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Avania Senior Project Manager in Massachusetts

A Senior Project Manager (PM) will be able to perform all functions PM level responsibilities more independently. A senior PM is mainly responsible to provide leadership in medical device clinical trial activities. The senior PM is responsible for implementing and managing the project planning; tracking of the clinical monitoring process; and administration and overview of clinical trials.

The position requires an independent role in project planning and monitoring with a proactive Management Team reporting function. This means that the senior PM can independently analyze project forecasts and trends and provide the Management Team with input that can be used for i.e. board meetings and business decisions.

The senior PM is able to perform the following:

• Business lead generation

• May lead bid defense meetings

• 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

• May assist Management Team in selecting, managing and evaluating contractors/Suppliers where it concerns the Clinical Department

• May assist Management Team with selection of new (internal or external) clinical staff

• May assist Management Team with performance of job appraisals of clinical staff

• Prepare PM update report

Financial:

• Prepare budgets and forecasts

• 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

Relevant degree in (para)medical life science or nursing preferred.

A minimum of 7 years of experience with performing clinical trials

A minimum of 2 years of demonstrated leadership as a PM with work experience in clinical research, in the medical device or biotechnology industry or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.

Demonstrated record as project manager in the Clinical field

Ability to independently analyze and provide GMT with project forecasts

Demonstrated record of business lead generation experience

GCP-ICH-E6, FDA regulations and ISO 14155,13485 and 9001 knowledge where applicable

Knowledge of regulatory regulations and guidelines on medical devices

Proficient in the use of computer and software systems (Microsoft Word, Excel, PowerPoint, email)

Ability to travel domestically and internationally

Fluent in English, spoken and written

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