Additional locations: us based
Purpose and passion • comprehensive benefits • life-work integration • community • career growth
At boston scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential levelWith determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challengesTogether, we’re one global team committed to making a difference in people’s lives around the worldThis is a place where you can find a career with meaningful purpose—improving lives through your life’s work.
Clinical trial manager, electrophysiology - remote
About the role:
Combining the most advanced and least-invasive rhythm management technologies available with an unwavering commitment to deep collaboration with healthcare professionals, we’re helping to reduce costs, improve outcomes and enhance patients’ livesThe clinical trial manager is responsible for the design, planning, execution and leadership of clinical studies and clinical programs worldwide as well as leading cross functional clinical teams in support of the organization`s business objectives for product development and/or commercializationPossesses a technical knowledge of products, processes, and regulatory requirements for clinical trials conducted within a given therapeutic area.
Your responsibilities will include:
Writes study protocols, protocol amendments, informed consents, clinical study project timelines and scientific papers for publication by evaluating scientific literature and publications, analyzing scientific data, and staying abreast of current clinical practiceEfforts and leadership support product approval, indication expansion and claim support, and mandated post market requirements.
Leads the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/directionProvides project leadership and scientific expertise throughout the development and implementation of local or global clinical studiesMay lead studies executed by a cro.
Provides clinical input for new product development, post market surveillance, recertification, and business developmentInteracts with various study support groups to assist in clinical strategy, the development of study plans, and project deliverables.
Interacts with regulatory agencies as needed and will use their scientific knowledge to provide directives to staff as well as study sites.
Facilitates communication between sales and marketing, r&d, regulatory affairs, training, senior management, key opinion leaders/investigators, and investigational sites by conducting team meetings, drafting, and sending routine correspondence (e.g., newsletters) and by presenting regular updates to senior staff (bpt/pib, etc.).
May manage clinical study timelines, budget by utilizing the appropriate project management tools, selecting providers, managing vendor contracts, and ensuring expenditures are within budgetary guidelines.
Facilitates regulatory submissions and communications by communicating with regulatory affairs during the submission process.
Presents scientific data by communicating accurate, succinct summaries of clinical study work at industry gatherings, investigational meetings, and regulatory agency meetingsMay author scientific abstracts and/or publications.
Provides accurate progress reports on clinical projects by writing assigned clinical portions of reports for submission to regulatory agencies, institutional review boards, medical ethics committees, etc.
What we`re looking for in you:
Minimum qualifications
Bachelor’s degree
5+ years of related work experience or an equivalent combination of education and work experience
3+ years of experience managing clinical trials
Preferred qualifications
Experience leading clinical trials with investigational devices desired, specifically in the field of electrophysiology or cardiologyAtrial fibrillation/flutter ablation knowledge is strongly preferred.
Strong preference for a professional with a wide range of experience and expertise in a specialized technical field
Ability to apply comprehensive technical knowledge of an electrophysiology to resolve complex issues in creative ways
Ability to use in-depth knowledge of business unit functions and cross-functional group dependencies/relationships
Experience working with and managing external vendors
About us
As a global medical technology leader for more than 35 years, our mission at boston scientific (nyse: bsx) is to transform lives through innovative medical solutions that improve the health of patientsIf you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
Boston scientific is an equal opportunity employer – race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran
Boston scientific maintains a drug-free workplacePursuant to vaCode § 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.
Requisition id: 502558
Nearest major market: minneapolis
Job segment: clinic, medical, manager, marketing manager, law, healthcare, management, marketing, legal
