FMD K&L is a global contract research organization (CRO) supporting data management, biostatistics, statistical programming, clinical operations, regulatory affairs, safety, pharmacovigilance, toxicology, medical affairs, medical writing, quality, risk, and compliance services to the pharmaceutical, biotechnology, and medical device industries worldwide. We are seeking a talented Project Manager to work onsite at our office location and work with clinical trial project teams and Biometrics staff across all phases and multiple therapeutic areas.  Great opportunity to join a growing CR0. Duties include but are not limited to:

• Manages Biometrics project teams from study start-up through study closeout; departments include, Data Management, Biostatistics, Statistical Programming, and Medical Writing.


• Manages multiple projects ranging in size and complexity from single service studies to large full scope biometrics projects, global projects and/or programs, with minimal oversight from supervisor.


• Serves as the primary liaison between clients, vendors, and project teams.


• Promotes team communication and cross functional collaboration in order to promote team spirit.


• Establishes and maintains relationship between client, vendors and project team, to encourage repeat and/or new business.


• Coordinates and leads team meetings; Creates and distributes agendas and minutes.


• Generates and maintains timelines, milestones, and action items.


• Manages project financials; estimates monthly accruals and initiates timely invoice generation; Identifies change orders items.


• Oversees issues and facilitates issues resolution, and escalates, when needed.


• Identify risks, mitigation, maintenance and resolution.


• Ensures training required internally and by sponsor is completed.


• Supports contract team with contracts (SOW, WO, COs, etc.) by developing the budgets and scope of work.


• Provides performance feedback for project team and managers.


• Supports business development activities (RFPs and RFIs) and governance activities, when required.

Qualfications

• Bachelor’s degree or higher in life sciences. Three plus years of experience in Pharmaceutical/CRO industry with 3+ years’ experience in Project Management.


• Solid knowledge of Biometrics services and inter-dependencies.


• Knowledge of FDA regulations, drug development and PM processes.


• Good understanding of ICH/GCP guidelines.


• Strong communication skills, both oral and written.
  •Strong team player and interpersonal skills and customer focused.


• Proficiency in Microsoft Word, Excel, Power Point, Project and OutlookMBA or PMP certification is preferred