Clinical Services Project Manager

Job Description

Job 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.

Distinguishing Characteristics:

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

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 CD 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 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.

Education and Certifications/ License:

• 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 Clinical Research training and/or certification.

Experience:

• 2 years of project and/or clinical trial coordinator/management experience in a regulated, CRO, diagnostic, 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.

Knowledge, Skills and Abilities:

• Diagnostic and/or Pharmaceutical industry and relevant diagnostic area knowledge preferred.
• 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.

Notes:

• ​​​​​​​Preference is local candidates, but will accept remote candidates with the ability to travel as required.