Additional Location(s): US-MN-Arden Hills
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 will be responsible for the design, planning, execution and leadership of clinical studies and clinical programs worldwide for BSC's Coronary Therapies portfolio. Responsible for leading cross-functional clinical teams in support of the organization's business objectives for product development and/or commercialization. Possesses a technical knowledge of products, processes, and regulatory requirements for clinical trials conducted within a given therapeutic area.
Your responsibilities will include:
- Writes study protocols, protocol amendments, informed consents, clinical study project timelines and scientific papers for publication by evaluating scientific literature and publications, analyzing scientific data and staying abreast of current clinical practice. Efforts and leadership will support product approval, indication expansion and claim support, and mandated post market requirements.
- Leads the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction. Provides project leadership and scientific expertise throughout the development and implementation of local or global clinical studies. May lead studies executed by a CRO.
- Provides clinical input for new product development, post market surveillance, recertification and business development.
- Interacts with various study support groups in order to assist in clinical strategy, the development of study plans, and project deliverables. Interacts with regulatory agencies as needed and will use their scientific knowledge in order to provide directives to staff as well as study sites.
- Facilitates communication between Sales and Marketing, R&D, Regulatory Affairs, Training, Senior Management, Key Opinion Leaders/investigators and investigational sites by conducting team meetings, drafting and sending routine correspondence (e.g., newsletters) and by presenting regular updates to senior staff.
- Manages clinical study timelines, budget by utilizing the appropriate project management tools, selecting providers, managing vendor contracts and ensuring expenditures are within budgetary guidelines.
- Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.
- Presents scientific data by communicating accurate, succinct summaries of clinical study work at industry gatherings, investigational meetings and regulatory agency meetings.
- Provides accurate progress reports on clinical projects by writing assigned clinical portions of reports for submission to regulatory agencies, Institutional Review Boards, Medical Ethics Committees, etc. May include clinical risk management activities including input into Hazard Analyses, product FMEA and IFUs and authorship of Clinical Evaluation documents (CES, CRBA, CDSR) for identification of harms and support of safety performance for product approval.
Required Qualifications:
- Bachelor's degree and 5+ years of related work experience or an equivalent combination of education and work experience.
- Clinical trial experience required.
- Experience working with external vendors and Contract Research Organizations (CRO).
Preferred Qualifications:
- Experience with investigational device clinical trials.
- Experience with interventional cardiology and/or heart failure therapeutic areas.
- Ability to use in-depth knowledge of business unit functions and cross-functional group dependencies/relationships.
- Ability to apply comprehensive technical knowledge of Interventional Cardiology to resolve complex issues in creative ways.
- Preference for a professional with a wide range of experience and expertise in a specialized technical or scientific field.
Requisition ID: 591996
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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran's status, age, mental or physical disability, genetic information or any other protected class.
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.
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