At Thermo 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.
Location/Division 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 experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.
Title: Project Manager - Labs
Division/ Dept.: PPD/ Clinical Research Group/ Bioanalytical Lab
Office Status: Onsite, Monday-Friday
Location: Richmond, VA
Discover Impactful Work:
Monitors and manages all aspects of designated clinical trial protocols and is accountable for overall project performance and client's satisfaction by meeting their needs and expectations through the life cycle of the assigned clinical trials. 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 sponsors and is responsible for large study programs.
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 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.
Keys to Success:
Education
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Experience
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 election decisions.
Knowledge, Skills, 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
Strong client relationship management skills
Ability to work effectively with multi-level teams
Work Environment
Thermo 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.)
Benefits
We 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!
