Clinical Quality Project Manager

Additional Location(s):US-MN-Maple Grove; Ireland-Cork; US-MA-Marlborough; US-MN-Arden Hills

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit- High Performance

At Boston Scientific well give you the opportunity to harness all thats within you by working in teams of diverse and high-performing employees tackling some of the most important health industry challenges. With access to the latest tools information and training well help you in advancing your skills and career. Here youll be supported in progressing whatever your ambitions.

About the role:
Assists the Clinical QA Manager in planning coordinating and executing clinical quality initiatives to ensure clinical activities are conducted in compliance with applicable regulatory requirements quality standards and internal procedures. This role is critical in ensuring the integrity of clinical research processes and the delivery of safe effective solutions to patients worldwide.

Work model sponsorship relocation:
At Boston Scientific we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

• Your responsibilities will include:
  Manage and deliver clinical quality projects and initiatives in support of clinical programs and organizational quality objectives.
• Plan track and report on project timelines deliverables risks and dependencies to ensure on-time execution.
• Partner with Clinical Regulatory and Quality stakeholders to ensure clinical activities comply with applicable regulations standards and internal procedures.
• Provide clinical quality oversight and guidance throughout study planning execution and close-out phases.
• Support implementation and maintenance of clinical quality systems processes and tools.
• Lead quality risk management activities including identification assessment mitigation and documentation of clinical risks.
• Support internal and external audits and regulatory inspections including preparation participation and follow-up actions.
• Drive investigation root cause analysis and CAPA activities related to clinical quality issues and deviations.
• Monitor and analyze clinical quality metrics and trends; escalate issues and recommend continuous improvement actions.
• Review and contribute to clinical documentation to ensure quality compliance and consistency with internal standards.
• Facilitate cross-functional communication and alignment to resolve quality issues and support project goals.
• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

Qualifications:

Required qualifications:

• Minimum of a bachelors degree or an associates degree with a minimum of 3 years professional experience.
• Minimum of 3 years experience in project management.
• Minimum of 7 years experience in clinical quality assurance clinical research or a related field within the medical device or pharmaceutical industry.
• Experience working in FDA-regulated environments (medical devices pharmaceuticals or biologics).
• Experience in either clinical or quality functions.
• Strong knowledge of GCP ISO standards and global regulatory requirements related to clinical research.
• Experience leading clinical quality projects and managing quality systems or initiatives.
• Willingness to travel up to 20% domestically and/or internationally.
• Strong knowledge of risk management processes and CAPA methodologies.
• Excellent interpersonal and communication skills with the ability to work cross-functionally.
• Ability to work independently and manage multiple priorities in a fast-paced environment.

Preferred qualifications:

• Bachelors degree with a minimum of 3 years professional experience that includes project management.
• Clinical quality experience.
• Experience in pharmaceuticals and/or biologics in addition to medical devices.
• Experience working with CROs and clinical vendors.
• Prior experience supporting audits and regulatory inspections.
• Experience in a matrixed global organization.
• Experience contributing to or reviewing clinical study documentation for quality and compliance.

Requisition ID:622791

The anticipated annualized base amount or range for this full time position will be $ to $ plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC which can be reviewed at . Actual compensation will be commensurate with demonstrable level of experience and training pertinent education including licensure and certifications and other relevant business or organizational needs.

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

As a leader in medical science for more than 40 years we are committed to solving the challenges that matter most united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives create value for our customers and support our employees and the communities in which we operate. Now more than ever we have a responsibility to apply those values to everything we do as a global business and as a global corporate citizen.

So choosing a career with Boston Scientific (NYSE: BSX) isnt just business its personal. And if youre a natural problem-solver with the imagination determination and spirit to make a meaningful difference to people worldwide we encourage you to apply and look forward to connecting with you!

At Boston Scientific we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion equality and opportunity for all. By embracing the richness of our unique backgrounds and perspectives we create a better more rewarding place for our employees to work and reflect the patients customers and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code 2.2-4312 (2000) Boston Scientific is providing notification that the unlawful manufacture sale distribution dispensation possession or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Please be advised that certain US based positions including without limitation field sales and service positions that call on hospitals and/or health care centers require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company you will be expected to meet the ongoing requirements for your roles including any new requirements should the Companys policies or protocols change with regard to COVID-19 vaccination.

Among other requirements Boston Scientific maintains specific prohibited substancetesting requirements for safety-sensitive positions. This role is deemed safety-sensitive and as such candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.