Senior Clinical Trial Manager at Boston Scientific Corporation Malaysia

Maple Grove, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Mar, 26

Salary

243000.0

Posted On

02 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trial Management, Regulatory Compliance, Project Management, Risk Management, Vendor Management, Budget Management, Protocol Development, Scientific Communication, Cross-Functional Collaboration, Clinical Operations, Good Clinical Practices, Medical Device Experience, Cardiovascular Knowledge, Audit Readiness, Data Analysis, Team Leadership

Industry

Medical Equipment Manufacturing

Description

Additional Location(s): N/A 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 Senior Clinical Trial Manager will lead the design, planning, execution, and oversight of global clinical studies for the Renal Denervation portfolio. This individual will manage cross-functional clinical teams to support business objectives related to both product development and commercialization. The incumbent will bring deep expertise in clinical trial operations, a strong understanding of regulatory requirements, and technical knowledge specific to the relevant therapeutic area. Visa sponsorship: Boston Scientific will not offer sponsorship or take sponsorship of an employment visa at this time. Work mode: This is a hybrid position (in office minimum three days per week) to be located in Arbor Lakes, MN. Your responsibilities will include: 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. Writes study protocols, protocol amendments, informed consents, project plans and timelines; stays abreast of current clinical practice by analyzing scientific data from literature and publications. Manages clinical study timelines, budget by utilizing the appropriate project management tools, selecting providers, managing vendor contracts and ensuring expenditures are within budgetary guidelines. Tracks development of and collaborates with the study team on all internal and external project materials, processes, manuals, plans, committees, vendors, study systems and all sponsor required regulatory submissions. Ensures the study team maintains a continuous state of audit readiness. In collaboration with the study team, leads the proactive identification, assessment, and management of clinical study risks and emerging trends. Facilitates communication between Sales & Marketing, Medical Affairs, Regulatory Affairs, R&D, 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 management. Interacts with regulatory agencies as needed and will use their scientific knowledge to provide directives to staff as well as study sites. 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, Ethics Committees, etc. Required qualifications : Minimum 8 years related work experience with Bachelor's degree or 6 years with Master's degree Proven Clinical trial experience required (Sponsor or CRO) Advanced knowledge of Good Clinical Practices (GCP), ISO 14155 and FDA regulations governing the conduct of clinical trials Prior or current experience working with external vendors and Contract Research Organizations (CRO) Preferred qualifications: Current or previous experience with medical device clinical trials Current or previous experience with cardiovascular therapeutic areas Proven ability to use in-depth knowledge of business unit functions and cross-functional group dependencies/relationships Requisition ID: 619390 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 www.bscbenefitsconnect.com—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) 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 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 Company's policies or protocols change with regard to COVID-19 vaccination. Among other requirements, Boston Scientific maintains specific prohibited substance test 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.

Responsibilities

The Senior Clinical Trial Manager will lead the design, planning, execution, and oversight of global clinical studies for the Renal Denervation portfolio. This role involves managing cross-functional clinical teams to support business objectives related to product development and commercialization.