Associate Clinical Research Project Manager (FHI Clinical) (USA)
Summary of the Position:
Responsible for the overall coordination and management or supporting the overall coordination and management of clinical projects/studies from start up through close out activities. Helps direct the technical and operational aspects of the projects, ensuring the successful completion of clinical projects/studies. May work in coordination with the Associate Project Manager (APM)or directly with major functional area leads to identify and evaluate fundamental issues on the project, make good business decisions and ensure solutions are implemented. The APM works in collaboration across the business to provide accurate labor forecasts, review of pass-through costs and ensure timely invoicing. They effectively collaborate with the CPM to create operational project plans tailored to the needs of each project. Collaborates with centralized, remote monitoring units to ensure project progress and deliverables meet contractual requirements. 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 in coordination with the CPM. Depending on the scope and magnitude of a project, the APM may work independently or in support of a CPM.
Essential Functions:
- Assist with management of the day-to-day operations of multiple clinical trials, including trial start-up, conduct, and closeout activities
- Assist with development and implementation of clinical operational plans that incorporate the study and scientific plan
- Work with CPM to create and manage overall operation of the entire clinical study including project planning, budget, and resource management
- Establish milestones and ensure that timelines, costs, and quality metrics are met
- Serve as a point-of-contact for sponsor and/or functional area representatives in managing project execution
- Perform ongoing vendor management including issue resolution, accuracy and timeliness of vendor and site payments
- Recommends and implements innovative process ideas to improve project management
- Assist with oversight of forecasting of clinical/non-clinical supplies.
- Set and meet personal and professional goals and objectives; and
- All other duties as assigned
Knowledge, Skills and Abilities:
- Can work under the direction of the CPM and show initiative in problem solving and project planning
- Knowledge of ICH / GCP regulations
- Working knowledge of FDA Guidance Documents / EU Directives / Local Regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedure
- Can delegate to Clinical Trial Associates (CTAs) and Site Management Associates (SMAs) and prioritize assignments
- Can read, interpret and develop clinical protocols and all associated materials
- Can write clinical reports, protocols, business correspondence, and procedural manuals
- Can use automated systems and computerized applications such as Microsoft Outlook, Excel, Word and SharePoint and Smartsheet
- Can plan and deliver a dynamic and persuasive presentation, using effective graphics, or slides
- Has basic proficiency in budget development and monitoring
- Driven self-starter with the ability to begin tasks independently and complete tasks without supervision
- Organized and proficient at multi-tasking with exceptional attention to detail
- Possesses cross cultural awareness and capable of adapting appropriately
- Understands the key principles of cross functional project management (Time, Quality, Cost)
- Can 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
- Possesses sound interpersonal skills, is flexible and adapts to changing situations
- Can read, write and speak English fluently
Position Requirements:
- Education: Bachelor’s Degree or its International Equivalent (Health Professions and Related Clinical Sciences)
- Preferred Job-related Experience: 1-3 years of previous experience in clinical research, possessing the knowledge, skills, and abilities to perform this job; Full understanding of Good Clinical Practice, ICH guidelines and local regulatory authority drug research and development regulations; Proficiency in Microsoft Office suite and spreadsheets required. Proficiency in Smartsheet application preferred.
- Additional Eligibility Qualifications: Technology needed: Personal Computer, Microsoft Office (i.e. Word, Excel, PowerPoint, etc.), e-mail, telephone, printer, calculator, copier, cell phones, PDAs and other hand-held devices.
Physical Expectations:
- Typical office environment.
- Ability to sit and stand for extended periods of time; ability to lift 5-50 lbs.
Travel Requirements:
- Expected travel time is 10-25% for this position.
- This can vary based on assigned project(s).