FSP-Senior Bioanalytical Study Manager

Thermo Fisher Scientific•Morrisville, NC

7d•Onsite

About The Position

The Senior Project Manager - Labs leads and has direct oversight for a portfolio of projects for a specific client and is accountable for overall project/portfolio performance. Proactively identifies resources, budgets projects, prioritizes client's portfolio in line with site-wide portfolio of projects and is the primary operational interface between PPD and the client. Negotiates and makes real-time decisions with the client. Provides internal consulting on project management issues and identifies opportunities for process and efficiency improvement. Acts as chief liaison to the operational personnel of major clients and is responsible for large study programs. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

Requirements

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 5+ years’) or equivalent combination of education, training, & experience.
Strong science and/or business acumen
Strong verbal, written and presentation skills
Superior time management, planning, and organizational skills
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
Strong client relationship management skills
Ability to work effectively with multi-level teams
Ability to work in a fast-paced undefined environment
Strong negotiation skills

Responsibilities

Provide oversight and coordination of client portfolio. Provide oversight to internal departments and external clients to ensure the project requirements are understood, agreed and followed at all times, requiring negotiating and real-time decision making with the client.
Facilitate the flow of technical and clinical laboratory information to all stakeholders (investigational sites, sponsors, and non-technical personnel).
Consult and utilize, where appropriate, the scientific input of laboratory management and technical staff to assist the client with management of the project.
Prepare the project specification documents and follow their preparation according to budgets and contracts.
Maintain at all times an updated project master file with version controls for specifications, budgets, and contracts.
Ensure sponsors have authorized and signed off the most recent versions of all documents and that a contract exists prior to delivering any services.
Assure compliance with FDA and Good Clinical Practice guidelines as appropriate, PPD SOPs, personnel policies and procedures, PPD Exposure Control Plan, and applicable regulations regarding the transport of biological specimens.
During initial review of project documentation, consult with internal groups and support staff regarding procedural and budgetary items and the necessity for changes due to any subsequent project documentation amendments.
Obtain other functions' commitment to close gaps and address issues timely and effectively.
Serve as chief liaison between sponsor and all PPD internal departments performing the required tasks during all project phases.
Control, manage, and follow day-to-day activities during the course of the project to resolve any issues and answer queries.
Actively consult with IT and data management development groups in the design, validation, and implementation of new software and functionalities pertinent to project management activities.
Consult with BD and finance staff during initial project documentation review on standard services and costs, support RFP feasibility assessments, advise on possible solutions if needed, and draft responses for proposals.
Take responsibility for accurate invoicing and coordinate with AD of finance for all billing/invoicing for the client's portfolio of projects.