Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

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.

• 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.
• Manages allocated studies according to timelines and quality standards. Coordinates activities of all functional departments and vendors involved in the project. Works with team and management to develop plans/guidelines for project implementation using PPD tools. Monitors and analyzes project status to ensure successful completion of project parameters, milestones, timetables.
• Acts as liaison between Sponsor and PPD by facilitating the flow of information between PPD and client. Provides Sponsor with timely project updates, project related fiscal information, ensures correct protocol interpretations, and obtains direction and feedback on implementing scope of work. May discuss and obtain feedback from Sponsors regarding PPD's performance to date.
• Plans and communicates to team members study specific tasks and priorities for projects. Liaises with managers in all functional areas within PPD to optimize Performance and utilization of the project team members. Appropriately escalates any issues or potential issues to management for all project related issues.
• Works closely with other departments to manage financial and contractual aspects of the study including establishing and recognizing financial milestones for invoice and subcontractor purposes, subcontracting with third-party service providers, approving subcontractor invoices, and establishing proper accrual for investigator grants. Works with the project team to establish appropriate controls to ensure that project resources and expenses are aligned with budgets.
• Progressive and/or more extensive job duties and responsibilities may be expected with increasing project management level.

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification

• Previous experience that provides the knowledge, skills, and abilities to perform the job
• Associate Project Manager - Labs (Level I): Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years') or equivalent combination of education, training, & experience.
• Project Manager - Labs (Level II): Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years) or equivalent combination of education, training, & experience.
• Project Mgr GCL (Level III): Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years) or equivalent combination of education, training, & experience.

• Experience supporting central laboratory project management and/ or laboratory related project management experience highly preferred
• Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines
• Effective project management and organizational skills
• Good computer skills
• General knowledge of clinical trial processes and programs
• Strong attention to detail and problem solving skills
• Good written and verbal communication skills
• Ability to effectively conduct oral presentations
• Demonstrated experience in identification and resolution of technical problems in a professional environment
• Ability to maintain a high degree of confidentiality with clinical teams
• Ability to attain, maintain and apply a working knowledge of applicable procedural documents
• Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others
• Extensive knowledge and experience in Project Management in Global Central Lab environment
• 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
• Strong client relationship management skills
• Ability to work effectively with multi-level team
• Knowledge of the key principles of cross functional project management (Time, Quality, Cost)
• Fundamental financial acumen
• Displays effective communication skills (listening, oral, written) and can communicate in English language (oral, written)
• Sound interpersonal skills, is flexible and adapts to changing situations
• Ability to persuade, convince, and influence or impress others
• Organized, proficient at multitasking with good attention to detail
• Ability to delegate, effectively prioritizes own and workload of project team members
• Ability to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.
• Understanding and appreciation of clinical research/development, including medical and therapeutic areas, phases and medical terminology
• Knowledge/understanding of clinical development guidelines and directives

• 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.
• May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel. (Recruiter will provide more details.)