Project Design Manager

Title: Project Design Manager

Division / Dept.: Global Central Lab/ Project Management

Location: Remote/Home Based (United States)

Note: Full time, Permanent, Benefits, 401K

Summarized Purpose: The Associate Project Design Manager independently reviews clinical trial protocols and interprets Central Lab responsibilities based on protocol definitions and budgeted services. The ability to work on a team, as well as independently, while maintaining clear communication and attention to detail is key to this role!

• Collaborates with 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.
• Advise Project Managers on procedural and budgetary items and the necessity for change due to database configuration requirements.

Why PPD? At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer:

• Continued career advancement opportunities
• Complete a project management bootcamp training program
• Work with your dedicated mentor and have opportunities to become a mentor
• Create a work schedule that ensures you are meeting your work/ life balance needs with the ability to have flexible work from home schedule

Company Overview: PPD is part of Thermo Fisher Scientific. As the world’s leader in serving science, our professionals develop critical solutions—and build rewarding careers. We offer services and products that help customers around the globe in laboratories and clinics, on production lines and out in the field.

Additional Job Tasks:

• 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 time lines 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.

Education and Experience:

• Bachelor's degree in computer science, statistics, biostatistics, mathematics, biology or other health related field or equivalent experience that provides the skills and knowledge necessary to perform the job.
• 1 year experience with data collection or analysis, or working with relational databases.
• Central Laboratory experience preferred
• Med Tech/ Clinical Lab Scientist experience preferred

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills,and abilities necessary to perform the essential functionsof the job.Years of experience are not to be used as the only determining factor in establishing the job classor making employment selection decisions.

Knowledge, Skills and Abilities:

• Good oral and written communication skills
• Good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
• Ability to maintain a high degree of confidentiality with clinical data and client's proprietary data
• Ability to attain, maintain and apply a working knowledge of GCPs and applicable SOPs
• Strong attention to detail and problem-solving skills
• Positive attitude, enthusiasm toward work, and the ability to work well with others.
• Good computer skills
• Knowledge of relational database systems (RDBMS) and structures

Working Environment:
PPD 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.)

PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.