Clinical Trial Coordinator
Job Summary
The Project Leadership Coordinator (PLC) supports the Path Lab PHCS Project Leadership organization to deliver complex Companion Diagnostic projects in collaboration with pharmaceutical partners and internal initiatives to deliver efficiencies at scale.
The PLC will assist with coordination, and delivery of, tactical tasks required to deliver complex Companion Diagnostic projects from Project Start through Product Launch and Commercialization.
The PLC must apply solid project coordination and leadership skills to help deliver Companion Diagnostic projects on time, within budget and with high customer satisfaction.
The PLC will assist in coordination and delivery of internal initiatives that drive efficiencies at scale across the PHCS organization.
Qualifications:
To perform this job successfully, an individual must be able to perform each responsibility satisfactorily.
The requirements listed below are representative of the knowledge, skills, and/or abilities required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities.
Formal Training/Education:
Bachelor's Degree
Other duties as assigned by management.
Master's Degree
Specific Project Management training, or Clinical Research training and/or certification preferred.
Years of Experience (2-5 Years):
Project and/or clinical trial coordinator/management experience in a FDA regulated, CRO, diagnostic, and/or pharmaceutical industry dealing with regulated documentation and processes .
Experience with clinical trial management and bio-sample (clinical testing) management and quality assurance.
Experience with projects that require rapid activity/milestone achievement.
Previous experience with standard project management process (PMI) desired.
Proficiency:
Knowledge of Diagnostic and/or Pharmaceutical industry and relevant diagnostic area.
Knowledge and understanding of Clinical Trials management and bio-sample (clinical testing) management and process flow.
Understanding of Quality and Regulatory processes .
Knowledge of IRB/Ethics committee, Regulatory (Pharma/Medical Device) oversight processes.
Intermediate:
Strong negotiation and meeting facilitation skills.
Strong written and verbal communication skills
Good leadership and project management skills.
Displays effective interpersonal skills and ability to work in a team environment
Proficiency with word processing, spreadsheet, database and email software (e.g., Google Mail, Google Calendar, Google Sheets and/or Microsoft Excel
Working knowledge of MS Project and/or Smartsheets
Microsoft Word, Laboratory Management Information Management Systems).
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 cross-functional team representatives.
Ability to identify, align, and execute process improvements to deliver efficiencies at scale
Job Summary
The Project Leadership Coordinator (PLC) supports the Path Lab PHCS Project Leadership organization to deliver complex Companion Diagnostic projects in collaboration with pharmaceutical partners and internal initiatives to deliver efficiencies at scale.
The PLC will assist with coordination, and delivery of, tactical tasks required to deliver complex Companion Diagnostic projects from Project Start through Product Launch and Commercialization.
The PLC must apply solid project coordination and leadership skills to help deliver Companion Diagnostic projects on time, within budget and with high customer satisfaction.
The PLC will assist in coordination and delivery of internal initiatives that drive efficiencies at scale across the PHCS organization.
Qualifications:
To perform this job successfully, an individual must be able to perform each responsibility satisfactorily.
The requirements listed below are representative of the knowledge, skills, and/or abilities required.
Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities.
Formal Training/Education:
Bachelor's Degree
Other duties as assigned by management.
Master's Degree
Specific Project Management training, or Clinical Research training and/or certification preferred.
Years of Experience (2-5 Years):
Project and/or clinical trial coordinator/management experience in a FDA regulated, CRO, diagnostic, and/or pharmaceutical industry dealing with regulated documentation and processes .
Experience with clinical trial management and bio-sample (clinical testing) management and quality assurance.
Experience with projects that require rapid activity/milestone achievement.
Previous experience with standard project management process (PMI) desired.
Proficiency:
Knowledge of Diagnostic and/or Pharmaceutical industry and relevant diagnostic area.
Knowledge and understanding of Clinical Trials management and bio-sample (clinical testing) management and process flow.
Understanding of Quality and Regulatory processes .
Knowledge of IRB/Ethics committee, Regulatory (Pharma/Medical Device) oversight processes.
Intermediate:
Strong negotiation and meeting facilitation skills.
Strong written and verbal communication skills
Good leadership and project management skills.
Displays effective interpersonal skills and ability to work in a team environment
Proficiency with word processing, spreadsheet, database and email software (e.g., Google Mail, Google Calendar, Google Sheets and/or Microsoft Excel
Working knowledge of MS Project and/or Smartsheets
Microsoft Word, Laboratory Management Information Management Systems).
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 cross-functional team representatives.
Ability to identify, align, and execute process improvements to deliver efficiencies at scale