Senior Clinical Trial Specialist at Boston Scientific Corporation Malaysia

Arden Hills, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

23 Feb, 26

Salary

156900.0

Posted On

25 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trials, Project Leadership, Scientific Expertise, Data Analysis, Regulatory Compliance, Communication, Collaboration, Healthcare Provider Contracting, Electrophysiology, Clinical Strategy, Study Plans, Clinical Research, Clinical Operations, Study Protocols, Informed Consents, Study Timelines

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 this role: The Senior Clinical Trial Specialist (CTS) is responsible for the design, planning, execution and leadership of clinical studies and clinical programs worldwide as well as leading cross functional clinical teams in support of the organization's business objectives for product development and/or commercialization. The Sr.CTS also provides support in enrollment, follow-up and closure of clinical trial activities through collaboration with Trial Operations, Regulatory Affairs and the Contract & Budget teams, and with divisional and regional clinical teams. Work Mode: This role follows a hybrid work model, requiring employees to be in our BSC local office at least three days per week. 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: Trial Leadership: Provides project leadership and scientific expertise throughout the development and implementation of local or global clinical studies by supporting the trial manager with writing 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. May lead studies executed by a CRO. Trial Execution: Interacts with various study support groups in order to assist in clinical strategy, the development of study plans, and project deliverables. Communication Ensures clear written communication to clinical sites and facilitates communication between Sales and Marketing, R&D, Regulatory Affairs, Training, Senior Management, Key Opinion Leaders/investigators through team meetings, study memos, and general correspondence (e.g. newsletters). Collaboration: Participates in study-specific meetings, teleconferences and trainings. Collaborates with cross-functional team members and study sites throughout all study phases. Data Analysis Presents scientific data by communicating accurate, succinct summaries of clinical study work at study specific meetings, industry gatherings, investigational meetings and regulatory agency meetings. May author scientific abstracts and/or publications. Regulatory Compliance: 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. Support regulatory inspection activities as required. Documentation: Manages study contracts and invoices, request / collection of relevant (i.e. Regulatory Docs, FDF, CV/ML) investigator / site documentation, review and approval of subset of documents in applicable database. Performs healthcare provider contracting and invoice reconciliation for study committee members. Required qualifications: Minimum Bachelor's Degree, or an equivalent combination of experience and education Proven clinical trial research experience in a medical device industry required Minimum 3 years of experience in Clinical Trials required Proven working experience with clinical trial teams, regulatory teams, global Clinical operations, and clinical research site personnel Preferred qualifications: Experience working with Clinical Trial Management and Electronic Data Capture systems Electrophysiology experience preferred HCP contracting experience preferred Requisition ID: 618578 Minimum Salary: $ 82600 Maximum Salary: $ 156900 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 Specialist is responsible for the design, planning, execution, and leadership of clinical studies and programs worldwide. This role involves collaboration with various teams to ensure successful trial execution and compliance with regulatory standards.