Additional Location(s): 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
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.
Hybrid work arrangement (three times a week), Marlborough, MA
About the role:
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
Requisition ID: 588904
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.
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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran’s status, age, mental or physical disability, genetic information or any other protected class.
Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), 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.
Nearest Major Market: Boston
Job Segment: Clinical Research, Medical Research, Project Manager, Supply Chain Manager, Compliance, Healthcare, Technology, Operations, Legal
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