QUALIFICATIONS

Pref Bachelor’s Degree in a related field is required
Master’s Degree education and work experience in a related field
Specific Project Management Training, or ClinicalResearch training and/or certification.
2 years of project and/or clinical trial coordinator/management experience in a regulated, CRO, diagnostic, X and/or pharmaceutical industry with regulated documentation Experience with clinical projects that require rapid activity/milestone achievement. Experience in clinical trial management and knowledge of bio-sample (clinical testing) management and process flow preferred.
Previous experience with standard project management process (PMI) desired. Diagnostic and/or Pharmaceutical industry and relevant diagnostic area knowledge preferred.

Knowledge, Skill or Ability

• Possesses problem solving skills and ability to coordinate project related activities. Familiarity with management of Clinical Trials.
• Understanding of Quality and Regulatory processes.
• Knowledge of clinical sample process flow and testing.
• Strong Written and verbal communication skills and meeting facilitation skills.
• Proficiency with word processing, spreadsheet, database and email software (e.g., Microsoft Excel, Microsoft Word).
• Possesses interpersonal skills and ability to work in a team environment.
• Displays leadership skills. Ability to work under time pressure while maintaining high standards of precision and data quality.
• Ability to manage projects with activity/milestone achievement to complete clinical study testing and data reporting to pharma partners. Ability to apply specialized knowledge and skills in the functional areas, particularly interfacing with laboratory, scientific, and medical staff.

TB_P

• Manages multiple clinical testing and lab services projects from initiation through contract completion under supervision of Program Manager.
• Acts as primary point of contact to Pharma customers.
• Performs tactical coordination of timelines for all projects and functions within CDx Pharma Services and:
• Develops project plans, establish and coordinates timelines for assigned projects and functions;
• Manages execution of cross-functional plans and tracks progress of activities;
• Identifies gaps, potential bottlenecks or delays and challenge assumptions.
• Oversees and guides day to day activities of sample process flow and accurate reporting of results. Implements / pulls in best practices within the clinical sciences team; fosters continuous improvement by ensuring knowledge and experience exchange Guides and manages cross-functional interactions to complete the assigned projects within the deadline.
• Interfaces with resources outside of the company (Contract Research Organizations (CROs), site investigators, client counterparts, etc.) and serves as single point of contact with Pharma and Roche clients
• Manages meeting activities such as setting agendas, organizing meeting time and editing meeting minutes.
• Tracks, maintains and communicates project reports and clinical study data to Pharma and clients. Other duties as assigned by management