Senior Clinical Project Manager

POSITION SUMMARY:

This position will be responsible for managing and meeting the objectives of AtriCure clinical study projects(s). The Senior Clinical Project Manager has a proven competency in clinical research with experience in all aspects of clinical trial execution from start up to data reporting / analysis.  This position is responsible for leading the execution of AriCure’s clinical study project(s) acting as the primary liaison with clinical study site(s), outsource partners and internally interfacing across all functional disciplines within the company.

ESSENTIAL FUNCTIONS OF THE POSITION:

Accountable for day-to-day management and execution all phases of the assigned clinical studies and programs globally, in accordance with strategy, project plans, and budget following applicable regulatory and standard operating procedures.

Manages all aspects of program activities including budget and project planning.

Oversee the planning and execution of clinical study(s) to ensure that deliverables are conducted with integrity, completed to achieve scheduled milestones and goals and within budget.

Coordinates and consults with the cross functional project team, clinical operations, project stakeholders and the clinical study team providing direction to internal and external study team members as required.

Monitors study progress from internal study team members and outsource partners for accuracy and trending.

Presents study plans, provides ongoing updates and progress reports to internal and external stakeholders.

Ensures adequate clinical data collection, follow-up compliance, and works with other functional stakeholders to address identified issues.

Assists in ensuring trial is “audit ready” at all times

Evaluates integrity and quality of clinical data in preparation for study summary reports for presentations, publications, and submissions.

Contributes to the development and implementation of site corrective actions to address any site compliance issues.

Oversees activities delegated by VP, Clinical Affairs and/or VP, Regulatory Affairs specific to the company’s clinical/regulatory submissions.

Leadership of internal clinical research teams and CROs to deliver on business objectives. Ensure that clinical trials are properly resourced, managed and executed in accordance with timelines and good quality practices.

Thorough understanding of project management tools/techniques in order to manage project timelines, milestones, deliverables, dependencies, risks, issues, budgets, actions, decisions, and communications.

Supports all company initiatives as identified and in support of the quality system and other regulatory requirements.

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

Advanced written and verbal communication skills.

Ability to gather information from multiple sources, analyze, integrate, and resolve any conflicting requirements, and drive the clinical affairs organization through any challenges to result in a successful clinical study.

Comprehensive knowledge of ISO (International Organization for Standardization), GCP (Good Clinical Practice), ICH (International Council for Harmonization), FDA (Food & Drug Administration) & other applicable regulations governing the conduct of clinical trials

Regular and predictable work performance

Ability to travel up to 30% depending on the phase of study execution.

Ability to work under fast-paced conditions

Ability to make decisions and use good judgment

Ability to prioritize various duties and multitask as required

Ability to successfully work with others

Ability to manage clinical affairs cross-functional team without direct influence and work in a matrixed environment without direct reporting authority.

Additional duties as assigned

BASIC QUALIFICATIONS:

Bachelor’s degree required, in the Sciences preferred, or demonstrated equivalent combination of education, training and experience.

Minimum 5 years project management experience directly supporting medical device clinical research or similar experience in medical/scientific area, plus 1-3 years of experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting.

PREFERRED QUALIFICATIONS:

Project management experience with medical device clinical trials.

Clinical budget management experience/financial acumen.

Auditing experience.

Regulatory experience.

Ability to maintain a strategic perspective and align activities with business vision and purpose.

Ability to respond flexibly and positively under conditions of uncertainty or change.

ACRP or equivalent license/certification.

PMP or equivalent license/certification.

OTHER REQUIREMENTS:

Ability to regularly walk, sit, or stand as needed

Ability to occasionally bend and push/pull as needed

Ability to pass pre-employment drug screen and background check

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