Clinical Trial Manager - Cardiology

Location

Marlborough, MA | United States

Job 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 Clinical Trial Manager is responsible for driving the strategy and managing the execution of global clinical studies and clinical programs worldwide through clinical project managers and/or involving departmental or cross-functional teams in support of the organizations business objectives for product development and/or commercialization.

• Leads and drives the project team in the planning, execution and management of all operational aspects of clinical trials.
• Leads, directs and executes clinical studies and/or programs worldwide in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures.
• Establishes and maintains successful collaboration and partnerships with third party vendors in the successful execution of clinical studies to meet business objectives.
• Tracks development of and collaborates with the project team on all internal and external project materials, processes, manuals, plans, committees, study systems and all sponsor required regulatory submissions.
• Ensures the project team maintains a continuous state of audit readiness.
• In collaboration with the project team, leads the proactive identification, assessment, and management of clinical study risks.
• Informs and presents study progress and known risks to Clinical leadership.
• Mentors and coaches all level of Project Management.

Required qualifications:

• Minimum of a bachelors degree and 5 years of related work experience OR minimum of master's degree with 3 years of related work experience
• Medical device clinical trial management experience required (Sponsor or CRO)
• Knowledge of Good Clinical Practices (GCP), FDA regulations and ISO 14155 governing the conduct of clinical trials

Preferred qualifications:

• Experience in cardiovascular medical device trials
• Ability to effectively collaborate across multiple clinical and non-clinical functions
• Ability to develop relationships with investigators, core labs and CROs
• Strong analytical, verbal and written communication skills
• Excellent organizational and problem-solving skills using ingenuity and creativity

Job tags

Salary