Clinical Project Manager

Prevail InfoWorks focuses on eClinical technology products including Clinical Data Integration, Clinical/Operational Risk-Based Data Analytics and Dashboards, eDC, eTMF, Safety System, IxRS/RTSM, CTMS, Investigator Grant Management and Clinical Budget Management. We provide these products in a SaaS model with world-class delivery, support and related clinical operations services. The Philadelphia based company has a 15+ year track record of exceeding expectations and earning repeat business with its global biotech, biopharma, device and diagnostics customer base. We are expanding our Clinical Project Management team with people who have drive, creativity, self-motivation, and professionalism. We are seeking a Clinical Project Manager with a minimum of 3 years of experience. Essential Duties and Responsibilities The Clinical Project Manager (PM) is responsible for independently managing multiple clinical trials and overseeing the project team. The PM is expected to be the primary liaison between Prevail and the sponsor, address site and vendor related issues, and ensure timely delivery of milestones. They are also responsible for end to end project life cycle management including study start-up, conduct, and close-out. Essential Functions: Manages the scope of work, objectives, timelines, quality of deliverables, and all other project management activities for assigned project(s).Accountable for coordinating deliverables across all functional areas to drive overall study timeline. Develops and maintains comprehensive project plans covering all phases of the project and associated deliverables. Manages third-party vendors such as partner CROs, diagnostic labs, SME consultants,, meeting planners, drug depots, etc. Contributes to the development and management of budgets/scope of work, timelines and quality guidelines for projects, thereby ensuring that expectations are met while identifying and mitigating risks. Oversees the maintenance of project management information and internal data tracking systems. Identifies, evaluates, and manages project risks; develops and implements quality and risk management plans to minimize impact on project objectives. Continually assesses resource capacity and ensures adequate internal resources are available to meet project deliverables and milestones. Develops and implements continuous improvement initiatives for assigned projects to enhance the efficiency and quality of work. Contributes to internal planning activities, including providing input on scope, timelines, and budget assumptions for initiatives and proposals. Executes proactive trial management to identify challenges, develops effective mitigation plans and appropriately escalates to and informs all relevant parties. Ensures management of trials are completed in compliance with ICH, GCP, global standards, local laws and regulations. Supports client communications with status reporting, agenda, minutes and changes orders. Maintains professionalism with external and internal stakeholders at all times, setting an example of leadership for project team members. The above statements are intended to describe the work being performed by people assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of the personnel so classified. This is an equal employment opportunity, and Prevail does not discriminate in employment on the basis of race, color, religion, sex, sexual orientation, national origin, age, disability or veteran/Reserve/National Guard status. Supervisory Responsibilities Direct supervision of all support staff assigned on a project basis. This includes cross-functional services such as supplies and logistics, data management, Pharmacovigilance, TMF managers, and software engineers and designers. Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Education and/or Experience Minimum of a bachelor’s degree with a major in science, nursing, or other health related field is required.. Minimum of 3 years progressive clinical project management experience is required. Experience serving as a site study coordinator, or within a clinical operations role at a CRO or sponsor company is desired. Must have customer service orientation and be a proactive and effective communicator. Excellent interpersonal and teamwork skills are imperative. General knowledge of all applicable regulations (GCP, FDA, OHRP, HIPAA). Demonstrated proficiency with all Microsoft Office Tools. Language Skills Possess the ability to communicate and comprehend written and oral instructions. Able to effectively present information and respond to questions from colleagues and customers. Reasoning Ability Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Able to apply common sense solutions towards the execution of responsibilities. Physical Demands The incumbent must occasionally lift and/or move up to 50 pounds. Incumbent must have the ability to spend extended periods of time sitting and traveling via car, plane and/or train. Work Environment This job is performed in an office setting or remotely. Other As provided by the Americans with Disabilities Act, the company is committed to discussing and providing reasonable accommodations to its employees to help them fulfill the essential functions of their jobs.