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Job DescriptionThermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.Title: Sr Project Manager - LabsDepartment: Small Molecule/ GMP LabsLocation: RemoteDivision Specific Information:Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.Discover Impactful Work:Manages 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 finds opportunities for process and efficiency improvement. Acts as chief liaison to the operational personnel of major clients and is responsible for large study programs.A day in the Life:
Provides oversight and coordination of client portfolio. Provides oversight to internal departments and external clients to ensure the project requirements are understood, agreed, and followed at all times, this requires negotiating and real time decision making with the client. Facilitates the flow of technical and clinical laboratory information to all team members (investigational sites, sponsors, and non-technical personnel). Consults and uses, where appropriate, the scientific input of laboratory management and technical staff to assist the client with management of the project.
Prepares the project specifications documents and follows the preparation according to budgets and contracts. Maintains at all times an updated project 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 as appropriate, PPD SOP''s, personnel policies, and procedures, PPD Exposure Control Plan and applicable regulations regarding the transport of biological specimens.
During initial review of project documentation, consults with internal groups and support staff regarding procedural and budgetary items and the necessity for change due to any subsequent project documentation amendments. Obtains other functions'' commitment to close gaps and address issues timely and effectively. Serves as chief liaison between sponsor and all PPD internal departments performing the required tasks during all project phases. Controls, manages and follows day to day activities during the course of the project to resolve any issues and answer queries.
Actively coordinates 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.
Responsible for accurate invoicing and coordinates with AD of finance for all billing/invoicing for the client''s portfolio of projects
Keys to Success:Education
Bachelor''s in a scientific discipline
8+ years experience in (pharmaceutical) project management
Executive level presentation experience
Knowledge, Skills, Abilities
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
Work Environment
Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
Occasional drives to site locations, occasional domestic travel.
Exposure to biological fluids with potential exposure to infectious organisms.
Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
Personal protective equipment required such as protective eyewear, garments and gloves.
Exposure to fluctuating and/or extreme temperatures on rare occasions.
BenefitsWe offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Apply today! http://jobs.thermofisher.comThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Accessibility/Disability AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process.This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Full-time