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Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we’ll give you the opportunity to harness all that’s 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, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
About the role:
The Clinical Trial Manager is responsible for driving the strategy and managing the execution of global clinical studies and clinical programs worldwide through clinical project managers and/or involving departmental or cross-functional teams in support of the organizations business objectives for product development and/or commercialization.
Your responsibilities will include:
- Leads and drives the project team in the planning, execution and management of all operational aspects of Clinical Trials.
- Leads, directs and executes clinical studies and/or programs worldwide in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures.
- Establishes and maintains successful collaboration and partnerships with third party vendors in the successful execution of clinical studies to meet business objectives.
- Tracks development of and collaborates with the project team on all internal and external project materials, processes, manuals, plans, committees, study systems and all sponsor required regulatory submissions.
- Ensures the project team maintains a continuous state of audit readiness.
- In collaboration with the project team, leads the proactive identification, assessment, and management of clinical study risks.
- Informs and presents study progress and known risks to Clinical leadership.
- Mentors and coaches all level of Project Management.
Required qualifications:
- Minimum of a bachelors degree and 5 years of related work experience OR minimum of master's degree with 3 years of related work experience
- Medical device Clinical Trial management experience required (Sponsor or CRO)
- Knowledge of Good Clinical Practices (GCP), FDA regulations and ISO 14155 governing the conduct of Clinical Trials
Preferred qualifications:
- Experience in cardiovascular medical device trials
- Ability to effectively collaborate across multiple clinical and non-clinical functions
- Ability to develop relationships with investigators, core labs and CROs
- Strong analytical, verbal and written communication skills
- Excellent organizational and problem-solving skills using ingenuity and creativity
Requisition ID: 576977
Among other requirements, Boston Scientific maintains specific prohibited substance testing 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.
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) isn’t just business, it’s personal. And if you’re 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 Company’s policies or protocols change with regard to COVID-19 vaccination.
