Boston Scientific Associate Clinical Project Manager 

United States, Massachusetts, Marlborough 

953367191

US-MA-Marlborough; US-MA-Bedford; US-MA-Boston; US-MA-Burlington; US-MA-Cambridge; US-MA-Lexington; US-MA-Lowell; US-MA-Natick; US-MA-Quincy; US-MA-Western/Springfield; US-MA-Worcester

**Hybrid work arrangement (three times a week), Marlborough, MA**

The Associate Clinical Project Manager (Assoc. CPM) oversees clinical project management in the areas of product development and commercialization through the execution of clinical trials. The Associate CPM has knowledge of clinical project processes and can execute trial-related activities with or without guidance as necessary. The Associate CPM is familiar with internal Clinical SOPs, has knowledge of good clinical practice (GCP), and firmly understands the clinical study protocol.
Your responsibilities will include:

• Contributing to protocol, informed consent form (ICF), Investigator’s Brochure (IB), case report form (CRF), and Regulatory submission creation
• Executing confidential disclosure agreements (CDAs) and supporting/negotiating creation of clinical study agreements (CSAs) and site budgets
• Executing study payments, managing device tracking/accountability, and overseeing site management activities
• Overseeing study monitoring activities, including reviewing/approving interim monitoring visit reports and conducting/attending site initiation visits
• Conducting clinical project meetings, including study compliance/core team meetings and attending cross-functional clinical project meetings, including clinical trial safety reviews
• Drafting/managing project plan, in accordance with the study goals and timing set by management
• Actively evaluating the project for opportunities to improve performance, as well as continuously monitoring risk and mitigating as appropriate
• Using internal systems to update project milestones and study timelines
• Maintaining audit readiness at all times
• Managing study master file
• Overseeing creation of site regulatory binders and other site materials

Required qualifications:

• Minimum of Bachelor's degree in addition to 4 plus years of related work experience or an equivalent combination of education and work experience
• Proven experience in clinical research, clinical affairs, or regulatory affairs (optional) in the medical device or pharmaceuticals industry
• Advanced analytical skills, including ability to review and synthesize medical literature efficiently and effectively

Preferred qualifications:

• Preferably three years of project coordination/project management experience, preferably with IDE studies
• Preferably strong leadership, verbal, and written communication skills, with the ability to navigate a fast-paced environment, develop solution-driven teams, and manage multiple projects simultaneously in a tight deadline-driven environment
• Proven ability to work effectively and collaboratively across functions, including with R&D, Regulatory, Manufacturing, Supply Chain, Legal, Quality Assurance, Safety, Data Management, and Biostatistics
  

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.