Labs Project Manager II - GPHS FSP

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll 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 lifechanging 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

This position is sitebased in Bethesda Maryland. Preferred candidates will have lab project management experience within government support or large hospitals/academic medical centers.

Discover Impactful Work:

As a Project Manager within our Labs you will monitor and lead all aspects of designated clinical trial protocols in client lab and be accountable for overall project performance and clients satisfaction by meeting their needs and expectations through the life cycle of the assigned clinical trials. You will provide internal consulting on project management issues and find opportunities for process and efficiency improvements. Acting as chief liaison to the operational personnel of major sponsors you will be 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 partners (investigational sites sponsors and nontechnical 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 SOPs 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 leads 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 Setup 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 backup for the (Associate) Director PM when needed.

Keys to Success:

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 (comparable to 2 years) or equivalent combination of education training & experience.

In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

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 requirement
• Proven compliance with procedures and policies
• Ability to perform multiple tasks effectively in a stressful environment
• Extensive knowledge and experience in Project Management in Global Central Lab environment
• Strong client relationship management skills
• Ability to work effectively with multilevel teams

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 and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds.
• Able to work in nontraditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements including infectious agents typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Benefits

We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forwardthinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• A choice of national medical and dental plans and a national vision plan including health incentive programs

• Employee assistance and family support programs including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave 3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short and longterm disability in accordance with company policy

• Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits please visit: Experience:

IC