Project Manager – Central Labs

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.

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.

We are currently hiring for Associate Project Manager – Labs (Level I), Project Manager – Labs (Level II), and Project Manager GCL (Level III).

Discover Impactful Work:

Coordinates and manages clinical trials from start up through close out activities for the Global Central Labs 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.

A day in the Life:

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.

Education

Bachelors degree or equivalent and relevant formal academic / vocational qualification

Experience

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.

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

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

Working 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.

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.)

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.com

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.

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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.