Project Design Manager I

Work Schedule

Environmental Conditions

Job Description

Our PPD Laboratory Services team has a direct impact on improving patient health through the expertise of scientists industry thoughtleaders and therapeutic experts. As the world leader in serving science our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Title: Project Design Manager

Division/ Dept.: Clinical Research Group/ Global Central Labs

Location: Remote (United States)

Discover Impactful Work:

TheProject Design Managerindependently 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 thirdparty 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 crossdepartmentally 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 departments 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

• 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.
• 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 selection decisions

Knowledge Skills Abilities

• 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 problemsolving 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

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.

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 100000 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!

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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