Manages clinical and lab services projects with broad and large complexity and scope. Applies advanced project management and leadership skills and experience in delivering complex, strategic projects on time, and with high customer satisfaction. Serves as Single Point of Contact (SPOC) for client and team management. Coaches and mentors team members.
Manages projects within a program with broad and large complexity and scope and serves as program SPOC for client management.
Manages tactical and strategic coordination of timelines for all projects and functions within CDx Pharma Services and:
- Develops project plans, establish and coordinates timelines for assigned project and functions
- Manages execution of cross-functional plans and track of progress of activities
- Identifies gaps, potential bottlenecks or delays and challenge assumptions
- Proposes options to close gaps and get projects back on track.
Oversees CDx clinical and lab services studies from concept through contract completion and directly manages the day-to-day activities of the program or project including establishment and oversight of timelines and budgets.
Guides team processes, ensuring consistency, transparency and optimization.
Resolves escalated operational issues and questions related to projects and/or programs. Resolves operational issues and responds to questions related to projects managed by direct reports.
Implements / pulls in best practices within clinical sciences team and drives continuous improvement by ensuring knowledge and experience exchange.
Manages the Sample Process Flow from sample receipt to result reporting and project execution.
Plans, organizes, attends and leads program and project-specific meetings; reviews and edits meeting minutes.
Tracks, maintains, and communicates project reports and clinical study data to Pharma and Roche clients.
Leads quality assurance/quality control and/or data review process as necessary.
Oversees the work of clinical sciences team members. Provides input to manager regarding performance. Coaches and mentors team members.
Required: Bachelor's Degree in a related field or equivalent combination of education and experience.
Master's Degree strongly preferred. Specific Project Management training, or Clinical Research training and/or certification strongly preferred PLUS
5 years of experience in a regulated, CRO, diagnostic, and/or pharmaceutical industry with regulated documentation and Project Management; 6 years of experience preferred.
Experience with quality and regulatory processes.
Experience with project and/or clinical trial management.
Prior people management and/or leadership experience highly preferred.
Knowledge, Skills and Abilities
- Knowledge of bio-sample (clinical testing) management and process flow in a clinical trial setting.
- Knowledge of diagnostic and/or pharmaceutical industry and translational/companion diagnostics.
- Knowledge of diagnostic testing/medical device regulations.
- Knowledge and understanding of standard project management process (PMI) and clinical trial management.
- Knowledge of IRB/Ethics committee oversight processes.
- Proficiency with word processing, spreadsheet, database and email software (e.g., Microsoft Excel, Microsoft Word).Ability to multitask and coordinate own day-to-day activities. Ability to work under time pressure while maintaining high standards of precision and data quality., Ability to apply specialized knowledge and skills in the functional areas, particularly interfacing with laboratory, scientific, and medical staff.
- Demonstrated experience in problem solving and providing oversight of complex projects, and/or programs-related activities. Excellent written and oral communication skills required. Strong negotiation and meeting facilitation skills. Displays effective interpersonal skills and ability to work in a team environment. Excellent Leadership skills.