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Registry Study Project Manager Job in Mason, Ohio US

Registry Study Project Manager

Atricure, Inc. - Mason, OH

Posted: 2/16/2024 - Expires: 5/16/2024

Job ID: 269895129

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Job Description

Registry Study Project Manager

Cincinnati, OH, USA * Minneapolis, MN, USA * Minnesota, USA * Ohio, USA
Req #1859

Friday, February 9, 2024

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.

POSITION SUMMARY:

The Senior Registry Specialist / Registry Study Project Manager will lead and manage the daily activities for one or more AtriCure sponsored Registries and Registry projects in support of strategic real-world evidence (RWE) initiatives to meet company goals. As a member of the Scientific Affairs team, the role will report to the Manager, Global Registries, and collaborate closely with vendors, site research staff, Clinical Operations, and Data Management teams at AtriCure.



ESSENTIAL FUNCTIONS OF THE POSITION:




Supports development and management of Registry and Registry Projects in alignment with the strategic business needs, such as but not limited to the Regulatory submissions, Publications to support Reimbursement, Claims, and Marketing Statements,
Develops and updates the Registry protocol, Case Report Forms (CRF), Informed Consent Forms (ICF), and other documentation to align with strategic needs and steering committee guidance.
Assist with Registry data usage projects, including relevance assessments and preliminary data analysis, supporting ongoing AtriCure RWE initiatives.
Collaborate cross-functionally to maintain timely and accurate communication with site staff, drive and meet activation and enrollment targets, and resolve site-related issues (e.g., data queries, compliance, enrollment, and activation barriers)
Lead Registry Core Team meetings and participate in Registry Steering Committee meetings, document meeting minutes, and follow up on the action items.
Work with AtriCure's Legal, Compliance, and Clinical Operations teams to address contract and budget escalations as needed.
Maintain Registry budget and collaborate with AtriCure Finance team on monthly spending and quarterly forecasts.
Liaise with the AtriCure Data Management team and external vendors on database builds data migrations, and ongoing database maintenance activities.
Assist Registry Manager with site/investigator recruitment, outreach activities, and intro call follow-up.
Lead Registry Site Initiation Visit (SIV) and maintain site personnel access within the registry database.
Maintain Registry Clinicaltrials.gov updates and study-level central Institutional Review Board (IRB) approvals
Standard Operating Procedure (SOP), Work Instructions (WI), and Registry template development and maintenance
Liaison with vendors and internal stakeholders on Registry data analysis and data monitoring plan.
Ensure Registry documentation and Trial Master File (TMF) are in an audit-ready state
Provide input on the project budget and strategic plan.
Facilitate the preparation of project and study newsletters, correspondence, study documents, and progress reports



ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:


Regular and predictable work performance
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
Additional duties as assigned



BASIC QUALIFICATIONS:


Bachelor's degree with at least 5 years of experience in clinical research (medical device experience preferred).
Strong understanding and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable)
Basic data analysis skills (Excel Pivot Tables, Python, Power BI etc.)
Ability to multitask, prioritize and meet deadlines in a fast-paced environment
Collaborative approach in working with cross functional teams
Ability to write and communicate professionally with minimal input
Excellent interpersonal communication skills
Ability to travel approximately 10%



PREFERRED QUALIFICATIONS:


Experience in the domain of cardiac arrhythmia

OTHER REQUIREMENTS:


Ability to regularly walk, sit, or stand as required
Ability to occasionally bend and push/pull
Ability to pass pre-employment drug screen and background check

#LI-RS1

AtriCure has a variety of benefits available for US based employees and their families. Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 20 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more. Corporate-based employees also have full access to our on-site fitness center and cafeteria. To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/benefits AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov/ AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).

Other details

Job Family
Scientific Affairs

Job Function
Scientific Affairs

Pay Type
Salary

Employment Indicator
Non Manager

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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status or status as an individual with disability.

Job Summary

Employment Type:
Full Time Employee
Job type:
Federal Contractor
Skill Based Partner:
No
Education Level:
Bachelor's degree
Work Days:
Mon, Tue, Wed, Thu, Fri
Job Reference Code
78263975
Salary
N/A
Licenses / Certifications:
N/A
Display Recommended WorkKeys®Recommended WorkKeys®:
Applied Math: 4
Graphic Literacy: 5

Workplace Documentation: 5