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Associate Director, Site Management

3 months ago

Arden Hills, Minnesota, United States Boston Scientific Full time

Additional Location(s):US-MN-Arden Hills; US-MN-Mankato/Rochester; US-MN-Maple Grove; US-MN-Minneapolis; US-MN-Minnetonka; US-MN-Northern/Duluth; US-MN-Plymouth

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.

**This role requires hybrid presence (three times per week) at an assigned BSC office location**

About this role:

This role manages the Global Clinical Operations (GCO) North America Site Management team.

Our efforts to align clinical site management and monitoring into a Center of Excellence is one of the many elements required for this role.

Through collaboration with clinical core team members, ensures clinical programs are carried out to a standard consistent with regulatory, corporate and clinical policies and procedures. This incumbent Influences the development of policies and procedures across functions. This incumbent contributes to and adheres to Clinical department budget. They will facilitate the appropriate resourcing of projects, programs, and staff training and development. and interface with other departments, senior Clinical management, medical directors, senior functional management, and acts as BSC representative with CRO's.

Your responsibilities will include:

  • Responsible for managing staff based on a combination of the number of people and the type/level of direct reports and responsible for training, mentoring, development, and supervising of clinical staff in accordance with BSC policies.
  • Develops staffing plans for the clinical function and makes hiring decisions and leverages/allocates appropriate resources to support the clinical organization and interfaces with Project and Program Managers / Directors and other management to develop objectives for clinical functions and to gather performance feedback.
  • Manages interpersonal issues and manages conflict resolutions.
  • Ensures that best practices of study conduct are leveraged across the clinical organization and implements process efficiencies where possible and gives input on global harmonization among staff through other clinical functional line managers.
  • Responsible for the provision of meaningful metrics to support the clinical organization and ensures staff is trained on the study specific materials, which include protocols, study tools, etc.
  • Demonstrates thorough knowledge of and ensures staff adheres to the appropriate application of clinical research conduct, laws, regulations, and standards, and compliance with applicable BSC SOPs and policies.
  • Interfaces as Subject Matter Expert and acts as coach and mentor with vendors performing functional tasks.
  • Responsible to determine, implement and execute vendor oversight activities for outsourced functional tasks.
  • May lead initiatives that improve efficiencies of functional processes.
  • Applies knowledge of business and industry drivers and the factors that maximize performance of area(s) managed; interprets and monitors business trends and market developments to contribute to plans to address business challenges
  • Leads an area within a function (i.e. segment of a division, region/cluster/single country, product area, etc.) typically through M3s/M4s
  • Identifies and resolves complex functional technical, operational and organizational problems
  • Applies professional expertise to recommend solutions and preemptively solves problems with considerations for potential broader impact and applicability to the area, with guidance only in the most complex situations
  • Develops implementation strategies for developed solutions
  • Makes decisions that impact the business results of area -including the support, prioritization, and funding of projects, products, services and/or technologies
  • Influences the opinions and decision making of others internally or with external partners/vendor/customers to achieve department objectives; persuades peers and higher level managers (e.g. M6s-M7s) and builds consensus to take action/ adopt recommendations
  • Leads briefings and technical meetings for internal and external stakeholders concerning specific projects, operations or schedules; converts technical information to compelling business context and advice

Required qualifications:

  • Minimum Bachelor's Degree in any healthcare or related field
  • 10+ years' leadership experience in clinical/scientific research and medical device experience
  • Prior experience working with clinical research centers
  • Prior experience working with clinical trial management systems (e.g. Siebel CTMS, Veeva) and clinical document control systems / eTrial Master Files
  • Prior experience following standard operating procedures (SOP) and work instructions (WIs) in a quality environment

Preferred qualifications:

  • Demonstrated expertise in the application and implementation of risk-based quality management and risk-based monitoring processes
  • Leadership and communication, change management and collaboration skills across all levels of the organization
  • Highly organized with the ability to prioritize
  • Ability to build relationships with key stakeholders
  • Ability to multi-task and work in a very fast-paced environment

Requisition ID:585945

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 is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a prohibited substance freeworkplace. Pursuant to Va. Code * , 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.



Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran