Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Why Join Us?
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.
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, prioritises 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 sees 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 collaborators (investigational sites, sponsors, and non-technical personnel). Consults and utilises, 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 an updated project master file with version controls for specs, budgets and contracts. Ensures sponsors have authorised and signed off most recent versions of all docs and that a contract exists prior to deliver any services. Assures compliance with FDA, ICH and Good Clinical Practice guidelines, 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, 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 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 5+ years') or equivalent combination of education, training, & experience.
Knowledge, Skills, Abilities
Strong science and/or business acumen
Strong verbal, written and presentation skills
Superior time management, planning, and organizational skills
Proven problem solving skills
Demonstrated compliance with procedures and policies
Ability to perform multiple tasks effectively in a stressful environment
Extensive knowledge and proven leadership in Project Management
Ability to work effectively with multi-level teams
Ability to work in a fast-paced undefined environment
Strong negotiation skill
Understanding of laboratory requirements, ICH guidelines, USP requirements and FDA guidance
Understanding of basic budgeting and forecasting terms and definitions
Physical Requirements / 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 prioritising 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!
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.
