Description
Regional Clinical Research Line Manager – Marlborough, MA
Delivering on the promise of medical innovation begins at Boston Scientific!
By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. Join a global organization that is fueled by the diversity and talent of its entire workforce.
General Summary:
This managerial role provides regional management to assigned staff members in the Clinical organization. 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. Influence the development of policies and procedures across functions. Contributes to and adheres to Clinical department budget. Develops and executes Clinical staffing plan. Facilitates the appropriate resourcing of projects, programs, and staff training and development. Makes sure the clinical deliverables are of the highest standards. Interfaces with other departments, senior Clinical management, medical directors, senior functional management, and acts as BSC representative with CRO’s.
Duties and Responsibilities:
- Responsible for managing up to 12 direct reports
- Responsible for training, mentoring, development, and supervising of clinical staff in accordance with BSC policies.
- Develops staffing plans for the clinical functions
- Makes hiring decisions and leverages/allocates appropriate resources to support the clinical organization.
- Interfaces with Project Managers 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.
- Coordinates global harmonization among staff through other clinical functional line managers.
- Responsible for the provision of meaningful metrics to support the clinical organization.
- 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.
- Develops and maintains Clinical Sciences infrastructure such as the drafting and/or reviewing of SOPs and Work Instructions.
- Contributes to the preparation of and manages to budgets for the clinical function.
- Ensures staff is trained on the study specific materials, which include protocols, study tools, etc.
Minimum Education & Experience:
Bachelor’s-level degree required. Degree in science/health related field (e.g., Biology, Nursing, Biomedical or Veterinary Sciences) preferred. 5-7 years experience in clinical/scientific research, nursing, or medical devices/pharmaceutical clinical trials plus. 1-3 years experience managing people and working with clinical professionals within a team, as well as working in a cross-functional product development setting. Previous experience with complex, global trials is preferred.
Working Conditions:
General office environment, with the potential for up to approximately 30% travel to other BSC facilities, research laboratory or hospital settings, and meetings. Potential exposure to blood borne pathogens and other potentially infectious materials
Competency Expectations:
?Ability to understand strategic goals and match the business needs of the company.
?Ability to develop good interpersonal relationships with clinical/medical professionals.
?Good verbal and written communication and presentation skills.
?Must be familiar with the laws, regulations, standards and guidance governing the conduct of clinical studies.
?Ability to independently manage and provide significant tactical and leadership guidance to clinical team.
?Independently motivated.
?Clearly demonstrated people management skills.
Support of Quality Systems:
Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System, and appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented.
The above statements are intended to describe the general nature and level of work being performed by people assigned to
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