Sr Clinical Research Scientist jobs at Boston Scientific in United States, Marlborough

Your responsibilities will include:

• Leading and driving the cross-functional project team in the planning, execution, and operational management of oncology clinical trials
• Designing, directing, and executing global clinical studies in alignment with program strategy, approved budget, and timelines, in compliance with regulatory and operational procedures
• Collaborating on development and oversight of internal and external project materials, including study manuals, systems, and regulatory submissions
• Interfacing and building relationships with external physicians and key opinion leaders (KOLs)
• Managing clinical trial budgets (up to 25%), including monthly tracking, forecasting, and variance analysis
• Providing direction to Contract Research Organizations (CROs) and external vendors
• Ensuring audit readiness and compliance across all clinical trial activities
• Leading proactive risk identification, assessment, and mitigation planning for assigned studies
• Preparing and delivering study updates, presentations, and risk assessments to leadership
• Contributing clinical insights to product development activities and serving as a Clinical team representative on product development teams
• Traveling domestically up to 10–25%, as required

Required qualifications:

• Bachelor’s degree and minimum of 5 years' experience in oncology-related clinical research or equivalent education and work experience
• Minimum of 1 yearof direct oncology clinical trial management experience
• Minimum of 1 yearof financial oversight and budget management experience
• Minimum of 1 yearworking with CROs, vendors, or outsourced clinical operations

Preferred qualifications:

• Experience in early feasibility studies, solid tumor trials, or immuno-oncology (IO) product development
• Background working with engineering or product development teams
• Strong ability to:
• Generate new ideas and approaches by applying creative thinking to complex problems
• Align execution with strategic goals and independently drive action without close supervision
• Collaborate and influence across global, cross-functional teams
• Adapt quickly and stay effective under changing conditions

Maximum Salary: $ 243000

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

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.

About the Role:

At Boston Scientific, the Supply Chain Planner I support the Clinical Supply Chain (CSC) organization by supporting the device distribution and tracking of investigational products from the trial planning phase through final reconciliation of products. This role involves coordinating with internal and external groups to meet clinical trial deliverables while ensuring regulatory compliance. Responsibilities include demand planning, data analysis, inventory management, document tracking, and ensuring clinical objectives are met within time, budget, and compliance parameters.

Your Responsibilities Include:

• Partner with other Clinical Supply Chain team members to complete and approve the Device Management plan prior to the start of study enrollment.
• Participate in the Device Management system user acceptance testing.
• Assist in developing demand plans and ensuring appropriate and timely supply for clinical trials.
• Engage with clinical team, customer care, distribution, and logistics teams to ensure product is distributed in a timely and compliant manner for clinical trials.
• Engage with external groups/vendors, when used, to ensure distribution and processes are in place to support on time enrollment within compliance.
• Monitor trial performance and inventory position as to reduce excess, expired and obsolete inventory (EE&O) risk.
• Using data models and device accountability systems to analyze and ensure that investigational devices are tracked throughout the clinical trial.
• Collaborate with internal and external groups to return and track un-used product into our distribution centers and to final device disposition.
• Support Vendor Management activities with existing or new trials.
• Escalate issues and potential risks to CSC management as applicable.

Qualifications Required:

• Bachelor’s degree in supply chain or equivalent work experience required.
• Strong Analytical skills with ability to structure and perform data analysis.
• Experience solving urgent and complex business challenges.
• Excellent communication and relationship management skills.
• Strong Organization skills to work multiple issues in parallel over time.
• Strong PC skills, including Excel, Word, and Power Point.
• Adhere to procedures and practices that maintain compliance to regulations.

Qualifications Preferred:

• Medical devices/pharmaceutical clinical trials and device distribution experience preferred.
  Sales, Inventory, and Operations Planning (SI&OP) experience is a plus.
• Experience utilizing SAP or other ERP system preferred.

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

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.

Your responsibilities will include:

• Manage pipeline data to support the region in meeting strategic and revenue goals

• Lead onboarding and training for new Territory Managers and Clinical Specialists, including Salesforce App training

• Contribute to national and corporate training initiatives such as Initial Sales Training (IST) and marketing programs

• Own and execute special projects across the supported areas (e.g., inventory management for expiration dates)

• Maintain and analyze business metrics to uncover new business opportunities and support revenue growth

• Oversee tools such as Sales Tracking Scorecard, MBO tracking, and Pending POS/Accounts Receivable reporting

Required qualifications:

• Bachelor’s degree

• Minimum of five years' experience in a sales and/or clinical role, or an equivalent combination of education and experience

• Experience using and training others on the Salesforce App

• Proven project management skills with the ability to manage a large portfolio across multiple territories

• Strong analytical thinking and the ability to convert business metrics into actionable strategies to drive results

• Ability to travel up to 50% within the assigned region

Preferred qualifications:

• MBA

• Experience in medical device sales

• Bachelor’s degree in Nursing, Biology, Kinesiology, or other related science field

The anticipated annualized base amount or range for this full time position will be, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.

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.

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 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.

Spencer Gregory Hale

Serves as a Global Risk Management process owner to drive and support Global Risk Management initiatives and quality goals and priorities. Develops, establishes, and maintains global processes, systems, and practices that meet BSC, customer, and regulatory requirements. Partners with design teams across all divisions and leads global communities of practice (CoP) to drive and improve BSC’s Global Risk Management process, in collaboration with the global risk management sub-process stewards.

Your responsibilities include:

• Demonstrating competence in drafting, editing, and implementing effective Global Risk Management procedures with input from all divisions to support the development and maintenance of products to meet or exceed internal and external requirements.
• Acting on feedback trends identified through QS audit, product submissions, and QMR metrics by driving process improvement projects across the Risk Management Sub-Process.
• Influencing key stakeholders through collaborative community engagement. Helping connect the key SMEs across divisions and capitalizing on networking skills to promote best practice sharing and efficient problem solving.
• Partnering with all upstream and downstream process owners to ensure the right linkages with the Global Risk management Process are maintained (i.e., production and process controls, material controls, post-market support)
• Supporting internal and external audits and audit responses for existing products.
• Monitoring compliance with company policies and procedures.
• Owning Global CAPAs, including proven experience with complex, multi-site/multi-division problem-solving.
• Acting as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Ensuring the development and execution of streamlined business processes which help achieve VIP/Continuous Improvement goals.

Require Qualifications:

• Bachelor's degree in Science, Health, or Engineering.
• Minimum of 5 years of Medical Device Design Controls and Risk Management experience required.
• Understanding of US and International regulations including 21 CFR Part 820, ISO 13485, and EN ISO 14971 is required, as well as knowledge of the Medical Device Directive and EU MDR.

Preferred Qualifications:

• Excellent oral and written communication skills (e.g., giving presentations to peer groups and various levels of management, sharing clear and concise information, managing change effectively using a variety of communication methods and tools, etc.).
• Advanced project management skills (e.g., breaking projects into smaller tasks, coordinating work with other impacted process or document owners, balancing competing priorities, managing expectations on project timelines, etc.).
• Expertise in Microsoft Office Suite programs including, Teams, Excel, PowerPoint, and Word.

Maximum Salary: $ 164500

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

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.

Spencer Gregory Hale

Serves as a Global Risk Management process owner to drive and support Global Risk Management initiatives and quality goals and priorities. Develops, establishes, and maintains global processes, systems, and practices that meet BSC, customer, and regulatory requirements. Partners with design teams across all divisions and leads global communities of practice (CoP) to drive and improve BSC’s Global Risk Management process, in collaboration with the global risk management sub-process stewards.

Your responsibilities include:

• Demonstrating competence in drafting, editing, and implementing effective Global Risk Management procedures with input from all divisions to support the development and maintenance of products to meet or exceed internal and external requirements.
• Acting on feedback trends identified through QS audit, product submissions, and QMR metrics by driving process improvement projects across the Risk Management Sub-Process.
• Influencing key stakeholders through collaborative community engagement. Helping connect the key SMEs across divisions and capitalizing on networking skills to promote best practice sharing and efficient problem solving.
• Partnering with all upstream and downstream process owners to ensure the right linkages with the Global Risk management Process are maintained (i.e., production and process controls, material controls, post-market support)
• Supporting internal and external audits and audit responses for existing products.
• Monitoring compliance with company policies and procedures.
• Owning Global CAPAs, including proven experience with complex, multi-site/multi-division problem-solving.
• Acting as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Ensuring the development and execution of streamlined business processes which help achieve VIP/Continuous Improvement goals.

Require Qualifications:

• Bachelor's degree in Science, Health, or Engineering.
• Minimum of 5 years of Medical Device Design Controls and Risk Management experience required.
• Understanding of US and International regulations including 21 CFR Part 820, ISO 13485, and EN ISO 14971 is required, as well as knowledge of the Medical Device Directive and EU MDR.

Preferred Qualifications:

• Excellent oral and written communication skills (e.g., giving presentations to peer groups and various levels of management, sharing clear and concise information, managing change effectively using a variety of communication methods and tools, etc.).
• Advanced project management skills (e.g., breaking projects into smaller tasks, coordinating work with other impacted process or document owners, balancing competing priorities, managing expectations on project timelines, etc.).
• Expertise in Microsoft Office Suite programs including, Teams, Excel, PowerPoint, and Word.

Maximum Salary: $ 164500

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

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.

Job Responsibilities:

• To identify, order and commission the key process equipment to CGMP in the Operations Engineering Cycle to meet key business objectives

• Engineering process owner for the area.

• Develop and modify manufacturing documentation and procedures to support commercial products as well as the introduction of new products to the production floor (assembly procedures, BOMs, etc.)

• Ensure that new products introduced to the production floor meet business, quality, output and cost goals and objectives

• Develop and modify various manufacturing processes to improve product and process quality and output

• Ensure product/process requirements are met for component, assembly, tooling and supplier specifications

• Perform product/process/vendor qualification activities as required

• Support material discrepancy review and disposition activities (MRB) for existing commercial products

• Develops knowledge in a field to become a recognized leader or authority in an area of specialization and applies this knowledge in leadership roles in the company.

• Eliminate/reduce product/process defects and improve yields. Strong problem solver for technical problems in the area, solves problems from basic engineering principles, theories and concepts.

• Demonstrate a primary commitment to patient safety and product quality

• Support all quality and corrective/preventive actions initiatives (NCEP, CAPA) to achieve quality goals

• Maintain a valid capacity model in co-operation with the line Supervisor and conduct adequate advance planning for required capital

• Capable of training cross functional team members including, engineers, technicians and product builders

• Knowledge of project management.

• Interacts cross functionally and with internal and external customers.

• Ability to develop expert knowledge on BSC systems.

• Willing to travel internationally as part of project team.

• For individual who is assigned calibration engineering role only:

• Provide equipment calibration services necessary to meet company objectives, while assuring measurement traceability to nationally recognized equipment calibration standards and practices.

• Technical SME for Calibration group and SME for internal and external Audit.

• SME for Calibration Management System.

• Perform calibration functions and sets day to day function for calibration group.

• Researches, recommends, and acquires new standards and other capital equipment, providing detailed justifications and cost analysis as required.

• Develops technical engineering reports and complex technical calibration procedures and trains department technicians on new calibration procedures.

• Works directly with Equipment Engineering and Manufacturing Engineering departments to advise on equipment selection, design accommodations for calibration of new equipment and appropriate measurement techniques.

• Provides support and guidance to calibration technicians in performing complex equipment calibrations.

• Supports calibration lab needs regarding such issues as environmental control and new technologies.

• Works with Management to develop the department fiscal year budgets.

• Communicates with the Operations ME function on calibration status.

• Build Quality into all aspects of work by maintaining compliance to all quality requirements.

• Drive “Standard Work” in all aspect of Calibration activity.

Job Requirements:

1. Candidate require process at least Bachelor’s degree in Mechanical Engineering. Preferable in mechanical, Chemical or biomedical.

2. Candidate require has at least 8 years of experience in related field.

3. Prefer candidate from medical device or other regulated industry experience.

4. Demonstrate ability to generate manufacturing documentations, specifications and technical reports in a concise manner, hands on and action-oriented engineer with strong analytical skill.

5. Skill required:

1. Leadership.
2. Exhibits strong engineering knowledge, problem-solving skills.
3. Experienced in sustaining and production working environments.5. Experience in the medical devices manufacturing industry is a plus

Primarily acting as an organizational researcher, this role provides the Talent Analytics & Insights group with technical expertise, developing analytical models with practical, valuable applications in areas such as strategic workforce planning, attracting and retaining talent, employee engagement, high-potential talent identification & development, and employee development.

As a data-driven organization, this role is critical to advancing our analytical maturity by fully utilizing our HR data lake to predict future trends, identify leading indicators, define data limits, and evaluate program success.

Your responsibilities will include:

• Be a technical expert, fluent in the language of data and quickly able to translate a client question into a research question

• Use your technical expertise in data science to lead the prediction and forecasting workstream and build capabilities within HR and cross-functionally using HR data

• Test and validate AI-driven analytical models to ensure accuracy

• Serve as an expert advisor to Talent Analytics team members, consulting on research study design methodologies and conducting analyses based on available data

• Perform deep-dive analyses using traditional statistical, supervised, and unsupervised machine learning techniques to deliver insights on root causes and make recommendations for continuous improvement

• Act as the TA&I data steward, identifying data quality challenges and working with business process owners to drive data consistency

• Provide SME expertise in the design and management of qualitative and quantitative data collection and capture to maximize value from the HR data lake

• Proactively identify research opportunities by mining data to generate practical talent insights for the business

• Participate in collaborative forums within Boston Scientific, sharing methodologies and expertise across functions

• Integrate workforce planning and data elements into Boston Scientific’s planning ecosystem, challenging long-held assumptions before they are systemized

Required qualifications:

• Bachelor’s degree in Business Analytics, HRM/People Analytics, I/O Psychology, or related field

• Minimum of 3 years' experience delivering value in analytics roles

• Minimum of 2 years' experience conducting analyses for workforce planning or predicting supply and demand using supervised and unsupervised machine learning

• Technical expertise in natural language processing, predictive modeling, scenario modeling, and forecasting methods

• Proficiency in R

• Experience with data engineering tasks such as data cleaning, validation, and integration from large and unstructured sources

• Use of AI to drive efficiency in analytics

• Proven experience consulting with stakeholders to define business needs and deliver data-informed solutions

• Demonstrated ability to solve complex and ambiguous problems using analytical rigor and creative thinking

• Strong attention to detail with a track record of producing high-quality, accurate analysis and reporting

• Demonstrated skill in communicating complex data insights in a clear and compelling narrative

• Proven ability to work effectively in a highly collaborative, global, and matrixed team environment

Preferred qualifications:

• Master’s or PhD-level coursework or degree in Business Analytics, HRM/People Analytics, or I/O Psychology

• Experience in survey methodology and design at the business unit or enterprise level

• Background in competency modeling and assessment validation

• Experience using RPA, AI, or other advanced technologies in the analytics space

• Experience with Athena and SQL for data extraction

• Proficiency with Tableau, SQL, and Excel for data visualization and reporting

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

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.