Project Design Manager I

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them. Our team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

Group/Division Summary:

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:

The Project Design Manager independently reviews clinical trial protocols and interprets Central Lab responsibilities based on protocol definitions and budgeted services. In this position you will advise Project Managers on procedural and budgetary items and the necessity for change due to database configuration requirements. This role supports the Project Manager in the review of draft laboratory specifications document for consistency with protocol and budgeted requirements; provides feedback to the Project Manager regarding budget and/or protocol discrepancies, system design requirements, and/or concerns. The ability to work on a team, as well as independently, while maintaining clear communication and attention to detail is key to this role!

A day in the Life:

• Ensures consistency of database design across sponsors and/or programs.
• Configures Collection Flow Chart (CFC) based on protocol testing requirements, assay volumes, testing location, sample stability, and frequency of testing. Determines appropriate testing to sample allocation based on testing schedule, processing instructions, sample disposition, and third-party lab requirements.
• Configures Kit Specifications based on protocol testing requirements, assay volumes, testing schedule, testing location, sample stability, testing frequency, study population, assay platform, total allowable blood volume, sponsor/program requirements, as well as determining ancillary supply requirements based on matrices, time points, study population, and collection device requirements.
• Configures sample labels based on client needs and collection requirements.
• Attends internal and external meetings and teleconferences; provides Project Manager support during laboratory specifications development discussions with client.
• Works cross-departmentally to ensure study database design meets client needs, as well as internal requirements.
• Seeks input and guidance from project design leads and managers when necessary.
• Under general supervision and guidance from project design leads and managers, builds study database and creates study deliverables within the timelines established by the team and indicated by the contract.
• Supports Project Management group with the development and implementation of study database design modifications.
• Performs database modifications based on client requirements; updates CFC, Kit Specifications, and sample labels, as appropriate, based on database modifications.
• Monitors assignments and adjusts priorities and work schedule to meet deadlines and provide high quality deliverables.
• Completes additional tasks as needed to support project, client, and departmental objectives.
• Understands and follows department's working practice documents and SOPs, and contributes to their development as needed, as well as understands and follows appropriate corporate SOPs

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.
• 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 

• Good oral and written communication skills 
• Solid organizational skills and time management skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines
• Capable of maintaining a high degree of confidentiality with clinical data and client’s proprietary data 
• Strong attention to detail and problem solving skills
• Demonstrated positive attitude, enthusiasm toward work, and a good team player
• Solid understanding of relational database systems (RDBMS) and structures 
• Solid understanding of the identification and resolution of technical problems in a professional environment
• Firm understanding of the data exchange between applications is preferred
• Good understanding of web services and working with APIs is preferred

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!