FMD K&L

Project Manager

Return to Postings
Posted On:
Closing On:
Wednesday, 31st July 2019
Monday, 30th September 2019
Duration:
Travel:

Job Description:

FMD K&L is a global contract research organization 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 continuously strive to raise the standard of excellence through accuracy and efficiency to achieve the highest quality output for our Customers. K&L was established in the US in 1995, and has grown to more than 1,700 employees worldwide, with key offices and delivery centers in the US, UK, China, India, Armenia, Japan and throughout the Asia-Pacific region. Please visit our website klserv.com for our company information.

Great opportunity to join a growing CRO and work with clinical trial project teams across all phases and multiple therapeutic areas. We are seeking a talented Project Manager to work onsite at our office location. 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.
  • Performs other tasks as assigned by Sr. PM staff.

Qualifications
  • 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 Outlook.
  • MBA or PMP certification is preferred.

Please email tony.roig@klserv.com for further information or inquiries.

FMD K&L is an Equal Opportunity Employer / Committed to Diversity

Preferred Skills:

Powered by JobGrok