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 Clinical Research Project Manager 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 Associate CRPM works in collaboration across the business to provide accurate labor forecasts, review of pass-through costs and ensure timely invoicing. S/he effectively collaborates with the Project Manager 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 CRPM.
Depending on the scope and magnitude of a project, the Associate CRPM may work independently or in support of a Clinical Research Project Manager to:
- Manage the day-to-day operations of multiple clinical trials, including trial start-up, conduct, and closeout activities;
- Develop and implement clinical operational plans that incorporate the study and scientific plan;
- 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; and
- Oversees forecasting of clinical/non-clinical supplies.
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
Supervision Given / Received:
- Provides suggestions on business and operational decisions that affect the department. *May serve as team lead to team members. *Typically reports to a Manager
- Must work cohesively and in collaboration with lead project oversight and embody directive of the Clinical Research Project Manager and execute deliverables under their guidance
- Can work under the direction of the Clinical Research Project Manager and show initiative in problem solving and project planning;
- Can delegate to Clinical Trial Associates 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 Outlook, Excel, Word, Project, SharePoint;
- Can plan and deliver a dynamic and persuasive presentation, using effective graphics, or slides;
- Has basic proficiency in budget development and monitoring;
- Organized, 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;
- 1-3 years of previous experience in clinical research, possessing the knowledge, skills, and abilities to perform this job
- Proficiency in Microsoft Office, and spreadsheets required
- Possesses sound interpersonal skills, is flexible and adapts to changing situations; and
- Can read, write and speak English fluently.
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