Manages projects awarded to Premier Research. Oversees and coordinates the operational aspects of assigned project personnel on ongoing projects, and ensures that the client's and internal goals of time, cost, and quality performance are met. Acts as the primary liaison with assigned clients.
ESSENTIAL JOB FUNCTIONS:
- Act as the primary liaison between Premier Research and the client on studies. Manages the Project Team, to ensure study progress is according to client and Premier Research requirements. May work on multiple projects simultaneously.
- Maintains effective communication with client and/or Project Director as required through frequent meetings, teleconferences, written correspondence, and Study Progress Reports.
- Responsible for the quality, composition and maintenance of the study files for their project.
- Ensures completion of all tasks assigned to members of the project team, including Regulatory, DataManagement, Biostatistics, QC/QA, Clinical Monitoring, and Medical Affairs.
- Maintains working knowledge of assigned Protocols, Case Report Forms, and any other study-related documents. Develops a Project Operations Manual and monitors against project progress; ensures project activity compliance with plan. Takes corrective action where necessary. Provides knowledgeable, demonstrated leadership of all study requirements to Premier Research staff.
- Maintains and evaluates study progress by using company tracking systems, status reports, site visit scheduling, and project budget review. Ensures expected progress and performance are on target throughout the study both at the project team and investigator level.
- Develops Project Specific Procedures as necessary, with responsible functional areas.
- Tracks and adheres to project budget and milestones to ensure project profitability. Takes corrective measures where necessary to keep project in line with budget and profit expectations. Identifies scope of work changes on assigned projects.
- Co-ordinates and generates contracts with external providers/third party vendors, and investigators if applicable.
- Reviews and approves clinical project expenses and ensures all study related contractual and budgeting issues are upheld and performed. Oversees and tracks invoicing and site payment issues as required.
- Chairs regular project team meetings / teleconferences and facilitates resolution of project related conflicts. Facilitates team building and communication within Operations.
- Provides project progress reports on project activities as requested.
- May participate in site selection, and training of investigators to maximize success potential.
- Works with Clinical Manager to maintain regular communication with CRAs to review overall study progress and to resolve any therapeutic or recruitment issues.
- Oversees the regulatory document collection and submission process. Maintains liaison with QA personnel to ensure a trial is appropriately audited.
- May accompany CRAs on routine monitoring visits. Helps develops an action plan for under performing sites in conjunction with CRAs.
- May review site visit reports as per SOP requirements in order to stay current with site issues and CRA performance on studies.
- May be required to monitor sites for the projects for which they are responsible.
- Coordinates the data cleanup betweenClinical Operations, DataManagement, Biostatistics, and Medical Affairs.
- Assists in Business Development activities and may attend bid defence meetings where required.
- Assists in prospective study feasibility assessment as required.
- May undertake the functions of a Clinical Manager on projects where no Clinical Manager is assigned.
- Maintains overall awareness in the field of Clinical Research, as well as assigned therapeutic areas, by reading related literature, attending training classes, attending professional meetings, etc.
- To update CV and Training records as necessary and make available for client review where appropriate.
- Remains alert for new business opportunities, network, and provides information to business development staff or manager.
- May participate in the development, training and updating of clinical Standard Operating Procedures, Local Working Guidelines and departmental policies.
- Performs other work-related duties as assigned.
- Requires a degree in the life sciences plus at least 4 years experience in clinical research, preferably as a CRA.
- Knowledge and experience with FDA/ICH/ISO14155 regulations, drug/device development and clinical monitoring procedures are necessary.
- Requires highly effective presentation, documentation, interpersonal, decision making and leadership skills, as well as strong team-oriented approach.
- Ability to handle multiple tasks to meet deadlines in a dynamic environment is essential.
- Strong computer skills are necessary
- A willingness to travel and fluency in the English language are essential
- Cardio and wound care experience preferred
- Regionally/home based locations