Clinical Project Manager Investigator Initiated Studies

Acton, MA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Note : Please inform the candidates that they can expect a call from HonorVet Technologies for initial screening round. Please provide candidates availability in the iLabor comment box while submitting the candidate. Formatted resume is required.

Note: Format details Candidate Name Calibri 14/Centre Layout Margin Narrow Paragraph setting No space/0 spacing between lines. Font Calibri 11 The resume should not be longer than 4-5 pages. The summary should be in 4 to 5 lines.

Preference for candidates local to Acton MA; open to remote.
Job Duration: 05 Months
20 hrs/week minimum. Can go up to 40/week based if available.

Responsibilities:

Liase with the Medical Affairs team to manage request for study devices and device data for Investigator Initiated Studies
Liase cross-functionally with the Manufacturing R&D and Engineering teams to procure study devices for Investigator Initiated Studies
Liase with the Cloud team to set up remote monitoring capabilities and export device data to relevant stakeholders for Investigator Initiated Studies.
Ensure appropriate agreements and contracts are executed.
Determine the priority of requests to ensure efficient resource management.
Aid in the preparation of project status presentations to Management regularly.
Prepare project summary reports develop and track project plans.
Manage the maintenance of a shared site that organizes and updates central project documents and manage access to the site for users.
Ensure timelines are being managed and communicated to key stakeholders.
Review study protocols and other documentation to determine the appropriate quantity of devices needed per study.
Estimate the total cost of devices and resources required for each study
Support other clinical study activities within the department as needed.
Willing to come into the Acton office as needed.
Perform other duties as required.

Education and Experience:

Bachelors Degree (preferably in Biomedical Engineering or Life Science field)
3-7 years of medical device or drug related clinical experience or an equivalent combination of education and experience.
At least 2 years project management experience is required
Biomedical engineering and/or diabetes therapeutic experience highly desired.
Must have analytical skills be detail oriented and have good interpersonal skills.
Knowledge of agency guidelines and requirements.

Skills/Competencies:

Excellent written and effective verbal communication skills.
Proficient project management skills.
Ability to prioritize multiple timelines and tasks.
Ability to communicate at all levels of an organization.
PC skill word processing spreadsheet database timeline software.
Internet search and utilization.
Flexible and able to work in a fast paced environment.
Team player.

Physical Requirements:

Estimated travel (domestic and international) is approximately 10% per year.

Note : Please inform the candidates that they can expect a call from HonorVet Technologies for initial screening round. Please provide candidates availability in the iLabor comment box while submitting the candidate. Formatted resume is required. Note: Format details Candidate Name Calibri 14...

Preference for candidates local to Acton MA; open to remote.
Job Duration: 05 Months
20 hrs/week minimum. Can go up to 40/week based if available.

Responsibilities:

Liase with the Medical Affairs team to manage request for study devices and device data for Investigator Initiated Studies
Liase cross-functionally with the Manufacturing R&D and Engineering teams to procure study devices for Investigator Initiated Studies
Liase with the Cloud team to set up remote monitoring capabilities and export device data to relevant stakeholders for Investigator Initiated Studies.
Ensure appropriate agreements and contracts are executed.
Determine the priority of requests to ensure efficient resource management.
Aid in the preparation of project status presentations to Management regularly.
Prepare project summary reports develop and track project plans.
Manage the maintenance of a shared site that organizes and updates central project documents and manage access to the site for users.
Ensure timelines are being managed and communicated to key stakeholders.
Review study protocols and other documentation to determine the appropriate quantity of devices needed per study.
Estimate the total cost of devices and resources required for each study
Support other clinical study activities within the department as needed.
Willing to come into the Acton office as needed.
Perform other duties as required.

Education and Experience:

Bachelors Degree (preferably in Biomedical Engineering or Life Science field)
3-7 years of medical device or drug related clinical experience or an equivalent combination of education and experience.
At least 2 years project management experience is required
Biomedical engineering and/or diabetes therapeutic experience highly desired.
Must have analytical skills be detail oriented and have good interpersonal skills.
Knowledge of agency guidelines and requirements.

Skills/Competencies: