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Senior Project Manager - Medical Devices - CRO

Company: Hirebridge
Location: Marlborough
Posted on: January 27, 2023

Job Description:

When You Need to Advance Your Career, It Takes Avania
Avania is a leading, global full-service contract research organization (CRO) focused on the management of clinical studies for medical devices. Avania supports medical devices, in vitro diagnostics, biologics, and device-drug combination products from innovation to commercialization with a customized approach
Avania comprises highly specialized regional team members working together on a global scale to improve the future of human health. We believe that collaboration yields the best results; you will get to work with experts across many specialties. Avania encourages cross-training and the exchange of knowledge and ideas to help employees grow and advance.
Avania are hiring - Senior Project Manager - Medical Device / CRO
The Senior Project Manager is responsible to provide leadership in clinical trial activities. The Senior Project Manager is responsible for implementing and managing the project planning; tracking of the clinical monitoring process; and administration and overview of clinical trials.
As a member of our Global Project Management team, the Senior Project Manager role will involve the following;
Supervise the Project Team to ensure trial deliverables are on time, within budget and in appropriate quality, in compliance with applicable SOPs, ISO14155 / ICH-GCP and all applicable (local) regulations
Project planning and tracking of trial progress of various international clinical trials, which includes:
Communication with Sponsor and other parties involved about project strategy and progress, timelines, issues, questions etc., and provide regular study updates
Ensure development of various project specific plans, such as project plan and monitoring plan
Planning and tracking of site activities, such as site selection, site visits, site management, co-monitoring and site close out
Manage communication between various departments within Avania and the Sponsor
Head project team meetings, sponsor meetings and other clinical staff meetings
Review of clinical trial documents
Represent the company externally where it concerns the Clinical Department, if requested
Identify training requirements and provide training on the job to (new) personnel and trial specific tasks.
Identify (potential) resource issues within the Clinical Department and report to the Management Team
Assist Management Team in selecting, managing and evaluating contractors/Suppliers where it concerns the Clinical Department
Assist Management Team with selection of new (internal or external) clinical staff
Assist Management Team with performance of job appraisals of clinical staff
Prepare Project update report
Financial:
Perform budget review of ongoing studies/projects
Assist the Management Team in preparing budgets and forecasts
Bid defense participation
Quality Assurance:
Ensure all clinical staff comply with applicable departmental standard operating procedures
Ensure maintenance (and timely review) of departmental standard operating procedures
Timely follow-up on audit actions as assigned
Performance of corrective/preventive actions as required
Ensure maintaining of personal and study specific training records
Preparation for audits and inspections and follow up thereof
Interface with QA on planning of internal audit, study audit and timelines for follow-up on audit reports
The Sr Project Manager position is an independent role in project planning and monitoring with a proactive Management Team reporting function. This requires the Sr Project Manager to act independently analyzing project forecasts and trends and provide the Management Team with input that can be used for i.e. board meetings and business decisions.

Keywords: Hirebridge, Boston , Senior Project Manager - Medical Devices - CRO, Healthcare , Marlborough, Massachusetts

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