Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them. Our team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.
Group/Division Summary:Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations
Discover Impactful Work:
Join Thermo Fisher Scientific Inc. as a Labs Project Manager II in Richmond, VA! This outstanding opportunity allows you to be part of a world-class team that successfully coordinates clinical trial projects. We strive for flawless execution, ensuring our clients' needs are met with proven solutions.
A day in the life: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, PPD SOP’s, personnel policies and
procedures, PPD 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 PPD 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 queriesActively 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.
Keys to Success:
Education
Bachelor's degree or equivalent and relevant formal academic / vocational qualificationExperience
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’) or equivalent combination of education, training, & experience.Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.Knowledge, Skills and Abilities:
Strong verbal, written and presentation skillsSuperior time management, planning, and organizational skillsCompetent with specific computers and enterprise applications, including office productivityAbility to program the IT system according to protocol requirementsProven analytical skillsDemonstrated compliance with procedures and policiesAbility to perform multiple tasks effectively in a stressful environmentExtensive knowledge and experience in Project ManagementStrong client relationship management skillsAbility to work effectively with multi-level teamsWork EnvironmentThermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.Able to work upright and stationary for typical working hours.Ability to use and learn standard office equipment and technology with proficiency.Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.May require travel. (Recruiter will provide more details.)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!