Senior Clinical Trial Manager

Additional Location(s): N/A

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:

The Senior Clinical Trial Manager (CTM) will be responsible for the design planning execution and leadership of clinical studies worldwide for BSCs Coronary Therapies portfolio. The Senior CTM is responsible for leading cross-functional clinical teams in support of the organizations business objectives for product development and/or commercialization. The incumbent possesses technical knowledge of products processes and regulatory requirements for clinical trials conducted within a given therapeutic area.

Work Mode:

This role follows a hybrid work model requiring employees to be in our Marlborough office at least three days per week at our BSC offices.

Visa Sponsorship:
Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

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:

• Minimum Bachelors degree in a health-care related field
• Minimum 7 years of related work experience or an equivalent combination of education and work experience
• Minimum 3 years of experience managing clinical trials
• Proven experience with IDE clinical trials.

Preferred qualifications:

• Preferred experience with interventional cardiology medical devices.
• Proven experience in managing the integration of clinical trials from acquired companies.
• Proven experience working with external vendors and Contract Research Organizations (CRO)
• Preference for a professional with a wide range of experience and expertise in a specialized technical or scientific field

Requisition ID:610367

Minimum Salary:$127900

Maximum Salary: $243000

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) see --will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training pertinent education including licensure and certifications among other relevant business or organizational needs. At BSC it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly) non-sales roles may also include variable compensation from time to time (e.g. any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt non-sales roles may also include variable compensation i.e. annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

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 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 identify gender expression veteran status age mental or physical disability genetic information or any other protected class.

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 specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and as such candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.