implemented.
The CPM will develop a project design that ensures all project deliverables meet the sponsor's time/quality/cost expectations. S/he effectively creates operational project plans tailored to the particular needs of each assigned study. Designs the project so that all clinical study management and project deliverables will be to the Sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with Standard Operating Procedures (SOPs), policies and practices.
Designs the plan for day-to-day operations of multiple clinical trials, including trial start-up, conduct, and closeout activities.
Develops clinical operational plans, incorporating the study and scientific plan.
Creates overall operation of the entire clinical study including project planning, budget, and resource management.
Incorporates lessons learned around trial timelines, costs, and quality metrics.
Establishes study milestones and accurate tracking and reporting systems.
Serves as primary contact for development of proposals working with functional area representatives.
Recommends innovative process ideas to impact clinical trials management.
Oversee forecasting of clinical/non-clinical supplies.
May develop and evaluate proposal team to ensure the efficient operation of the function.
Applied Knowledge & Skills:
Organized, proficient at multi-tasking with exceptional attention to detail.
Able to lead, motivate and coordinate teams.
Ability to effectively use automated systems and computerized applications such as Outlook, Excel, Word, Project, etc. *Possesses cross cultural awareness and is able to adapt appropriately.
Knowledge of the key principles of cross functional project management (Time, Quality, Cost).
Can effectively plan and deliver a dynamic and persuasive presentation, using effective graphics, or slides.
Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Effective in presenting information and responding to questions from project teams, external vendors and clients.
Prior experience and demonstrated success in working with PIs and research coordinator teams required.
Ability to establish and maintain systems and processes necessary to control and report trial status and activities.
Ability to ensure that quality, regulatory-compliant clinical projects are conducted on time and within budget.
Problem Solving & Impact:
Works on problems of diverse scope that require analysis or interpretation of identifiable factors.
Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
Decisions may affect a work unit or area within a department.
Ability to read, interpret and develop clinical protocols and all associated materials. Ability to write clinical reports, protocols, business correspondence, and procedural manuals.
Master's Degree or its International Equivalent • Health Professions and Related Clinical Sciences.
Project Management (PM) Certification preferred.
3 years of previous experience in clinical research project management, possessing the knowledge, skills, and abilities to perform this job.
Proficiency in Microsoft Office, and spreadsheets required.
Able to delegate, effectively prioritizes own and workload of project team members.
Displays effective communication skills (listening, oral, and written) and can communicate in the English language (oral, written).
Possesses sound interpersonal skills, is flexible and adapts to changing situations.
Articulate, professional and able to communicate in a clear, positive concise manner with sponsors and staff.
Must be able to read, write and speak fluent English.
Requires minimal travel (15% or less).
Can be home based.
This job description 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 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.
Please click here to continue searching FHI 360's Career Portal.FHI 360 is an equal opportunity and affirmative action employer. FHI 360 is an equal employment 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, disability, veteran status, genetic information or any other status or characteristic protected under applicable law.
FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in health, education, nutrition, environment, economic development, civil society, gender, youth, research, technology, communication and social marketing — creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 60 countries and all U.S. states and territories.
As we evolve to meet the challenges of the future, we stand committed to the principles that have guided our organization for the last 40+ years. Our work continues to be grounded in research and science, strengthened by partnerships and focused on building the capacity of individuals, communities and countries to succeed.