Project Design Manager, Central Labs

Job Title: Project Design Manager, Central Labs

Job Location: Remote, Kentucky, USA

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level:

Work Schedule

Standard (Mon-Fri)Environmental Conditions

OfficeJob 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.

This is a fully remote role supporting our Global Central Laboratories. We welcome applicants from all locations within the US. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening.

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!

Key Responsibilities

• 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.

Qualifications:

Education and Experience

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

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

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, and Abilities:

• Familiarity with Clinical Trial Database within Central Laboratory environment strongly 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

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.)

Why Join Thermo Fisher Scientific?

When you join us, you become part of a global organization committed to enabling customers to make the world healthier, cleaner, and safer. You’ll collaborate with industry-leading experts, contribute to groundbreaking clinical research, and grow within an environment that values innovation, accountability, and continuous development.

If you’re ready to lead complex clinical laboratory projects and make a measurable impact, we encourage you to apply.

Apply today and help deliver tomorrow’s breakthroughs.

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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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Originally posted on Himalayas