Clinical Services Project Manager I

Spectraforce Technologies, Inc.; Tucson (AZ); Remote; USD 70,000 - 100,000; Full time

Job summary

Spectraforce Technologies, Inc. is seeking a Clinical Services Project Manager I to lead multiple clinical and lab services projects from initiation through contract completion in a fully remote role.

The candidate will apply project management best practices to deliver on time, within budget, and with high customer satisfaction while coordinating cross-functional teams and maintaining rigorous documentation for pharma partners.

Qualifications

• Bachelor's Degree in a related field or equivalent combination of education and work experience (Required)
• Master's Degree in Project Management or Clinical Research training/certification preferred
• 2 years of project/clinical trial coordination/management experience in regulated CRO/pharma with documentation (Required)
• Experience with clinical projects requiring rapid milestones (Required)
• Clinical trial management knowledge and bio-sample management familiarity preferred
• PMI process knowledge desired (Preferred)
• Industry knowledge in diagnostic/pharmaceutical areas preferred
• Strong problem solving and cross-functional coordination skills (Required)
• Familiarity with clinical trials management (Required)
• Understanding of Quality and Regulatory processes (Required)
• Knowledge of clinical sample flow and testing (Required)
• Excellent written/verbal communication and meeting facilitation (Required)
• Proficiency with MS Office and collaboration tools (Required)
• Interpersonal skills and team leadership (Required)
• Ability to manage time pressure while ensuring data quality (Required)
• Ability to manage projects with milestone-driven testing and data reporting (Required)
• Experience interfacing with laboratory, scientific, and medical staff (Required)
• Agile methodologies experience preferred

Responsibilities

• Manages multiple clinical testing and lab services projects from initiation to contract completion under supervision
• Acts as primary point of contact to pharma customers
• Coordinates timelines for all project functions
• Develops project plans and establishes timelines
• Manages cross-functional plan execution and tracks activity progress
• Identifies gaps and bottlenecks and challenges assumptions
• Oversees sample process flow and reporting accuracy
• Implements best practices within the clinical sciences team
• Guides cross-functional interactions to meet deadlines
• Interfaces with CROs, site investigators, and client counterparts as contact
• Manages meeting activities and minutes
• Tracks and communicates project reports and study data to clients
• Performs other duties as assigned

Skills

Project management

Regulatory knowledge

Communication skills

Team leadership

Time management

Agile methodologies

Education

Bachelor's degree in related field

Master's degree in PM or Clinical Research

Tools

Microsoft Excel

Microsoft Word

PMI process knowledge

Job description

Position Title: Clinical Services Project Manager I

Work Location: Remote (must reside in regions where The Organization is registered to do business)

Assignment Duration: 12 Months

Work Arrangement: Fully Remote

Position Summary

Under general supervision, manages multiple clinical and lab services projects of less complex nature from initiation through contract completion. Applies project management skills and experience in delivering projects on time, within budget and with high customer satisfaction. Facilitates cross-functional interactions to complete the assigned projects within the deadline and compliance with pharma services plan.

Background & Context

This job is second in the Clinical Sciences project management job series comprising four levels. The employee is assigned on projects that may be limited in scope and/or of low to medium complexity. It may involve collaboration with other Clinical Sciences Program Specialist Senior or Clinical Sciences Program Manager.

Key Responsibilities

• 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 Roche clients.
• Other duties as assigned by management.

Qualification & Experience

• Bachelor's Degree in a related field or equivalent combination of education and work experience in a related field (Required)
• Master's Degree Specific Project Management Training, or Clinical Research training and/or certification. (Preferred)
• 2 years of project and/or clinical trial coordinator/management experience in a regulated, CRO, diagnostic, and/or pharmaceutical industry with regulated documentation (Required)
• Experience with clinical projects that require rapid activity/milestone achievement. (Required)
• Experience in clinical trial management and knowledge of bio-sample (clinical testing) management and process flow preferred. (Preferred)
• Previous experience with standard project management process (PMI) desired. (Preferred)
• Diagnostic and/or Pharmaceutical industry and relevant diagnostic area knowledge preferred. (Preferred)
• Possesses problem solving skills and ability to coordinate project related activities. (Required)
• Familiarity with management of Clinical Trials. (Required)
• Understanding of Quality and Regulatory processes. (Required)
• Knowledge of clinical sample process flow and testing. (Required)
• Strong Written and verbal communication skills and meeting facilitation skills. (Required)
• Proficiency with word processing, spreadsheet, database and email software (e.g., Microsoft Excel, Microsoft Word). (Required)
• Possesses interpersonal skills and ability to work in a team environment. Displays leadership skills. (Required)
• Ability to work under time pressure while maintaining high standards of precision and data quality. (Required)
• Ability to manage projects with activity/milestone achievement to complete clinical study testing and data reporting to pharma partners. (Required)
• Ability to apply specialized knowledge and skills in the functional areas, particularly interfacing with laboratory, scientific, and medical staff. (Required)
• Experience with Agile methodologies preferred

Working Conditions & Physical Demands

Travel Requirements - as needed