Job Summary
Job Description:
The Project Manager- Labs- Provides oversight and coordination of study initiation.
Reviews, interprets, translates and programs study protocols into a complete and accurate database.
Communicates with internal departments and external vendors and ensure the project requirements are understood, agreed and followed at all times.
Facilitates the flow of technical and clinical laboratory information to all stakeholders (investigational sites, sponsors, and non-technical personnel).
Consults and utilizes, where appropriate, the scientific input of laboratory management and technical staff to assist the client with management of the clinical trial.
• Prepares the study specifications documents and follows the preparation according to budgets and contracts. Maintains at all times an updated study master file with version controls for specs, budgets and contracts. Ensures sponsors have authorized and signed off most recent versions of all docs and that a contract exists prior to deliver any services. Assures compliance with FDA and Good Clinical Practice guidelines, Client SOP’s, personnel policies and procedures, Client Exposure Control Plan, IATA, and other regulations regarding the transport of biological specimens.
• During initial review of protocol, consults with internal groups and support staff regarding procedural and budgetary items and the necessity for change due to any subsequent protocol amendments. Obtains other functions’ commitment to close gaps and address issues timely and effectively. Serves as chief liaison between sponsor and all Client internal departments performing the required tasks during all study phases. Educates Investigator sites by delivering a protocol specific lab procedures presentation and demonstration during an investigator meeting. Controls, manages and follows day to day activities during the course of the clinical trial to resolve any issues and answer queries.
• Actively consults with IT and data management development groups in the design, validation and implementation of new software and functionalities pertinent to project management activities.
• Consults with BD and finance staff during initial project documentation review on standard services and costs, supporting RFP feasibility assessments. Advises on possible solutions if needed. Drafts responses for proposals.
• Guides and supports work flow of Projects Managers and Set-up Administrators with special attention to training junior personnel. Performs as a mentor and trainer for (newly assigned) Project Managers, identifies areas for development and efficiencies in performing tasks. Authors, reviews, revises and implements relevant procedural documents. Serves as a back-up for the (Associate) Director PM, when needed.
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’) or equivalent combination of education, training, & experience.
Knowledge, Skills and Abilities:
Strong verbal, written and presentation skills
Superior time management, planning, and organizational skills
Competent with specific computers and enterprise applications, including office productivity
Ability to program the IT system according to protocol requirements
Proven analytical skills
Demonstrated compliance with procedures and policies
Ability to perform multiple tasks effectively in a stressful environment
Extensive knowledge and experience in Project Management in Global Central Lab environment
Strong client relationship management skills
Ability to work effectively with multi-level teams
POSITION NOTE: Please login to your Virtual Vocations account to view the company information and application instructions
