Clinical Project Manager / Sr Clinical Project Manager - CNS 8/23/2016

INC Research Irvine, CA

Company
INC Research
Job Classification
Full Time
Company Ref #
16004296-IrvineCA
AJE Ref #
575960105
Location
Irvine, CA
Experience
Entry Level (0 - 2 years)
Job Type
Regular

JOB DESCRIPTION

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Do you want to be a part of a growing global top 10 CRO* INC Research is a full-service contract research organization, providing the full range of Phase I to IV clinical development services for the world s pharmaceutical, biotech and medical device industries. We do this across six continents. We believe that therapeutic and operational experience forms the foundation for taking medicines successfully through clinical development. From our early days as an academic CNS research organization in the 1980s, to the formation of INC in 1998, to where we are today, we ve continued to improve what we do.

We understand that cancer is not one disease, but a category of widely varying diseases, each with its own specialized scientific complexities, patient populations and range of treatment options. Our Oncology and Hematology practice is dedicated to the execution of clinical trials in these complex indications and is staffed by dedicated professionals with backgrounds in oncology drug development in academia, industry and CRO settings. This expertise, combined with INC Research s Trusted Process methodology for delivering dependable trial outcomes, provides the resources, clinical expertise and development know-how to help our clients with every facet of their Oncology research.

We are currently looking to strengthen our Project Management team in North America and are seeking Project Managers for our CNS Business Unit to be home-based regional employees.

QUALIFICATIONS:

Project Administration - Acts as a primary liaison between the Company and the Customer to ensure study launch, conduct, and closeout according to the Customer s and the Company's contractual agreement. Coordinates project organization, implementation, and management activities between all Company operations and the client. Manages the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses. Oversees and tracks site payment issues as required. Alerts Finance on the need for Customer invoicing. Oversees the regulatory document collection and submission process. Ensures project documentation, including Trial Master Files are complete and audit ready. Assists in the negotiation and contracting process with outside vendors (labs, printers, etc). May perform or oversee site feasibility assessments. Reviews protocol, Case Report Forms and edits specifications for consistency within each document, cross-checking these documents against each other. Develops and maintains project plans for the study in accordance with Standard Operating Procedures (SOPs) and Work Instructions (WI). Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools. Produces and distributes status, resourcing, and tracking reports, and functional area plan to appropriate team members and senior management. Performs ongoing review of project financial status of studies. Alerts senior management to potential issues and ensures necessary corrective action is taken.

* Communication - Independently prepares and presents study material at client meetings and communicates outcomes to project team at review meetings. Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, project management, monitoring, and/or training plans.

Why choose us:
It takes skill and passion to develop medicines the way we do. Don t worry if you ve got the passion part, we ll help you develop the skills you need to enhance every aspect of your career in the clinical research industry. We ve got an attitude at INC: Can do, I own it. Absolutely everyone has ownership of what they do here; and because we re given the freedom and responsibility to really own our projects, we can take them to new levels. This means we can take our careers wherever we want them, too.

We were ranked Top CRO to work with in the CenterWatch 2015 Investigative Site Relationship Survey (a biannual survey of over 2,000 sites worldwide).