Additional Location(s): US-MA-Marlborough; US-MA-Bedford; US-MA-Boston; US-MA-Burlington; US-MA-Cambridge; US-MA-Lexington; US-MA-Lowell; US-MA-Natick; US-MA-Quincy; US-MA-Western/Springfield; US-MA-Worcester
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.
***This role accommodates hybrid work arrangement thrice a week at Marlborough, MA location***
About this role:
This role provides medical therapeutic and clinical research expertise to the clinical affairs team and other cross-functions of the Endoscopy Business Unit. The Clinical Scientist II will assist in medical analysis, medical authorship, multilevel data interpretation (patient level and medical perspective) in support of quality, regulatory, clinical and product development process and business strategy both internally and externally.
Your responsibilities will include:
- Author and review of clinical research protocols and associated documentation (including but not limited to Informed Consent Forms, Case Report Forms, Investigator Brochures) and Clinical study reports for internal and external studies, including but not limited to Investigator-Sponsored Research and Collaborative Research Studies.
- Support enrollment projections and assist with development of recruitment and retention strategies.
- Collaborate on the review, analysis, and interpretation of study results, including endpoints.
- Provide scientific review of statistical analysis plans, protocol data in development, support in assessing medical monitoring reports.
- Participate in activities related to protocol data review, query resolution and study conduct oversight.
- Support regulatory activities at the protocol level to develop, prepare and respond to regulatory authorities.
- Conduct exploratory analyses of medical data and data extraction collaborating with clinical biostatistics, clinical patient risk, medical safety, quality, and product developments teams, regulatory, HEMA, and Marketing.
- Collaborate with internal teams, and clinical sites to prepare, review and finalize protocol documents.
- Support preparation of abstracts, manuscripts, presentations, and materials for meetings.
- Work with clinical affairs team members to ensure timely and compliant execution of clinical studies processes cross-functionally to identify and find solutions for study vulnerabilities.
Required qualifications:
- Bachelor's degree in sciences or healthcare related field, Masters/ PhD is preferred.
- Minimum 2 years of clinically applied science, or clinical/medical research experience
- Demonstrate understanding of medical science and clinical therapies.
- Ability to travel approximately 20% as needed.
Preferred qualifications:
- Strong scientific writing and communication skills
- Analytical skills, including ability to review and synthesize medical literature efficiently and effectively.
- Prior experience with clinical trials, including IDE, or feasibility studies strongly desired (Sponsor/ CRO (Contract Research Organizations) or other industry experience)
Requisition ID: 586557
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.