Job SummaryThe Project Design Manager is responsible for managing the setup and amendment of clinical trial projects. This role involves creating and amending operational documents, coordinating with internal teams, and ensuring client requirements are accurately translated into project deliverables. The Project Design Manager serves as a subject matter expert during internal and external discussions and contributes to process efficiency and quality standards.
Essential Duties and Responsibilities- Initial Setups & Amendments
- Create or revise the Operational Specification Documents (OSDs) to define client requirements for studies of varying complexities.
- Create or revise customized test requisitions, laboratory manuals, and collection kit specifications.
- Serve as a project contact with Sponsors and Contract Research Organizations (CROs) to maintain communication channels and adherence to timelines.
- Attend internal and external calls as a Subject Matter Expert for Project Initiation and provide necessary information to Project Managers.
- Provide regular status updates to Project Management and Client Services leadership on setup progress.
- Translate client requirements into actionable steps for problem-solving and issue resolution, often requiring creative solutions while adhering to internal standards.
- Understand and interpret project-specific budgets.
- Cross-Functional Coordination
- Interface with internal functional departments to complete or assist with database setup and communicate study needs to meet client expectations.
- Liaise with colleagues to confirm completion of all setup-related tasks.
- Assist with project-specific training for internal staff.
- Mentor and train new team members to ensure consistent knowledge transfer and adherence to best practices.
- Create or oversee development of training materials, templates, job aids, and SOPs.
- Perform additional related tasks as assigned to support departmental and organizational goals.
Education and Experience- Bachelor's degree (B.A./B.S.) from four-year college or university with minimum of 3 years' experience that is setup related experience and/or project management experience.
Associates degree (A.S) and 5-6 years central laboratory or related clinical experience, including at least 3 years' experience that is setup related experience and/or project management experience. Must be experienced in customer service and possess excellent organization and interpersonal, communication and problem solving skills.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Clinical Research, Central Lab, and/or Project Management experience outside of LabConnect will be considered.
Skills and Ability- Excellent attention to detail, strong planning and problem-solving skills.
- Excellent organizational and time management skills.
- Excellent listening and verbal comprehension skills, including ability to translate client needs to team members.
- Ability to make well-thought-out decisions and adapt to changing environments and requirements.
- Self-motivating and ability to work well independently as well as using a collaborative team approach.
- Ability to adhere to established timelines, processes and procedures.
- Customer service/client relationship management skills.
- Working knowledge of Microsoft Office applications including word processing, spreadsheets, and PowerPoint.
- Ability to read, analyze, and interpret general business periodicals, professional journals, or technical procedures.
- Ability to write business correspondence and procedure manuals.
- Ability to effectively present information and respond to questions from managers and clients.
- Ability to perform calculations and manage budgets.
- Ability to apply mathematical concepts to budget management for clinical trials and metrics analysis.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Supervisory Responsibilities: None
Physical Demands: While performing the duties of this job, the occupant is regularly required to:
- Prolonged periods of sitting at a desk and working on a computer.
- Prolonged use of computer and headphones for conference calls.
- Communicate effectively via phone, video, and email.
- Use hands and fingers to operate a computer and other office equipment.
- Specific vision abilities required by this job include close vision and ability to adjust focus.
Travel Requirements: Minimal
